MASTER PLAN OF ACTION - Bahagian Perkhidmatan · PDF fileaction for Malaysian National Medicines Policy 2nd Edition (2012): ... Pharmacists and medical doctors from public and private

MINISTRY OF HEALTH MALAYSIA

Malaysian National Medicines Policy2nd Edition, 2012

MASTER PLANOF ACTION

MASTER PLANOF ACTION

Malaysian National Medicines Policy2nd Edition, 2012

MINISTRY OF HEALTH MALAYSIA

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012II

First print 2014

Copyright © 2014 byPharmaceutical Services Division

Ministry of Health MalaysiaLot 36, Jalan Universiti, 43650 Petaling Jaya, Selangor

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing.

The only exception is by a reviewer, who may quote short excerpts in a review.

ISBN 978-967-5570-51-3

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 III

ACKNOWLEDGEMENTS .........................................................................................................vi

EDITORIAL COMMITEE .........................................................................................................vii

MALAYSIAN NATIONAL MEDICINES POLICY (MNMP) Introduction ............................................................................................................................... 1

1. GOVERNANCE IN MEDICINES .......................................................................................... 3

AIM ...................................................................................................................................4

STRATEGY ......................................................................................................................4

Strategy 1 : Code of Conduct ..................................................................................4

Strategy 2 : Legislation and Regulations ...............................................................4

2. QUALITY, SAFETY AND EFFICACY OF MEDICINES......................................................... 5

AIM ...................................................................................................................................6

STRATEGY ......................................................................................................................6

LEGISLATION AND REGULATIONS ..............................................................................7

Strategy 1: National Pharmaceutical Control Bureau (NPCB) .............................. 7

Strategy 2: Regulating Premises that Supply Medicines ....................................8

Strategy 3: Effective Enforcement .........................................................................9

Strategy 4: Medicines Advertisement and Promotion .........................................10

Strategy 5: Counterfeit Medicines .........................................................................10

PHARMACEUTICAL QUALITY ASSURANCE ............................................................... 11

Strategy 1: Post-Marketing Surveillance ............................................................ 11

Strategy 2: Management of Complaints about Medicines ................................ 11

3. ACCESS TO MEDICINES .................................................................................................. 13

AIM .................................................................................................................................14

STRATEGY ....................................................................................................................14

AVAILABILITY OF MEDICINES .....................................................................................16

A) SELECTION OF MEDICINES ...................................................................................16

Strategy 1: National Medicines Formulary ..........................................................16

Strategy 2: National Essential Medicines List (NEML) ......................................17

Strategy 3: Drug and Therapeutic Committee .....................................................17

CONTENTS

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012Iv

Strategy 4: Traditional and Complementary Medicines Formulary ................... 18

Strategy 5: Life-saving Medicines and Orphan Medicines ................................18

Strategy 6: Halal Medicines ..................................................................................19

B) SUPPLY OF MEDICINES ..........................................................................................20

Strategy 1: Procurement ........................................................................................20

Strategy 2: Distribution and Storage of Medicines ...........................................21

Strategy 3: Disposal of Medicines ........................................................................21

Strategy 4: Medicines Supply in Emergency Situations and Medicines Dona-tions .........................................................................................................................22

AFFORDABILITY OF MEDICINES ................................................................................22

A) NATIONAL PRICING REFERENCE FOR MEDICINES ..........................................22

Strategy 1: Transparency on Price Information ...................................................22

Strategy 2: Monitoring of Price Information .........................................................23

Strategy 3: Tariffs and Duties ...............................................................................23

B) FINANCING FOR MEDICINES .................................................................................24

C) GENERIC MEDICINES POLICY ...............................................................................24

Strategy 1: Prescribing in generic International Non-proprietary Name (INN) 24

Strategy 2: Procurement of all medicines by generic INN .................................25

Strategy 3: Selection for procurement in generic INN ........................................25

Strategy 4: Generic Labelling Practice .................................................................25

Strategy 5: Interchangeable and Non-interchangeable Medicines ................... 25

Strategy 6: Generic Medicine Substitution For All Interchangeable Medicines 26

Strategy 7: Appropriate incentives to promote the use of generic medicines and their production in the country .................................................26

4. QUALITY USE OF MEDICINES ......................................................................................... 27

AIM .................................................................................................................................28

STRATEGY ...................................................................................................................28

DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE ......... 29

EDUCATION AND TRAINING ........................................................................................30

Strategy 1: Healthcare Providers ..........................................................................30

Strategy 2: Consumers ..........................................................................................31

Strategy 3: Pharmaceutical Industry ..................................................................31

Strategy 4: Media ...................................................................................................32

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 v

PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES ............. 32

Strategy 1: Healthcare Providers .........................................................................32

Strategy 2: Consumers ..........................................................................................32

Strategy 3: Pharmaceutical Industry ....................................................................32

Strategy 4: Media ...................................................................................................33

STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE PROVIDERS ....... 33

RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES ....................... 33

5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY .......................... 35

AIM .................................................................................................................................36

STRATEGY ....................................................................................................................36

HUMAN RESOURCE DEVELOPMENT .........................................................................37

RESEARCH AND DEVELOPMENT ...............................................................................37

TECHNICAL COLLABORATION AND PARTNERSHIP .................................................38

A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY ...............................38

Strategy 1: Domestic Pharmaceutical Manufacturing ........................................38

LIST OF ORGANISING COMMITTEE MEMBERS ................................................................ 39

PANEL DISCUSSION MEMBERS.......................................................................................... 40

LIST OF PARTICIPANTS ....................................................................................................... 41

ABBREVIATIONS .................................................................................................................. 46

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012vI

ACKNOWLEDGEMENTS

The Pharmaceutical Services Division (PSD) of the Ministry of Health would like to thank the following participants and stakeholders for their support and contribution in the preparation of this master plan of

action for Malaysian National Medicines Policy 2nd Edition (2012):

Pharmaceutical Services Division, State Health DepartmentsNational Pharmaceutical Control Bureau

Medical Development Division, Ministry of HealthHuman Resource Division, Ministry of Health

Policy and International Relations Division, Ministry of HealthProcurement and Privatisation Division, Ministry of Health

Traditional and Complementary Medicine Division, Ministry of HealthTraining Management Unit, Ministry of Health

Educational Policy Planning and Research Division, Ministry of EducationHealth Services Division of the Malaysian Armed Forces HQ, Ministry of Defence

Forest Research Institute Malaysia (FRIM)Malaysia Biotechnology Corporation Sdn. Bhd.

Malaysia Department of Islamic Development (JAKIM)Malaysian Investment Development Authority (MIDA)

International Islamic University Malaysia (IIUM)University of Malaya (UM)

University Technology MARA (UiTM) Universiti Kebangsaan Malaysia Medical Centre (UKMMC)

University Malaya Medical Centre (UMMC)Malaysian Medical Association (MMA)

Malaysian Pharmaceutical Society (MPS)Malaysian Academy of Pharmacy

Association of Private Hospitals Malaysia (APHM)Consumer Association of Penang (CAP)

Direct Selling Association of Malaysia (DSAM)Federation of Private Medical Practitioners’ Associations Malaysia (FPMPAM)

Malaysian Organisation of Pharmaceutical Industries (MOPI)Malaysian Association of Pharmaceutical Suppliers (MAPS)

MERCY MalaysiaPharmaceutical Association of Malaysia (PhAMA)

Pharmacists and medical doctors from public and private hospitals.

