Day 1 5 6 2 Indonesia NHidayati

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NRA FUNCTION IN CONTROLLING

VACCINES IN CLINICAL TRIAL AND

MARKETING AUTHORIZATION

INDONESIA

2013 DVI MEETING9 – 11 APRIL 2013

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The National Agency of Drug and Food Control (NA-DFC) is anon departmental government institution based on Presidential

Decree in the year 2000 which is responsible directly to the

President for its operation and build policy coordination with the

Minister of Health and Minister of Social Welfare.



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To promote and protect publichealth by among others – Ensuring safety, efficacy and quality of

medicine including vaccine, according to thenational and international standard

– Facilitating easy access to affordablemedicine regarded having public health

importance without compromising safety,efficacy and quality

MANDATE FOR THE INDONESIANREGULATORY AUTHORITY (NADFC)



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New Vaccine

which

comply with

the

requirement

of efficacy,

Safety &

Quality and

suitable withneed of

people

CLINICAL ASPECT

C O

N T R O L O F

N A D F C

Component in

new vaccine

development

REGULATION IN NEW VACCINESDEVELOPMENT (INDONESIA)

TECHNOLOGY & NON - CLINICAL IN

ANIMAL ASPECT

PRODUCTION ASPECT



Decree of Head of NADFC No.

08481/2011 on

Criteria

and

Procedure

of

Drug

Registration (Revision

of Decree 2003)

Health Law

No.36/2009

(Revision of Law

no.23/1992)

Decree of Minister

of

Health

No. 1010/2008 on

Drug

Registration

Government

Regulation

72/1998

Legal framework on Clinical Trial

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www.pom.go.id



Two mechanism for the

Control of Clinical Trial

1. Clinical

Trial

in

Indonesia

for

Registration

Purpose Investigational

New

Drug (IND)

LIKE PROCESS mechanism

2. Phase I/Phase II/Phase III Clinical

Trial

in

Indonesia

(including

multi

centre

studies) Following Requirement of Clinical

Trial

Procedures

in

Indonesia7



CT System and Procedures

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NADFCIRB/ECInvestigatorSponsor/CRO

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2

Ethic/Scientific

Review

ECApproval

CT Study

Documents

CT Study

Documents and

EC Approval

Yes

• Review• Fee

IDR 5 Mio‐CTA

IDR 10 Mio‐IND

‐CT Approval

‐Import License

GCP, GLPGMP and Quality Doc

Monitoring and Audit Inspection,monitoring onSAE Reporting

Yes

CT Study

Documents

Regular Review

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MOH-MTA

MTA Review

Approval

Post Approval

Timelines: 10 WD after documentcompletion

CTA National

Board of CT

IND

Multidiscipline

Team

CTA Submission



IND SUBMISSION

For CT Phase I/ Phase II/Phase IIIClinical Trial Application

Non Clinical Study Clinical Development

Program

Manufacturing and Controls

(CMC) CT Documents

CT Documents (Protocol,

IB, ICF, etc)

Manufacturing and Controls

(CMC)

Meeting between Sponsor

and NRA

Integrated evaluation by a

multi disciplinary team

Review on CT Documents

Clinical Trial Approval (10 WD after data completed)Drug Importation Approval

Monitoring SAE Reporting

GCP Inspection

D O C U M E N T S

R E G U L

A T O R Y

A C T I V

I T I E S

O U T

P U T

R E G U L

A T O R Y

F O L L O W - U P

A C T

I O N

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GCP InspectionP

L

N

N

I

N

G

I

N

S

P

E

C

T

I

O

N

R

E

P

O

R

T

I

N

G

Notification to the PI

& Sponsor

The inspection plan is

developed and finalised after

dates

confirmation

Summary of

observation

Main inspection takes place of

the

center/hospital

Review the

summary ofobservation

A

report

of

the

the

finding

is issued

The centerresponds and

the correctiveaction (CAPA)

plan is reviewedfor acceptability

Once CAPA isacceptable, an

inspection

closing letter isissued10



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PRODUCTS WITH REGISTRATIONNUMBER

