TMMDA Turkish Medicines and Medical Devices Agency

TMMDA

Turkish Medicines and

Medical

Devices Agency

Marketing Authorization

Procedure

«FORUM for GENERIC DRUG»

Ali ALKAN, MD

Vice President

OUTLINE

2 Turkish Medicines and Medical Devices

Agency

About us

Turkey

Turkish Pharmaceutical Market

Turkish Medicines and Medical Devices Agency

Main Activities of the Agency

Marketing Authorization Procedure

TURKEY

3 Turkish Medicines and Medical Devices Agency

Population 79.814.871 as of December 31, 2016

Median Age 31.4

GDP Per Capita 10.807 USD

GDP Growth Rate %2.9

*Turkish Statistical Institute

Statistics*

WORLD PHARMACEUTICAL MARKET


The world pharmaceutical market reached 1.10 trillion USD in 2016. Turkey ranked

16th in 2016.

Source: IMS

462

117 90 43 32 29 27 27 21 19 17 14 13 12 9 7 7 6 6 6

050

100150200250300350400450500

USD $ (Bn)

16.

TURKISH PHARMACEUTICAL MARKET


The Turkish pharmaceutical market reached 21,4 billion Turkish Liras (TL) in 2016. Unit

sales reached 2.20 billion units.

Box (billion) TL (billion)

Source: IMS

0.72 0.81

0.9

1.28 1.36

1.48 1.57 1.61

1.67

1.85 1.89 1.91 1.97

2.11 2.2

0

0.5

1

1.5

2

2.5

0

5

10

15

20

25

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

TURKISH PHARMACEUTICAL MARKET


88 Pharmaceutical Production Facilities

10 Raw Material Production Facilities

21,4 Billion TL (≈7 billion USD $)Total Pharmaceutical Market

TMMDA


Pharmacist 324 Health Inspectors and Trainees

32

Product Audit andAssociate 83 Engineer 86

Chemist 69 Medical Doctor 35

Biologist 58 Others 328

ORGANISATION CHART


President

Vice Presidency of Medicines

and Pharmacy

Vice Presidency of Inspectorate

Vice Presidency of Medical

Devices and Cosmetics

Vice Presidency of Economic Assessments

and Laboratory Services

Vice Presidency of Support and

Information Management

Department of Legal

Consultancy

Department of Strategy

Development

MISSION


Quality, efficacy and

safety

The highest standart of public health protection

Ensure the access of product groups

Regulation, evaluation, monitoring

Med. Devices

MARKETING AUTHORIZATION

PROCEDURE

1. Legal Basis - Regulations

2. Marketing Authorization Department

3. Marketing Authorization Process

4. Marketing Authorization Change Management

5. Marketing Authorization - Numbers

ORGANISATION CHART


VIC

E P

RES

IDEN

CY

OF

MED

ICIN

ES A

ND

P

HA

RM

AC

Y

DEPARTMENT OF MEDICINES MARKETING AUTHORIZATION

DEPARTMENT OF CLINICAL TRIALS

DEPARTMENT OF HERBAL AND SUPPORT PRODUCTS

DEPARTMENT OF PHARMACOVIGILANCE AND CONTROLLED SUBSTANCES

DEPARTMENT OF PHARMACIES

DEPARTMENT OF MEDICINES MARKETING AUTHORIZATION


•Pharmacist : 105

•Biologist: 10

•Others: 19

•Master Degree: 84

•PhD Degree: 10

134

OCCUPATIONAL GROUPS and EDUCATIONAL LEVELS

LEGAL BASIS


• Pharmaceutics and Medicinal Product Law (Law No : 1262 (Publication Date in the Official Gazette : 26th May, 1928 Issue No. 898) :

«the competent authority for registering human medicinal products in Turkey, is Ministry of Health»

«any medicinal product can not be placed on the market, unless a marketing authorization has been

issued by Ministry of Health of Turkey»

• Decree Law No. 663 of 2011:

«Ministry of Health is using this authority with Turkish Medicines and Medical Devices Agency (TMMDA), which is affiliated to Ministry of Health.»