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 vII

EDITORIAL COMMITEE

ADVISORDr. Nour Hanah binti Othman

EDITORIAL COMMITEEMs. Hasnizan binti Hasan

Ms. Bibi Faridha binti Mohd SallehMs. Lau Ling Wei

Ms. Melanie binti HassimMs. Phuar Hsiao Ling

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012

MASTER PLAN OF ACTIONMALAYSIAN NATIONAL MEDICINES POLICY • 2ND EDITION, 2012 1

MALAYSIAN NATIONAL MEDICINES POLICY (MNMP)

INTRODUCTIONIn September 2013, a workshop involving relevant stakeholders from the government agencies and private institutions was conducted towards preparation of Master Plan of Action for second term of MNMP. The efforts from this workshop yielded this revised edition of MNMP Master Plan of Action.

The objective of the Malaysian National Medicines Policy is to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality to improve health outcomes of the people.

The policy implementation from the first term has shown tremendous positive outcomes and transformation. Achievements in establishing a comprehensive regulation system, strengthening of the laws and regulations, creating a robust pharmaceutical industry as well as developing an extensive pharmaceutical distribution network were observed. Nevertheless, improvement can still be adopted in several areas through reinforcement and embracing new ideas abiding to the policy objective.

With the revision of the MNMP, new policy statements and strategies are introduced for the pharmaceutical and health sectors to move forward and to provide for the present needs of the nation, as well as to improve and support existing government policies in line with current global developments. Four core components and four supporting components of the original policy had been reorganized. These resulted in five components as followed:

i. Governance in Medicines

ii. Quality, Safety and Efficacy of Medicines

iii. Access to Medicines

iv. Quality Use of Medicines

v. Partnership and Collaboration for the Healthcare Industry

Alongside the formation of the revised edition of MNMP, an appropriate and practical Plan of Action was developed based on the newly-organized components and the strategies outlined in the policy. With the reconciliation of efforts from all the stakeholders, it is very much anticipated that the implementation of the Plan of Action will bring a remarkable impact to the health of the nation.


1. GOVERNANCE IN MEDICINES



1. GOVERNANCE IN MEDICINES

POLICYGood governance, practices, conduct and professionalism shall be emphasised within the healthcare industry towards achieving optimal health outcomes.

AIM

• To have appropriate governance that ensures the provision of safe, effective and affordable medicines within the best practice environment.

• To ensure all stakeholders are responsible for conducting themselves in an ethical and professional manner.

• To ensure regulations facilitate and support the provision of safe, effective and affordable medicines.

STRATEGY

Strategy 1 : Code of Conduct

No. Activities Implementation Timeline Indicators Targets Stakeholder

1. Establish committee to review current code of conduct (CoC)

2014 Formation of CoC Review committee

2014 DUNas Secretariat

2. Identify and review current CoC for all healthcare stakeholders

2015 Number of CoC reviewed

All stakeholders

DUNas Secretariat/Relevant stakeholders

3. Identify gaps within the existing CoC

2015 Set criteria/ framework for CoC review

Yes DUNas Secretariat/ Relevant stakeholders

Strategy 2 : Legislation and Regulations


1. Development and strengthening the existing directives and guidelines under the proposed Pharmacy Act

2013-2016 Number of directives and guidelines developed

Upon effective date of new Pharmacy Act

Enforcement Pharmacy / Relevant Stakeholders


2. QUALITY, SAFETY AND EFFICACY OF MEDICINES


2. QUALITY, SAFETY AND EFFICACY OF MEDICINES

POLICYOnly safe, efficacious and quality medicines that meet approved standards and specifications shall be registered and made available for sale and use by all consumers in Malaysia.

AIM

• To ensure that medicines marketed for consumers are safe, effective and of quality, and to promote quality use of medicines to meet the health needs of the nation.

STRATEGYThe aim shall be achieved by strengthening the medicines regulatory system through a comprehensive medicines legislation framework, enhanced measures for pharmaceutical quality assurance and effective post-marketing surveillance with positive cooperation and collaboration between the regulators and the relevant stakeholders.

LEGISLATION AND REGULATIONS

Strategy 1 : National Pharmaceutical Control Bureau (NPCB)

Strategy 2 : Regulating Premises that Supply Medicines

Strategy 3 : Effective Enforcement

Strategy 4 : Medicines Advertisement and Promotion

Strategy 5 : Counterfeit Medicines

PHARMACEUTICAL QUALITY ASSURANCE

Strategy 1 : Management of Complaints about Medicines

Strategy 2 : Post-Marketing Surveillance


LEGISLATION AND REGULATIONS

Strategy 1: National Pharmaceutical Control Bureau (NPCB)


1. In support of the transformation in the Malaysian healthcare programme, the NPCB is to be restructured as an autonomous body:

Pharmaceutical Services

Division (PSD) & NPCBa) Preparation of proposal

for new structure and function of NPCB for MOH policy decision

2014 Is the proposal for new structure and function of NPCB ready?

Yes(by early

2015)

b) Application for financial allocation under Dasar Baru 2015 for consultancy services in drafting the bill for NPCB to become an autonomous body

2014 Is the financial allocation under Dasar Baru 2015 applied?

Yes(by end of

2015)

c) To conduct Regulation Impact Assessment

2015 Regulation Impact Assessment done

Yes(by 2015)

d) To prepare for the bill to Attorney General

2015 Bill prepared to Attorney General (AG)

Yes(by 2015)

2. Ensuring/enhancing all regulatory requirements meet/ at par with international standards:

NPCB

a) MoU participation 2015 Technical bilateral with other Regulatory Agency

100%

b) Joint inspection and assessment

i) 2016(subject to PIC/S schedule/ invitation)

Participation in Joint inspection with PIC/S team

Yes

ii) On-going Participation in Joint assessment with PIC/S team

Yes

iii) Q4 2017 Participation in joint assessment with OECD GLP team

Yes

c) To be *fully functional National Drug Regulatory Agency (NDRA) in Biologics and Vaccines

Q1 2017 i) Fully functional NDRA in Vaccines

Yes

ii) Fully functional NDRA in Biologics

Yes



3. Drafting and preparing guideline for cell and gene therapy

Q4 2014 Establishment and implementation of the guideline

Yes(by Q4 2014)

NPCB

4. a) Establishing (drafting and preparing) guideline on efficacy claims for herbal products

2015 Establish and implement guideline

Yes(by Q4 2014)

NPCB

b) Evaluating efficacy claims for herbal products

2015 List of application received and evaluated

Yes NPCB

5. Requirement for non-clinical studies for new products registered under NCE and biotechnology to comply with OECD GLP principles

2015 Percentage of NCE and biotechnology products with non-clinical studies complying to OECD GLP principles

100% NPCB, Industrial

Stakeholders

6. Regulation of API manufacturers exporting to EU

Starting July 2013

Percentage of written confirmation (GMP certificate) being accepted by EU

100% NPCB

*Fully functional = NDRA who has passed the WHO assessment for a list of 6 functions as below: i. Function 1: Marketing Authorisation and Licensing Activitiesii. Function 2: Pharmacovigilance Activities including surveillance of Adverse Events Following Immunization (AEFI)iii. Function 3: NRA Lot Releaseiv. Function 4: Laboratory Accessv. Function 5: Regulatory inspectionsvi. Function 6: Regulatory oversight on clinical trials

Strategy 2: Regulating Premises that Supply Medicines


1. To authorise all retailers dealing with registered products and cosmetics

Upon effective date of new

Pharmacy Act

Percentage of authorised retail premises committing offence

TBD Local Authorities,

PSD

2. Inspection on retail premises dealing with medicinal product

On-going Percentage of retail premises in compliance with Pharmacy Legislation

80% PSD


Strategy 3: Effective Enforcement


1. Inspection of sterile preparation facilities (Cytotoxic Drug Reconstitution and Total Parenteral Nutrition) in healthcare establishment