Legally &

scientifically

consistent

ScientificallySound

Procedurally

predictable

Within time

target

Concept of Pre‐Market Evaluation

Good QualityDecision

CRITERIA AND REQUIREMENTS

GOOD

DOSSIER

PRACTICES

1. Good, clear & defined

process2. Consistent application

GOOD

DOSSIER

PRACTICES

3. Well trained people

4. Good ManagementReview Practices

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PROCEDURE TO

REGISTER DRUG IN

INDONESIA(new edition)

Decre of the Head of the National

Agency of Drug and Food ControlNo.HK.03.1.23.10.11.08481 of 2011 on

Criteria and procedure of drug

registration

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www.pom.go.id



Pharmaceutical Industries

located in Indonesia

WHO SHOULD

APPLY?

Pre-registration (timeline 40 WD)

* Determination of the registration category andevaluation path/timeline

* Consultation on completeness of registrationdossier/document

* Registration Fee

Registration

* Submit registration dossier accordingto the registration category,

How to apply

registration for

MA?

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TIMELINES for EVALUATION

• Minor variation which need approval

• Application for Export only40 WD

• Life saving drugs

• Orphan drugs

• Drugs for National Program

• Drug development and all Clinical Trials in Indonesia

• Copy Drugs with Electronic Standardized Information

• Major Variation i.e New Indication/posology for live saving drug, orphan drug, drug

for National Program , drug which developed and clinical trials in Indonesia

100

WD

•Drug which has been marketed in the countries which have

implemented harmonized evaluation system.

•Major Variation (New Indication/posology) which has been marketed inthe countries which have implemented harmonized evaluation system.

•Copy drug without Electronic Standardized Information

150 WD

•New drugs, Biological Products, Similar Biotherapeutic Products,Major Variation (New indication / posology) which are not included in

path 100 WD and 150 WD

300 WD15



DOSSIER Format-in line with ACTD

* Upon Request

Part I

Administrative Data

& Product Information

Part II

Quality

Overall Summary

& Reports

Part III

Non-clinical

Overview,Summary

& Study Reports*

Part IV

Clinical

Overview,Summary,

Country-specific

administrative data.

Not part of ACTD

ACTD

& Study Reports*Indonesia Requirement

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ICH-CTD : NCE or

new vaccine



DRUG REGISTRATION AND EVALUATION FLOWCHART

Evaluation on safety

and efficacy-Non clinical

-Clinical

Drug

registration Appl icant

Generic:

• Path 100 WD

• Path 150 WD

New Drug

and

Biological

Product:• Path 100 WD

• Path 150 WD

• Path 300 WD

Appeal

Comply? Labelling

evaluation

MA

Yes

No

Evaluation on Quality

National Committee on

Drug Evaluation

SMF data forimport drug *)

Pre inspection

documentevaluation

Comply? Inspection

No

Yes

Yes

No

*) Pharmaceutical Industry should be inspected

Addi tional

DataRejected

- Abreviated Safety

and efficacy data

- BioequivalenceData

Completeness

Assessment

Pre

Registration

ResultPre

Registration

Consultation

Legends:

Pre Registration

Registration

SMF Evaluation

Rejection/Appeal

Addi tional Data

Comply?

In Situ

40 WD

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Consist of experts in the field of clinical

pharmacology, pharmacy, biology and relevant

clinicians

Recruited from Universities and other relevant

institutions

Sign statement of independency (not to have a

conflict of interest)

Conducting meeting regularly to discuss the result

of evaluation on the safety, efficacy and quality of

drugs

NATIONAL COMMITTEE

ON DRUG EVALUATION



Quality aspect:•Inspection on GMP:

to ensure that the drug products are consistently

manufactured according to standard of Q requirement.•Inspection on GDP :

to ensure that the drug products are distributed in

expedited manner to provide its accessibility for thepatients.

• Sampling of marketed product and Laboratory testing

Monitoring of labelling,advertising and other promotional activities

Safety aspects :

Monitoring of Adverse Drug Reactions /Pharmacovigilance

POSTMARKET CONTROL

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Our website: www.pom.go.id

Regulatory consultation: send queries toDirectorDrug and Biological Products [email protected]

http://www.pom.go.id/

mailto:[email protected]

mailto:[email protected]

http://www.pom.go.id/