• Regulation on the Marketing Authorization of Medicinal Products for Human Use

(Official Gazette dated January 19, 2005 / Issue No.25705) :

The registration transactions conducted by our Agency are performed in line with the provisions of the

“Regulation on the Marketing Authorization of Medicinal Products for Human Use” which was regulated according to Directive 2001/83/EC , is the basic Regulation for Marketing Authorization.

http://www.titck.gov.tr/%C4%B0la%C3%A7/%C4%B0la%C3%A7taRuhsatland%C4%B1rma

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF



REGULATIONS


EU Harmonization - We follow the EMA and ICH scientific guidelines

Human Medicinal Products Registration Regulation

BA/BE Regulation

Variation Regulation

Biosimilar Regulation are updated.

Many of our regulations have been updated according to the EU

AN OVERVIEW OF THE REGISTRATION


Pre- Assessment

Scientific Assessment

LICENSE Administrative Assessment

MARKETING AUTHORIZATION PROCESS / Pre-Assessment


After the dossier is submitted to the Agency, it is evaluated in 30 days and the applicant is informed about the decision.

If the submission is found to be inadequate the applicant has to complete the deficiencies in 30 days.

Like in the first step, in the second preassessment step the revised dossier is evaluated in 30 days, as well.

If the dossier is still lack of necessary information the application is rejected by the Agency.

Pre-Assessment


Pre-assessment contains, assessment of documents which are prepared accordingly Common Technical Documents (CTD) format, determined by International Conference of Harmonization (ICH) and an international standard.

Registration applications are submitted in Common

Technical Document (CTD) format since 2005 in Turkey.

CTD applications have been accepted electronically since 2011.

e-CTD transition studies are being carried out

MARKETING AUTHORIZATION PROCESS



Manufacturing place must have a valid GMP certificate issued by the Agency to the manufacturer, indicating that the manufacturer is capable of carrying out manufacturing operations in line with the Good Manufacturing Practices.

Before submission, the applicant must apply to the Agency for GMP inspection and submit the relevant data in a dossier.

This GMP certificate must be in the registration application dossier.

If the product which is applicant for authorization has high priority, it can be submitted without GMP certificate and the certificate can be presented during period of authorization.

Application to PIC/S (May 2013) : Our application for the PIC/S membership is in the evaluation phase. We had an assessment at the beginning of this year. The missing minor deficiencies were removed. At the end of the year, we expect our membership to be approved.

MARKETING AUTHORIZATION PROCESS-GMP Inspectıons

MARKETING AUTHORIZATION PROCESS-GMP Inspectıons


GMP Prioritisation Applications can be made before the GMP Inspection Aplications or simultaneously. (GMP 1, 2, 3)

According to decision of Prioritisation Assessing Authority, GMP inspection is carried out.

Conventional products

Biotechnological products

2. GMP for active substance it is acceptable approval of other authorities

1. GMP for finished product must be issued by TMMDA

3. GMP 1 is only for finished product: Application is acceptable without GMP certification.

2. GMP 1 is for finished product and active substance: Application is acceptable without GMP certification.

1. GMP for finished product and active substance must be issued by us





SCIENTIFIC ADVISORY COMMISSIONS


• Councils of Technological Assessment (2)

• Council of Technological Assessment for Registered Products (1)

Internal Commisions

(3 commisions

12 members*)

• Clinical Assessment (1)

• Technological Assessment (7)

• Radiof./Radioopak Products Assessment (1)

• Biological Products Assessment (2)

• Biotechnological Products Assessment (2)

• BA/BE Assessment (2)

• Pharmacological Assessment (2)

Commissions

(17 commissions, 45 of the 180 members are

from our Agency)

*Personnel of the Agency

MARKETING AUTHORIZATION FEES


TMMDA PRICE TARIFF - 2017

TL ≈ US $

Application for imported medicine 3.115,00 879

Application for local produced medicine 2.077,00 586

Scientific Examination and Evaluation Fee (import-new medicines)

40.000,00 11.299

Scientific Examination and Evaluation Fee (import-generic medicines)

30.000,00 8.474

Scientific Examination and Evaluation Fee (local) 20.000,00 5.649

License (import) 3.115,00 879

License (local) 2.077,00 586

PRIORITIZATION-1


* Time of registration is 150 days. ** Time of registration is 180 days. *** Time of registration is 210 days.

Prioritization

1. HIGH PRIORITY

2. PRIORITY

3. NORMAL

PRIORITIZATION-2

26

The distribution ratio of the products which were assessed between the dates 17 of February 2016 and 15 of December 2016 is as follows;

High Priority Decision for 212 products

Priority Decision for 358 products

Reject Decision for 237 products

Reject of Objection Decision for 4 products which have been re-assessed.