2017 Percentage of sterile preparation facilities of private and government healthcare establishment inspected

More than 80%

NPCB

2. To ensure all importers of vaccines and blood products comply with cold chain requirement during products distribution (to the extent of importers)

2014 – 2015 Percentage of batches of vaccines and blood products that comply with cold chain requirement

100% NPCB

3. To ensure that all imported products* marketed in Malaysia: NPCB

a) Manufactured by a manufacturer that has been inspected by any PIC/S Participating Authorities or PIC/S partners

2017 Percentage of imported products manufactured by a manufacturer that has been inspected by PIC/S Participating Authority or PIC/S partners through acceptance of GMP certificate

100%

b) GMP facilities inspected by NPCB

2017 Percentage of Foreign GMP Inspections conducted

100% NPCB

c) BE conducted in accredited BE centres (for imported product that requires BE)

2017 Percentage of imported product with BE from an accredited BE centre

100% NPCB

*Excluding Traditional products, Health Supplements and Veterinary products


Strategy 4: Medicines Advertisement and Promotion


1. Regulate all advertisement and promotion of drugs (including health supplements and traditional medicines) through:

PSD, Media Associations

a) Media screening (PSD) On-going Percentage of advertisements in violation of regulations on the ethical promotion of drugs

Not more than 10%

b) Pre-approval (PSD) 2016 – 2017 (abolished upon New Pharmacy

Act)

c) Self-regulation (Industry)

2016 – 2017(upon effective

date of New Pharmacy Act)

Percentage of action taken for advertisements in violation of regulations

100%

Strategy 5: Counterfeit Medicines


1. Monitoring of retailers and wholesaler through inspection

2016 – 2017(upon effective

date of New Pharmacy Act)

Percentage of counterfeit medicines seized

TBD (to get

baseline data)

Local Authorities,

PSD

2. Public Awareness and roadshow on counterfeit/ SSFFC issues

On-going Number of activities conducted

Not less than 50 per year

PSD

3. Comprehensive monitoring of illegal online sale of medicine by Pharmacy Digital Forensic Unit

2015

Percentage of websites selling medicine illegally for which action is taken

Not less than 50%

TBD (to get

baseline data)

PSD, MCMC


PHARMACEUTICAL QUALITY ASSURANCE

Strategy 1: Post-Marketing Surveillance


1. To ensure quality of vaccines imported by reviewing lot summary protocol of imported vaccines

2014(concurrent

with ‘Effective Enforcement’

activity: cold chain

requirement)

i) Percentage of lot summary protocol reviewed

100% NPCB

ii) Percentage of lot release certificate released

TBD(to get

baseline data)

NPCB and Industrial

Stakeholders

2. Adverse event following immunization (AEFI) monitoring programme

On-going Percentage of investigation of serious AEFI

100% NPCB

3. Sampling of registered products

Starting Jan 2013 i) Percentage of products within the registration period being sampled

100% NPCB

ii) Percentage of products sampled

50%

4. Action taken over products found non-conforming to its quality specification

On-going Percentage of *regulatory action taken over non-conforming products

100% NPCB

5. Enhancement of training on ADR reporting for Healthcare Professional to improve quality of ADR reports

On-going WHO Report #Completeness Score (0 – 1)

2013: 0.52014-2015:

target 0.62015-2017:

target > 0.7

NPCB

*Action taken by regulator such as warning, product recall, suspension or cancellation of product registration#Completeness score = a measure of the amount of information on Individual Case Safety Reports as appear in VigiBase (0 = Poor quality ICSR, 1 = Good quality ICSR)

Strategy 2: Management of Complaints about Medicines


1. Investigation of complaints on registered products

On-going Percentage of complaints investigated and resolved within 30 days

Not less than 85%

NPCB



3. ACCESS TO MEDICINES


3. ACCESS TO MEDICINES

POLICY An efficient and integrated medicines management and supply network shall be maintained. The pharmaceutical industry shall be organised and regulated to create incentives and foster competition in medicine prices. Appropriate financing mechanisms shall be developed to ensure essential medicines needed for quality healthcare are affordable.

AIM

• To ensure adequate, continuous and equitable access to quality, safe, effective and affordable medicines towards achieving optimal health outcomes.

STRATEGYThe aim shall be achieved by ensuring the availability and affordability of medicines through:

• A fair and transparent medicines selection mechanism in accordance with the country’s health needs by emphasising clinical effectiveness and cost-effectiveness of treatments

• An efficient and effective procurement mechanism and supply chain network of quality medicines

• An efficient financing management mechanism for optimising health outcomes to ensure value for money

AVAILABILITY OF MEDICINE

A) SELECTION OF MEDICINES

Strategy 1 : National Medicines Formulary

Strategy 2 : National Essential Medicines List (NEML)

Strategy 3 : Drug and Therapeutic Committee

Strategy 4 : Traditional and Complementary Medicines Formulary

Strategy 5 : Life-saving Medicines and Orphan Medicines

Strategy 6 : Halal Medicines

B) SUPPLY OF MEDICINES

Strategy 1 : Procurement

Strategy 2 : Distribution and Storage of Medicines

Strategy 3 : Disposal of Medicines

Strategy 4 : Medicines Supply in Emergency Situations and Medicines Donations


AFFORDABILITY OF MEDICINE

A) NATIONAL PRICING REFERENCE FOR MEDICINES

Strategy 1 : Transparency on Price Information

Strategy 2 : Monitoring of Price Information

Strategy 3 : Tariffs and Duties

B) FINANCING FOR MEDICINES

C) GENERIC MEDICINES POLICY

Strategy 1 : Prescribing in Generic International Non-proprietary Name (INN)

Strategy 2 : Procurement in Generic International Non-proprietary Name (INN)

Strategy 3 : Selection for Procurement

Strategy 4 : Generic Labelling Practice

Strategy 5 : List of Interchangeable and Non-interchangeable Medicines

Strategy 6 : Generic Medicine Substitution

Strategy 7 : Promoting the Use of Generic Medicines


AVAILABILITY OF MEDICINES

A) SELECTION OF MEDICINES


1. Establish National Pharmacoeconomic implementation road map

2014 Roadmap formed Road map National Health Economic

MOH, MOD,MOE, private hospitals, PhAMA, MAPS, MOPI, academicians, service provider (e.g.: CRO)

2. Implementation Road Map:Phase Ii) Prioritise the therapeutic area for pharmacoeconomics evaluation

2014 – 2017 Number of therapeutic area identified

Minimum 1 therapeutic area/ year

ii) Submission of PE local data for review of formulary

Number of local PE study

Minimum 1 local PE study

iii) Establishment of Centre of Pharmacoeconomics

Number of PE centres Number of experts identified and appointed

1 PE centre Minimum 5

Phase IIIdentify and appoint experts from MOH, MOE, MOD

2016 – 2017

Strategy 1: National Medicines Formulary


1. a) Form NMF revision committee (temporary committee)

2014 – 2015 Committee formed Committee formed by 2015

MOH, MOD, MOE, PhAMA, MAPS, MOPI, APHM, FPMPAM, academicians, service provider (e.g.: MCO)

b) Development of guideline for inclusion of medicines into the NMF

2016 Guideline developed Guideline developed by 2016

c) Establish NMF 1st draft 2016 – 2017 NMF drafted NMF draft ready by 2017


Strategy 2: National Essential Medicines List (NEML)


1. a) Periodic multisectoral discussions to revise and update NEML every 2-3 years

2014 and 2017 Number of revisions done

2 times(2014 and 2017)

