NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL

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1 NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL

2 2

3 The National Agency of Drug and Food Control (NA-DFC) is a non 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. 3

4 MANDATE FOR THE INDONESIAN REGULATORY AUTHORITY (NADFC) To promote and protect public health by among others Ensuring safety, efficacy and quality of medicine including vaccine, according to the national and international standard Facilitating easy access to affordable medicine regarded having public health importance without compromising safety, efficacy and quality 4

5 REGULATION IN NEW VACCINES DEVELOPMENT (INDONESIA) CONTROL OF NADFC Component in new vaccine development TECHNOLOGY & NON - CLINICAL IN ANIMAL ASPECT CLINICAL ASPECT PRODUCTION ASPECT New Vaccine which comply with the requirement of efficacy, Safety & Quality and suitable with need of people 5

6 Legal framework on Clinical Trial Health Law No.36/2009 (Revision of Law no.23/1992) Government Regulation 72/1998 Decree of Minister of Health No. 1010/2008 on Drug Decree of Head of Registration NADFC No /2011 on Criteria and Procedure of Drug Registration (Revision of Decree 2003) 6

7 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 Indonesia 7

8 CT System and Procedures Sponsor/CRO Investigator IRB/EC NADFC MOH-MTA CTA Submission CT Study Documents 1 CT Study Documents EC Approval Yes Ethic/Scientific Review CTA National Board of CT IND Multidiscipline Team MTA Review CT Study Documents and EC Approval Review Fee IDR 5 Mio CTA IDR 10 Mio IND Approval GCP, GLP GMP and Quality Doc Yes 2 CT Approval Import License Post Approval Monitoring and Audit Regular Review Timelines: 10 WD after document completion Inspection, 4 monitoring on 8 SAE Reporting

9 DOCUMENTS REGULATORY ACTIVITIES IND SUBMISSION For CT Phase I/ Phase II/Phase III Non Clinical Study Clinical Development Program Manufacturing and Controls (CMC) CT Documents Meeting between Sponsor and NRA Integrated evaluation by a multi disciplinary team Clinical Trial Application CT Documents (Protocol, IB, ICF, etc) Manufacturing and Controls (CMC) Review on CT Documents OUTPUT Clinical Trial Approval (10 WD after data completed) Drug Importation Approval REGULATORY FOLLOW-UP ACTION Monitoring SAE Reporting GCP Inspection 9

10 GCP Inspection P L A N N I N G Notification to the PI & Sponsor The inspection plan is developed and finalised after dates confirmation I N S P E C T I O N R E P O R T I N G Summary of observation Review the summary of observation A report of the the finding is issued Main inspection takes place of the center/hospital The center responds and the corrective action (CAPA) plan is reviewed for acceptability Once CAPA is acceptable, an inspection closing letter is issued 10

11 11

12 Concept of Pre Market Evaluation CRITERIA AND REQUIREMENTS Scientifically Sound Within time target GOOD DOSSIER PRACTICES Procedurally predictable Legally & scientifically consistent GOOD DOSSIER PRACTICES 1. Good, clear & defined process 2. Consistent application Good Quality Decision 3. Well trained people 4. Good Management Review Practices PRODUCTS WITH REGISTRATION NUMBER 12

13 PROCEDURE TO REGISTER DRUG IN INDONESIA (new edition) Decre of the Head of the National Agency of Drug and Food Control No.HK of 2011 on Criteria and procedure of drug registration 13

14 WHO SHOULD APPLY? Pharmaceutical Industries located in Indonesia Pre-registration (timeline 40 WD) * Determination of the registration category and evaluation path/timeline * Consultation on completeness of registration dossier/document * Registration Fee How to apply registration for MA? Registration * Submit registration dossier according to the registration category, 14

15 TIMELINES for EVALUATION 40 WD Minor variation which need approval Application for Export only 100 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 150 WD Drug which has been marketed in the countries which have implemented harmonized evaluation system. Major Variation (New Indication/posology) which has been marketed in the countries which have implemented harmonized evaluation system. Copy drug without Electronic Standardized Information New drugs, Biological Products, Similar Biotherapeutic Products, Major Variation (New indication / posology) which are not included in path 100 WD and 150 WD 300 WD 15

16 DOSSIER Format-in line with ACTD Country-specific administrative data. Not part of ACTD Part I Administrative Data & Product Information ICH-CTD : NCE or new vaccine ACTD Part II Quality Part III Non-clinical Part IV Clinical Overall Summary Overview, Summary & Reports & Study Reports* Indonesia Requirement Overview, Summary, & Study Reports* * Upon Request 16

17 DRUG REGISTRATION AND EVALUATION FLOWCHART 40 WD Legends: Consultation Pre Registration Applicant Pre Registration Result Drug registration New Drug and Biological Product: Path 100 WD Path 150 WD Path 300 WD National Committee on Drug Evaluation Evaluation on safety and efficacy -Non clinical -Clinical In Situ Pre Registration Registration SMF Evaluation Rejection/Appeal Additional Data Comply? Yes Labelling evaluation Data Completeness Assessment - Abreviated Safety and efficacy data - Bioequivalence No MA Generic: Path 100 WD Path 150 WD Evaluation on Quality Rejected Additional Data Appeal Yes SMF data for import drug *) Pre inspection document evaluation Comply? No Yes Inspection Comply? No 17 *) Pharmaceutical Industry should be inspected

18 NATIONAL COMMITTEE ON DRUG EVALUATION 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 18

19 POSTMARKET CONTROL Safety aspects : Monitoring of Adverse Drug Reactions /Pharmacovigilance 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 the patients. Sampling of marketed product and Laboratory testing Monitoring of labelling,advertising and other promotional activities 19

20 Our website: Regulatory consultation: send queries to Director Drug and Biological Products Evaluation 20

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