4 REJECT OF OBJECTION

212 HIGH PRIORITY

358 PRIORITY 811 237

REJECTED

Turkish Medicines and Medical Devices Agency

SLOT IMPLEMENTATION


Pre-Assessment Number of

application acc to capacity

Time of application acc to application type

Scientific Assessment

(Application)

There are no pending applications at the present time

NUMBERS of 2016 - 1


2016

GENERIC MEDICINE

IMPORTED 23

LOCAL PRODUCTION 345

TOTAL 368

NEW MEDICINE

IMPORTED

79

LOCAL PRODUCTION 152

TOTAL 231

GRAND TOTAL 599

NUMBER OF THE LICENSE APPLICATIONS-Conventional Medicines

NUMBER OF THE REGISTRATED MEDICINES-Conventional Medicines 2016

GENERIC MEDICINE

IMPORTED 28

LOCAL PRODUCTION 411 TOTAL 439

NEW MEDICINE

IMPORTED

53

LOCAL PRODUCTION 68

TOTAL 121 GRAND TOTAL 560

NUMBERS of 2016 - 2


2016

BİOLOGICAL-BİOTECHNOLOGICAL

IMPORTED 44

LOCAL PRODUCTION 16

TOTAL 60

NUMBER OF THE LICENSE APPLICATIONS-Biological/Biotechnological products

NUMBER OF THE REGISTRATED MEDICINES-Biological/Biotechnological products

2016

BİOLOGICAL-BİOTECHNOLOGICAL

IMPORTED 43

LOCAL PRODUCTION 4

TOTAL 47

Some important issues


Agency

A medicinal product which is not registered by our Agency shall

not be placed on the market.

Real persons or legal entities located within the borders of

Turkey shall be obliged to prepare for each pharmaceutical

form.

Patent issues are not among our tasks, so there is no need to

patent certification for pharmaceutical products.

We do not have a standard approach about «race» in clinical

trials. According to the characteristics of the product, clinical

trials are conducted with local people or bridge studies can be

required. Especially, if the trial is conducted only one race or

only vegetarian population, we have a cautios approach to

these trials.

Summary


Agency

With all these explanations;

• For providing quality, safety and efficacy of the products, as a

competent authority, TMMDA serves to human health with

applying regulatory, controller and leader policies for human

medicinal products.

• We have a well-functioning regulatory system that respects the

predicted registration time per product.

• The pharmaceutical industry should be confident that we are an

agency that communicates openly with them. We are always open

to discuss about applications made, with scientific point of view.

Reference Pricing System


Agency

Legislations

Decision On The Pricing Of Medicinal Products For Human Use (24.02.2017) Notification On The Pricing Of Medicinal Products For Human Use (11.12.2015) (uptading)



Agency

Reference pricing system-since 2004.

Lowest ex-factory price of reference countries

Reference countries; France, Italy, Spain, Portugal and Greece

Import original products: Lowest ex-factory price of reference countries, countries of batch release/import

Import generic products: Lowest ex-factory price of reference countries,

countries of batch release/import and where it takes its pharmaceutical form



Agency

Euro value: 70% of previous year’s average Euro rate

70% is adaptation coefficient Price protected product : The products in which any pharmaceutical form of

their active substance(s) is (are) placed on the market for the first time worldwide before 01/08/1987



Agency

Pricing Rules Original / import

5 Reference Countries and

Countries of batch release/import - Originals w/o generic : 100% - Originals with generic : 60%

- Price protected product: 80%

Generic / import 5 Reference Countries and Countries of batch release/import and where the pharmaceutical form is taken 1) Generics with original in Turkey:

a) Price protected product : 80% of original in Turkey or 100% of import generic product (Lower one) b) If not Price protected product : 60% of RF

2) Generic w/o original in Turkey; 5 reference countries search for original product.

a) Price protected product : 80% of original or 100% of import generic product (Lower one) b) If not Price protected product ; 60% of RF

Original / Local manufactured 5 Reference Countries

- Originals w/o generic : 100% - Originals with generic : 60%

- Price protected product : 80%

Generic/ Local manufactured - Generic with original in Turkey: 60% of RF

- Price protected product with original in Turkey: 80% of RF - Generic w/o originals: 5 Reference Countries, if not; nearest generic product based on article 5/2, if not similar

pharm. form, if not cost card

Thank you for your

attention…

www.titck.gov.tr

[email protected]

http://www.titck.gov.tr/

mailto:[email protected]