MOH, MOE, MOD, PhAMA, MPS, APHM, MOPI, *FPMPAMb) Publication of 4th

edition of NEML2014 NEML 4th edition

publishedNEML ready to be used by 2014

c) Conduct NEML awareness to stakeholders

2015 Number of sessions organized

50 sessions (follow DUNas target)

Strategy 3: Drug and Therapeutic Committee


1. Form / enhance National *Drug Therapeutic Committee (NDTC)

2014 – 2015 Committee formed Committees formed, TOR formulated and functioning by 2015

MOH, MOE, MOD, APHM

2. Form / enhance *Drug Therapeutic Committee of institutions and local health facilities

2014 – 2015 Committee formed

* Drug to be changed to medicine


Strategy 4: Traditional and Complementary Medicines Formulary


1. a) Set up technical working group comprising health and traditional practitioners, experts in phytotherapy, pharmacognosy, toxicology, herbal medicine and others

2017 TWG formed TWG formed by 2015

BPTK, FRIM, IMR, TCM associations, Traditional Practitioner Body, PSD, NPCB

b) Form National TCM Formulary committee

2017 Committee formed Committee formed by 2015

c) Formulate TOR for National TCM Formulary committee

2017 TOR formulated TOR formulated by 2017

d) Establish a framework and process of TCM Formulary

2017 Framework established

Framework ready by 2017

Strategy 5: Life-saving Medicines and Orphan Medicines


1. Develop guidelines on handling of *orphan medicines and *life-saving medicines

2015 Guideline developed Guideline developed by 2015

PhAMA, MOPI, MAPS, MPS, BPP, MRDS

2. To review list of orphan medicines and life-saving medicines

On-going Official list available 2015

* Orphan medicine: for rare disease or not commercially viable to supply* Life-saving medicine: require for immediate administration within minutes post or during medical emergency


Strategy 6: Halal Medicines


1. To review the Drug Registration Guidance Document (*Use of Halal Logo)

2014 Revision of Drug Registration Guidance Document (DRGD)

Document revised(**Use of Halal Logo)

NPCB

2. Awareness on MS2424: 2012 Halal Pharmaceutical-General Guideline and MS1900:QMS from Islamic Perspective to the industry stakeholders

2014 – 2016 Number of manufacturer exposed to MS2424: 2012 and MS1900: QMS

60 Manufacturers exposed to MS2424: 2012 and MS1900: QMS (100%)

NPCB

3. To create a list of Halal certified medicines with regular updates

2015 List of Halal certified medicines made available

List of Halal certified medicines made available by 2015

JAKIM

Previous DRGD:*Halal logo may be used voluntarily on registered product label for the following categories, for both local and export market, provided that such products have been certified and approved halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM):

a) Non-scheduled poison, excluding parenteral dosage form and veterinary products;

(Reference: Circular (95)dlm.NPCB/PPP/01/03 Jld. 2)

b) Health supplements;

c) Natural products; and

d) Cosmetics

Current DRGD:** Halal logo may be used voluntarily on registered product label for the following categories, for both local and export market, provided that such products have been certified and approved halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM):

a) Non-scheduled poison, excluding veterinary products;

(Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2; (6)dlm.BPFK/PPP/07/25 )

b) Health supplements;

c) Natural products; and

d) Cosmetics.


B) SUPPLY OF MEDICINES

Strategy 1: Procurement


1. Develop guidelines for medicine procurement process in public and private sector APHM, MPS, PSD, BPP, Bahagian Kewangan KKM, Association of Private Medical Practitioners, MCPG MOE, Ministry of Defence, PhAMA, MOPI, “Bumi agent association”

a) Form a committee and assign TOR

2014 Committee members appointed, TOR assigned

Yes

b) Mapping of existing procurement process (public and private)

2014 Procurement process mapped

Yes

c) Development of medicine procurement guideline

2014 – 2015 First draft of guideline developed

Yes by end of 2015

d) Publication of the procurement guidelines

2015 Guideline published and upload on stakeholder websites

Yes

e) Training of stakeholdersi) ToT to representative of all stakeholders

2015 – 2017 No. of ToT to representative of all stakeholders organised

2 ToT sessions

ii) Cascade training of the representative to the respective members

Percentage of respective members being trained

70%

f) Conduct a feasibility study to establish a national database of medicine availability

2015(to revisit at

midterm review)

Feasibility study done

Yes APHM, MPS, MOH, Association of Private Medical Practitioners, MCPG


Strategy 2: Distribution and Storage of Medicines


1. To review shorter delivery lead time of tender drugs (not more than 21 days)

2015 MOH

a) To get baseline ratio based on existing central contract items based on delivery lead time (A=≤ 21 days, B=22-30 days, C=>30 days)

2014-2015 Baseline done(Ratio of each

category) (A:B:C)

Yes

b) Periodic tracking to identify the root cause for non-compliance

2014-2015 Percentage of root causes identified

100%

2. Establish an ICT system to support the supply chain network:• Public (MOH)- Pharmacy Information System/ Clinic Pharmacy System

Pilot 2014 Roll out 2016

PhIS/CPS rolled out nationwide according to schedule as stated in the concession agreement

Nationwide implementation of PhIS/CPS to be completed in 2016

MOH, Pharmaniaga

Strategy 3: Disposal of Medicines


1. To establish Pharmaceutical Waste Disposal Guidelines APHM, MPS, MOH (PSD, Bahagian Engineering), Association of Private Medical Practitioners, MCPG, DoE

a) Form a committee 2014 Committee formed Yes

b) Conduct workshop(s) to establish specific guideline for pharmaceutical waste disposal in: - Public hospitals - Private hospitals - GPs - Community pharmacies (with reference to EQA 1974)

2014 – 2015 Guidelines drafted Yes

c) Dissemination of guidelines to all stakeholders

2016 Guidelines disseminated

2016


Strategy 4: Medicines Supply in Emergency Situations and Medicines Donations


1. To establish Medicines Donations Guideline MOH (PSD, Bahagian Pembangunan Kesihatan Keluarga, Bahagian Kawalan Penyakit), MERCY, MOD, PhAMA, MOPI, MAPS

a) Review the first draft 2014 Draft of guidelines to be reviewed and endorsed

2014

b) Endorse the revised guideline

2014

c) Publication of the guideline

2015 Guidelines published Yes

AFFORDABILITY OF MEDICINES

A) NATIONAL PRICING REFERENCE FOR MEDICINES


1. To develop National Pricing Reference for Medicines based on Recommended Retail Price (RRP)

2015 – 2017 Percentage of medicine with price in the National Medicine Formulary at the point of time (NMF based on commercially finished product available in the market)

2015 (70%) 2017 (80%)

MOH (PSD), MAPS, MOPI and PhAMA

Strategy 1: Transparency on Price Information


1. Development of a medicines price database• Medicines Price Database shall be developed

2015 e-PHU (e- Pangkalan Harga Ubat/ electronic Drug Price Database) system is fully operational

Yes PSD

2. The availability of RRP for public access• Compulsory price reporting for RRP

2014 Percentage of registered products with RRP (controlled medicines and OTC products only)

2015 (70%) MOH, PhAMA, MOPI, MAPS and all other distributor/ manufacturers in Malaysia



3. Compulsory itemised billing indicating the price of each item bought or supplied at all dispensing channels

PSD, FOMCA, School of Pharmacy, Discipline of Social and Administrative Pharmacy, USM and CAP

a) To collaborate with relevant stakeholders in raising awareness on itemised billing of medicines

2014 Pre-survey Pre-survey:End of 2014

Post survey on awareness of itemised billing in collaboration with School of Pharmacy, Discipline of Social and Administrative Pharmacy, USM

Post-survey: 2016

b) Implementation of itemised billing for medicines by all dispensing channels

2015 Compliance rate among prescribing channels

2016 (70%)

Strategy 2: Monitoring of Price Information


1. To compare medicine wholesale price at local market with International Reference Price MSH/ WHO

2013 – 2017 Annual Price Analysis & Comparison report

Once per year

PSD, PhAMA, MOPI, MAPS

2. To collaborate with WHO in the creation of an ASEAN price database

2014 – 2015 ASEAN price database developed

2015 MOH, WHO and others

Strategy 3: Tariffs and Duties


1. Continue to be exempted even with introduction of new tariffs

On-going Tariffs and duties on medicine

No tariffs and duties on medicine

MOH (PSD), MAPS, MOPI and PhAMA


B) FINANCING FOR MEDICINES


1. To propose drug tariff reimbursement mechanism based on National Medicine Formulary

2014 - 2017 Drug Tariff reimbursement proposal developed

Yes MOH, PhAMA, MOPI, MAPS, FOMCA, CAP, health economist and other relevant stakeholders

2. To propose reimbursement list for claims made through public coverage (e.g. e-MASS) and other payers

2017 Reimbursement list developed

Yes MOH ( PSD, National Health Financing Unit (NHFU), JPA , MOF, LIAM, MTA, NIAM

C) GENERIC MEDICINES POLICY

Strategy 1: Prescribing in generic International Non-proprietary Name (INN)


1. Generic Prescribing Survey (for government setting only)

Survey by 2014 Survey completed Yes MOH, MPS, Unit Kawalan Amalan

2. Generic Medicine Awareness Program (GMAP) nationwide Perubatan (UKAP), MMA, APHM, Federation of Private Medical Practitioners Association of Malaysia

i) Healthcare providers 2014 No. of seminars organised

1 seminar each state

ii) Consumers 2015-2017 Number of CME conducted

TBD

3. Generic prescribing to be enforced in new pharmacy law

Subject to the enactment of the new pharmacy law


Strategy 2: Procurement of all medicines by generic INN


1. Conduct a baseline survey that selection of medicine is made using generic name, i.e. quotations are made in generic name in all hospitals

2014 Survey conducted Yes MOH, APHM, MOE, MOD

Strategy 3: Selection for procurement in generic INN


1. Annual monitoring and analysis of uptake volume of import generics vs. local generics based on the information by data provider

2014 Data is available Yes MOH, MOPI & IMS

Strategy 4: Generic Labelling Practice


1. Carry out a study on generic labelling practice among GPs, retail pharmacy, hospitals and community clinics

2015 Survey findings are available by timeline

Yes MOH/ Enforcement

Strategy 5: Interchangeable and Non-interchangeable Medicines


1. Development of non-interchangeable medicines list

2016 List of non-interchangeable medicine to be endorsed

List to be endorsed by 2015

MOH, MPS, MMA, APHM, MOE, MOD


Strategy 6: Generic Medicine Substitution For All Interchangeable Medicines


1. Generic substitution except for non-interchangeable medicine to be enforced in new pharmacy law

After the enactment of the Pharmacy Law

Provision in law to allow for generic substitution

Yes NGO, Consumer Association, MOH, MPS, MMA, APHM, UKAP, FPMPAM2. Raise awareness of the

new Pharmacy Law(Public engagement through NGOs and Consumer Association)

After the enactment of the Pharmacy Law

Strategy 7: Appropriate incentives to promote the use of generic medicines and their production in the country


1. Expand the scope of GMAP to collaborate with other agencies to conduct activities that promote the use of generic medicines among consumers

2014 - 2015 No. of collaboration with other agencies

At least one collaboration activity organised

MOH, MPS, APHM, FPMPAM, consumer associations


4. QUALITY USE OF MEDICINES


4. QUALITY USE OF MEDICINES

POLICYQuality use of medicines is the responsibility of all stakeholders. Activities by relevant stakeholders in support of informed and appropriate use of medicines shall be encouraged and promoted.

AIM

• To ensure medicines are used judiciously, appropriately, safely and cost-effectively towards promoting better health outcomes.

STRATEGY The aim shall be achieved through:

• Development and implementation of models of best practice

• Education and training

• Provision of timely and accurate information on medicines

• Strengthening seamless care between public and private health care providers

• Research and development in quality use of medicines

• Engagement of payers involved in reimbursements for medicines use


DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE


1. Identify existing pharmaceutical care activities for the private sector & non-MOH hospitals

2014 Survey done Yes MOH, MOE, MOD, MPS, APHM & relevant professional associations

2. Strengthen the involvement of pharmacists in the wards (medical & critical care)

On-going a) Percentage of MOH hospitals with pharmacist involvement in the wards

All MOH, MOE, MOD, MPS, APHM & relevant professional associations

On-going b) Percentage of non-MOH hospitals with pharmacist involvement in the wards

TBD (To get

baseline from

survey)

On-going c) Percentage of private hospitals with pharmacist involvement in the wards

TBD

3. Strengthen the involvement of pharmacists in ambulatory care – counselling

On-going a) Number of MOH facilities with pharmacists providing counselling

All MOH, MOE, MOD, MPS, APHM & relevant professional associationsOn-going b) Number of

Community Pharmacies providing counselling

TBD

On-going c) Number of private & non-MOH hospitals providing counselling

TBD



4. Strengthen the involvement of pharmacists in ambulatory care for chronic disease management – Medication Therapy Adherence Clinic (MTAC)

On-going a) Number of MOH facilities with pharmacists providing MTAC

All MOH, MOE, MOD, MPS, APHM & relevant professional associationsOn-going b) Number of

Community Pharmacies providing MTAC

TBD

On-going c) Number of private & non-MOH hospitals providing MTAC

TBD

5. Strengthening of Home Medication Review (HMR) activities in MOH facilities

On-going Number of facilities providing HMR services

Increasing trend

MOH

6. To conduct medication safety activities

On-going a) Number of hospitals with patient safety committees

Increasing trend

MOH

On-going b) Number of hospitals with medication safety activities

Increasing trend

7. To conduct antibiotic utilisation surveillance

2014 – 2015 Number of facilities Increasing trend

MOH, MOE, MOD, MPS, APHM & relevant professional associations

EDUCATION AND TRAINING

Strategy 1: Healthcare Providers


1. Establishment of training centres with best practice in medical, critical care & MTAC

On-going Number of training centres

2 training centres for each speciality

MOH

2. Training of pharmacists in medical, critical care & MTAC

On-going Number of pharmacists trained

Increasing trend


Strategy 2: Consumers


1. Carry out projects and campaigns in collaboration with pharmacies / universities / MPS / NGOs to educate the public on the quality use of medicines

On-going a) Number of projects

1 project per year

MOH, Universities, NGOs, MPS, Community Pharmacies

On-going b) Incremental increase in level of knowledge and awareness

65% in 2015(Increment by 20% from baseline)

On-going c) Number of activities carried out by the private sector (community & hospital pharmacies)

Increasing trend

2. Carry out projects and campaigns for primary and secondary schools to educate students on the quality use of medicines

On-going a) Percentage of primary schools covered by projects and campaign

30% (2015) MOH, MOE

On-going b) Percentage of secondary schools covered by projects and campaigns

Increasing trend (From baseline in 2014)

3. Training of community leaders on the quality use of medicines through workshops

On-going Number of ToT sessions

8 ToT sessions per year

MOH

4. Educating specific target group by providing medication counselling & through medication therapy adherence clinics (MTAC)

On-going Percentage of MTAC diabetes patients who adhere to their medicines

Increasing trend

MOH

Strategy 3: Pharmaceutical Industry


1. Covered under Component 1 (Governance in Medicines)


Strategy 4: Media


1. Seminar / dialogue on QUM concept and appropriate reporting aimed towards media personnel

On-going Number of seminars organised

1 training per year

MOH, Malaysian Communication & Multimedia Commission (MCMC), Reporters

PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES

Strategy 1: Healthcare Providers


1. Rebranding & enhancing the role of the National Pharmacy Call Centre (NPCC)

2015 Number of publications of information on new drugs

Increasing trend

MOH

Strategy 2: Consumers


1. Promoting available access to medicine information (e.g., NPCC, Drug Info Committees (DIC) in hospitals, Know Your Medicine portal, MyHealth portal)

On-going Number of consumers seeking information from available information resources

Increasing trend

MOH

2. Dissemination of information to the general public through mass media, educational material and social media

On-going Number of topics disseminated

10 topics per year

Strategy 3: Pharmaceutical Industry


1. Monitoring adherence to Medicines Advertising guidelines

On-going Percentage of compliance

100% PhAMA, MOPI, MAPS & other industry players


Strategy 4: Media


1. Develop guidelines on the responsible reporting on medicines by the media

2015-2017 Guidelines developed

Yes MOH, media

2. Screening & prompt response to misinformation in the media

On-going Percentage of responses delivered to the media within 24 hours

100%

STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE PROVIDERS


1. Provide comprehensive medication management system to improve monitoring of drug usage

2015 Percentage of identified facilities using Pharmacy Information System (PhIS)

100% MOH

RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES


1. Covered under Component 5 (Partnership & Collaboration for the Healthcare Industry)



5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY


5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY

POLICYPartnerships and collaboration in the implementation and strengthening of relevant areas in the healthcare industry shall be established among various stakeholders at the national, regional and international levels.

AIM

• To ensure that partnership and collaboration of all relevant stakeholders in the healthcare industry conforms to the best practices and standards pertaining to medicines at the national, regional and international levels.

STRATEGYThe aim shall be achieved by:

• Early and continuous engagement of all relevant stakeholders (Human Resource Development)

• Ensuring sustainability of qualified, competent and effective human resource based on needs through (Research and Development)

o Training and development

o Development and advancement of professional career pathway

• Sharing of information, expertise, skills and facilities (Technical Collaboration and Partnership)

• Developing a viable domestic and maintaining a responsible medicines industry (A viable and Responsible Pharmaceutical Industry)


HUMAN RESOURCE DEVELOPMENT


1. Incorporate DUNas policy into curriculum

2015 Engagement with MOE

Yes Pharmacy Board/ AKEPT/ Universities/ CollegesAgreement

from MOE for incorporation

Yes

2. Incorporation of DUNas policy as a compulsory module in the healthcare professional programmes

2017 Number of healthcare professional programmes incorporating DUNas policy as a compulsory module

All healthcare programs

Pharmacy Board/ Regulatory bodies/ Professional Associations/ Universities / Colleges

3. Implementation of DUNas online module in CPD programme

2015 – 2017 Number of health professionals passing the module

Increasing trend

Pharmacy Board / MPS/ MAP

4. Identify career opportunity and development for both private and public sector

2014 Career pathways determined for different industries

Yes Pharmacy Board, MAP, all stakeholders

5. Development of a structure for specialisation and recognition

2014 – 2017 Number of areas of specialisation identified

TBD Pharmacy Board, MAP, all stakeholders

Structure for recognition developed

Yes

RESEARCH AND DEVELOPMENT


1. Identify priority areas to create incentives to attract more local and international R&D initiatives in Malaysia

2015-2017 Set criteria and incentives for drug utilisation & management

Yes NPCB, PhAMA, PEMANDU, CROs, CRM, CRC, MOPI, MOSTI, MOF, MIDA, Universities, etc.

2015-2017 Number of eligible research projects for incentives

3 projects


TECHNICAL COLLABORATION AND PARTNERSHIP


1. Identify areas and implement technical collaboration: Government agencies and private sectors, universities

a) Regulatory Practice 2015 No of MoUs with other countries

Yes

b) Market access (MOH, academy, industry)

2015 Number of health economic studies on utilisation of drugs

Yes

A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY

Strategy 1: Domestic Pharmaceutical Manufacturing


1. Amendment on Patent Act (Acceptance of recommendations of the *I-Cells Study in 2011)

By 1st quarter of 2014

Paper tabled in the cabinet

Yes PEMANDU, Bahagian Dasar & Hubungan Antarabangsa, MOH

2. PEMANDU to work with MyIPO to:a) Build capacity & capability to provide timely filing of patents & accurate data for stakeholders

On-going Updated and current patent information data

Yes MyIPO, PEMANDU, Bahagian Dasar & Hubungan Antarabangsa, MOH, NPCB, MOPI, PhAMAb) Provide accurate

database information for users to track

On-going Timely patent filing Yes

3. Implementation of the off-take agreement

2013 - 2017 Number of off-take agreement

To be determined (based on consent from MOF)

MOF, Bahagian Dasar & Hubungan Antarabangsa, MOH, Bahagian Perolehan & Penswastaan MOH, NPCB MOH, PEMANDU, MIDA, MOPI

Number of products exported

*A Study on issues related to the Patent Law and Policy in Malaysia in relations to the domestic Pharmaceutical Industry


LIST OF ORGANISING COMMITTEE MEMBERS

ChairmanDr. Nour Hanah binti Othman

Deputy Director (Pharmacy Policy & Management)Pharmaceutical Services Division

Organising CommitteeMs. Siti Aida binti AbdullahDeputy Director of Centre of Organisation DevelopmentNational Pharmaceutical Control Bureau

Ms. Anis binti TalibDeputy Director of Formulary & Pharmacoeconomic UnitPharmaceutical Services Division

Ms. Faridah binti Abdul MalekDeputy Director of Pharmaceutical Logistics UnitPharmaceutical Services Division

Ms. Salbiah binti Mohd SallehDeputy Director of Medicine Price UnitPharmaceutical Services Division

Ms. Abida Haq binti Syed M. HaqChief Pharmacist Hospital Kuala Lumpur

Ms. Hasnizan binti HasanSenior Principal Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Ms. Sarah NagalingamPrincipal Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Ms. Phuar Hsiao LingSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Ms. Nor Yati binti ZolkopriSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Ms. Melanie binti HassimSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Ms. Lau Ling WeiSenior Assistant Director National Medicine Policy Section (DUNas)Pharmaceutical Services Division

Mr. Khairul Iman bin MuzakirSenior Assistant Director Pharmaceutical Services Division

Mr. Muhamad Azlan bin BashirunSenior Assistant Director Pharmaceutical Services Division

Ms. Nur Azhana binti AbdullahSenior Assistant Director Pharmaceutical Services Division

Ms. Siti Fairuz binti Zulkefeli Senior Assistant Director Pharmaceutical Services Division

Mr. Ahmad Syafique bin Mohd SukarnoTechnicianPharmaceutical Services Division

Ms. Rosemah Shaik Ali@Sheikh HasanAdministrative AssistantPharmaceutical Services Division

Ms. Nur Syafira binti UzairiAdministrative AssistantPharmaceutical Services Division


PANEL DISCUSSION MEMBERS

Dato’ Eisah binti A. RahmanSenior Director of Pharmaceutical Services

Ministry of Health, Malaysia

Mr. Mohd Hatta bin AhmadDirector of Pharmacy Enforcement Division


Dr. Salmah binti BahriDirector of Pharmacy Practice and Development Division


Mr. Tan Ann LingDirector of National Pharmaceutical Control Bureau


Mr. Yew Wei TarngPresident

Pharmaceutical Association of Malaysia, (PhAMA)

Mr. Leonard Ariff bin Abdul ShatarPresident

Malaysian Organization of Pharmaceutical Industries, (MOPI)

Mr. John ChangMalaysian Pharmaceutical Society (MPS)


LIST OF PARTICIPANTSComponent 1 & 5:

Governance in Medicines & Partnership and Collaboration in the Healthcare Industry

• Group Leader : Dr. Nour Hanah Othman Deputy Director, U54 Pharmacy Policy and Management, MOH

Attendees :

No. Name Designation Stakeholder/ Agency/ Organization Representative

1 Azman Yahya Deputy Director, U54 Pharmacy Board, MOH

2 Siti Fauziah Abu Senior Principal Assistant Director, U52

Pharmacy Practice & Development, MOH

3 Salina Mohd Zamani Senior Principal Assistant Director, U52

Pharmacy Enforcement, MOH

4 Leona Tan Sze Ping Principal Assistant Director, U48


5 Yusri Razalli @ Ghazali

Chief Senior Assistant Secretary

Bahagian Sumber Manusia, MOH

6 Lim Shean Lee Chief Assistant Secretary Bahagian Dasar & Hubungan Antarabangsa, MOH

7 Jong Koi Chong Assistant Secretary Bahagian Pengurusan Latihan, MOH

8 Prof. Dr. Mohamed Mansor Manan

Lecturer Universiti Teknologi MARA (UiTM)

9 Dr. Syed Ibrahim Mohd Ismail

Chief Executive Officer Malaysian Organization of Pharmaceutical Industries (MOPI)

10 Ewe Kheng Huat Executive Director Pharmaceutical Association of Malaysia (PhAMA)

11 Shamsuri Kadir Head of Public Affairs & Market Access

Pharmaceutical Association of Malaysia (PhAMA)

12 Prof. Madya Dr. M. Haniki Nik Mohamed

Principal, Malaysian Academy of Pharmacy & Head, Pharmacy Practice Department

Kulliyyah of Pharmacy, International Islamic University Malaysia (IIUM)

13 Haniza Anom Hashim Vice President, Legal & Regulatory, Strategy & Planning

Malaysian Biotechnology Corporation Sdn. Bhd.

14 Dr. Nik Musa’adah Mustapa

Senior Research Officer Forest Research Institute Malaysia (FRIM)

15 Hamim Hamdan Mustafa

Senior Assistant Director Malaysian Investment Development Authority (MIDA)


Component 2: Quality, Safety and Efficacy of Medicines

• Group Leader : Puan Noorizam binti Ibrahim Deputy Director, U54 National Pharmaceutical Control Bureau (NPCB)

Attendees :


1 Siti Aida Abdullah Deputy Director, U54 National Pharmaceutical Control Bureau (NPCB)

2 Mohd Zulkifli Abdul Latif

Deputy Director, U54 Pharmacy Enforcement, MOH

3 Ahmad Zakhi Ramli Senior Principal Assistant Director, U54


4 Azraini Abdul Samat Senior Principal Assistant Director, U52

National Pharmaceutical Control Bureau (NPCB)

5 Somiyaton Mohd Dahalan

Senior Principal Assistant Director, U52


6 Rohaida Zakaria Senior Principal Assistant Director, U52


7 Nurhayati Othman Senior Principal Assistant Director, U52


8 Norleen Mohamad Ali Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)

9 Fazillahnor Ab Rahim Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)

10 Manzatul Azrul Azrie Sulaiman

Principal Assistant Director, U48 Pharmacy Enforcement, MOH

11 Tee Khim Boon Senior Assistant Director, U44 National Pharmaceutical Control Bureau (NPCB)

12 Nor Yati Zolkopri Senior Assistant Director, U44 Pharmacy Policy and Management, MOH

13 Sabrina Haron Regulatory Affairs, Manager 1/ Pharmacist

CCM Duopharma Biotech Bhd.(represents MOPI)

14 Sumitha Ganasegaram

Regulatory Affairs Director GlaxoSmithKline Pharmaceutical (represents PhAMA)

15 J. S. Sunitha Dewi Regulatory Affairs Director GlaxoSmithKline Consumer Healthcare S/B (represents PhAMA)

16 Alice Chee Seat Mee Regulatory Consultant Pharmaceutical Association of Malaysia (PhAMA)

17 Lam Kai Kun General Manager Malaysian Pharmaceutical Society (MPS)

18 Zarrah Banu Hulwani Abdul Rahim

Technical & Regulatory Manager Amway (Malaysia) Sdn. Bhd. (represents DSAM)


Generic Medicine Awareness Program (GMAP) nationwide

Component 3: Access to Medicines (Availability)

• Group Leader : Puan Anis binti Talib Deputy Director, U54 Pharmacy Practice & Development, MOH

Attendees :


1 Faridah Abdul Malek Deputy Director, U54 Pharmacy Practice & Development, MOH

2 Dr. Faridah Aryani Md. Yusof

Senior Principal Assistant Director, U54


3 Norhaliza A. Halim Senior Principal Assistant Director, U54


4 Azuwana Supian Senior Principal Assistant Director, U54


5 Dr. Mona Zaria Nasaruddin

Medical Specialist Institute of Respiratory Medicine, Hospital Kuala Lumpur

6 Rosliza Lajis Senior Principal Assistant Director, U52


7 Sarawani Hassan Principal Assistant Director, U48 National Pharmaceutical Control Bureau (NPCB)

8 Lau Ling Wei Senior Assistant Director, U44 Pharmacy Policy & Management, MOH

9 Hisyam Yong Abdullah

Chief Assistant Secretary Bahagian Perolehan & Penswastaan, MOH

10 Wong Kuan Yeen Senior Assistant Director, U44 Bahagian Perubatan Tradisional & Komplementari, MOH

11 Safina Zainal Principal Assistant Director Jabatan Kemajuan Islam Malaysia (JAKIM)

12 Taqwa Zabidi Assistant Director Jabatan Kemajuan Islam Malaysia (JAKIM)

13 Aileen Chong General Manager, Vitacare Pharmacy

Malaysian Pharmaceutical Society (MPS)

14 Dr. Mohd Ilham Adenan

Senior Research Officer Forest Research Institute Malaysia (FRIM)

15 Lee Seng Dee Chief Pharmacist Pantai Holdings Berhad (represents APHM)

16 Stephanie Koh Market Access Manager Pharmaceutical Association of Malaysia (PhAMA)

17 Lily Lee MSO KAM & Market Access Head Pharmaceutical Association of Malaysia (PhAMA)

18 Henri Antaki Business Unit Director Pharmaceutical Association of Malaysia (PhAMA)

19 Masniza Mustaffa Health Coordinator MERCY Malaysia

20 Lee Xui Kin Registration Manager Malaysian Organization of Pharmaceutical Industries (MOPI)


Component 3: Access to Medicines (Affordability)

• Group Leader : Puan Salbiah binti Mohd Salleh Deputy Director, U54 Pharmacy Practice & Development, MOH

Attendees :


1 Fatimah Abdul Rahim Senior Principal Assistant Director, U54


2 Saimah Mat Noor Senior Principal Assistant Director, U54


3 Fatkhiah Hj. Khalil Senior Principal Assistant Director, U54


4 Hasnizan Hasan Senior Principal Assistant Director, U54

Pharmacy Policy and Management, MOH

5 Rosilawati Ahmad Senior Principal Assistant Director, U54


6 Melanie Hassim Senior Assistant Director, U44 Pharmacy Policy and Management, MOH

7 Amrahi Buang Chief Pharmacist University Malaya Medical Centre (UMMC)

8 Ng Su Yee Chief Manufacturing & Technical Officer

CCM Pharmaceuticals Sdn. Bhd. (represents MOPI)

9 Rohan Talalla Head, Corporate & Government Affairs

GlaxoSmithKline Pharmaceuticals (represents PhAMA)

10 Kathleen Yeoh Head of Market Access & Patient Relation

Abbvie Sdn. Bhd. (represents PhAMA)

11 Noor Yang Azwar Kamarudin

Public Affairs & Communication Director

Pfizer (M) Sdn. Bhd. (represents PhAMA)

12 Hong Li Wen Manager Market Access Pfizer (M) Sdn. Bhd. (represents PhAMA)

13 John Chang Deputy President Malaysian Pharmaceutical Society (MPS)

14 Dr. Steven Chow Kim Weng

President Federation of Private Medical Practitioners’ Associations Malaysia (FPMPAM)

15 Zainal Abidin Lajat Manager KPJ Healthcare Berhad (represents APHM)

16 Dr. Choe Tong Seng Executive Director Malaysian Association of Pharmaceutical Suppliers (MAPS)

17 Ang Khoon Lim Managing Director, Pharm D. Sdn. Bhd.

Malaysian Association of Pharmaceutical Suppliers (MAPS)

18 Renuga Muniandy Pharmacist, KPJ Healthcare Bhd. Association of Private Hospitals of Malaysia (APHM)

19 Dr. T. Jayabalan Advisor The Consumers Association of Penang (CAP)


Component 4: Quality Use of Medicines

• Group Leader : Puan Rosminah binti Md Din Deputy Director, U54 Pharmacy Practice & Development, MOH

Attendees :


1 Rosminah Md. Din Deputy Director, U54 Pharmacy Practice & Development, MOH

2 Che Pun Bujang Deputy Director, U54 Pharmacy Practice & Development, MOH

3 Fuziah Abd. Rashid Senior Principal Assistant Director, U54


4 Mazlan Ismail Senior Principal Assistant Director, U54


5 Dr. Siti Norlina Md. Said Chief Pharmacist, U54 Hospital Sultanah Aminah, Johor Bahru

6 Abida Haq Syed M. Haq Chief Pharmacist, U54 Hospital Kuala Lumpur

7 Normawati Muhammad Chief Pharmacist, U54 Hospital Tengku Ampuan Rahimah, Klang

8 Haji Abdol Malek Abd Aziz

Chief Pharmacist Hospital Tuanku Ja’afar, Seremban

9 Kol. A. Halim Haji Basari Pengarah Farmasi Health Services Division of Malaysia Armed Force HQ, MOD

10 Dr. Samsuddeen Abd. Aziz

Ketua Unit Projek Khas Ministry of Education

11 Phuar Hsiao Ling Senior Assistant Director, U44 Pharmacy Policy and Management, MOH

12 Yusni Rizal Dato’ Khairul Anuar

General Manager Pharmaniaga LifeScience Sdn. Bhd. (represents MOPI)

13 Norhana Nawawi Suri Regulatory Affairs Manager, Servier Malaysia Sdn. Bhd.

Pharmaceutical Association of Malaysia (PhAMA)

14 Andy Lee Public Affairs Manager Pharmaceutical Association of Malaysia (PhAMA)

15 Richard Leong Business Unit Director Pharmaceutical Association of Malaysia (PhAMA)

16 Yip Sook Ying Pharmacist Farmasi Alychem Sdn. Bhd. (represents MPS)

17 Dr. Azizan Abdul Aziz Honorary General Treasurer Malaysian Medical Association (MMA)

18 Prof. Madya Dr. Chua Siew Siang

Senior Lecturer Pharmacy Department, Faculty of Medicine, University of Malaya


ABBREVIATIONS

ADR Adverse Drug ReactionAEFI Adverse Event Following ImmunisationAPHM Association of Private Hospitals MalaysiaAPI Active Pharmaceutical IngredientAPPL Approved Product Purchase ListASEAN The Association of Southeast Asian NationsBE BioequivalenceBIMST-EC Bay of Bengal Initiative for Multi Sectoral Technical and Economic CooperationBPP Bahagian Perkembangan Perubatan BPTK Bahagian Perubatan Tradisional dan KomplementariCD Compliance DataCMA Compliance Monitoring AuthorityCoC Code of ConductCPD Continuing Professional DevelopmentCPG Clinical Practice GuidelinesCRC Clinical Research CentreCRM Clinical Research MalaysiaCRO Contact Research OrganizationDCA Drug Control AuthorityDE Data ExclusivityDSAM Direct Selling Association of MalaysiaDUNas Dasar Ubat NasionalEDQM European Directorate for the Quality of MedicinesEQA Environmental Quality ActEU European UnionFPMPAM Federation of Private Medical Practioners’ Associations MalaysiaFRIM Forest Research Institute MalaysiaGCP Good Clinical PracticeGDP Good Distribution PracticeGGM Good Governance for MedicinesGLP Good Laboratory PracticeGMAP Generic Medicines Awareness ProgrammeGMP Good Manufacturing PracticeGSP Good Storage PracticeICSR Individual Case Safety ReportsICT Information and Communication TechnologyIMR Institute of Medical Research MalaysiaINN International Nonproprietary NamesIRP International Reference PriceJAKIM Jabatan Kemajuan Islam MalaysiaKPI Key Performance IndicatorLIAM Life Insurance Association of MalaysiaMAB Medicines Advertisement BoardMAD Mutual Acceptance DataMAP Malaysian Academy of PharmacyMAPS Malaysian Association of Pharmaceutical Suppliers


MCMC Malaysian Communications and Multimedia CommisionMCO Managed Care organisationMIDA Malaysian Investment Development AuthorityMOD Ministry of DefenceMOE Ministry of EducationMOF Ministry of FinanceMOH Ministry of HealthMOPI Malaysian Organisation of Pharmaceutical IndustriesMOSTI Ministry of Science, Technology & InnovationMoU Memorandum of UnderstandingMPR Median Price RatioMRDS Malaysian Rare Disorders SocietyMSH Management Sciences for HealthMTA Malaysian Takaful AssociationMTAC Medication Therapy Adherence ClinicMyIPO Intellectual Property Corporation of MalaysiaNCE New Chemical EntityNDRA National Drug Regulatory AuthorityNDTC National Drug & Therapeutic CommitteeNEML National Essential Medicine ListNIAM National Insurance Association of MalaysiaNMF National Medicine FormularyNPCB National Pharmaceutical Control BureauNPCC National Pharmacy Call CentreOECD Organisation for Economic Cooperation and DevelopmentOTC Over-the-counterPE PharmacoeconomicsPEMANDU Performance and Delivery Unit, JPMPhAMA Pharmaceutical Association of MalaysiaPhIS Pharmacy Information SystemPIC/S Pharmaceutical Inspection Co-operation SchemePMAS Post Marketing Surveillance Alert SystemPSD Pharmaceutical Services DivisionQC Quality ControlQUM-C Quality use of medicines – consumerRAS Rapid Alert SystemRRP Recommended Retail PriceSPOC Single Point of ContactSSFFC Substandard/ spurious/ falsely-labelled/ falsified/ counterfeitTCM Traditional and Complementary MedicineToT Training of TrainersTOR Term of ReferenceTWG Technical Working GroupUHC Universal Health CoverageWHO World Health OrganizationWHO/ HAI World Health Organization / Health Action InternationalWPRO World Health Organization Regional Office for the Western Pacific

Pharmaceutical Services DivisionMinistry of Health Malaysia

Lot 36, Jalan Universiti, 43650 Petaling Jaya, Selangor

Documents

MASTER PLAN OF ACTION - Bahagian Perkhidmatan · PDF fileaction for Malaysian National Medicines Policy 2nd Edition (2012): ... Pharmacists and medical doctors from public and private