CMC Strategy Forum Japan November Piyanan Boonprasirt Bureau of Drug Control Thailand Food and Drug Administration

Transcription

1 CMC Strategy Forum Japan November 2015 Piyanan Boonprasirt Bureau of Drug Control Thailand Food and Drug Administration 1

2 1. Background 2. Organization Chart 3. Biological Products 4. Regulation of Biopharmaceuticals - Legal Bases & Guidelines - Drug Registration Process 5. The Recent Regulations Related to Biopharmaceuticals 2

3 Article 79, Drug Act B.E.2510 No drug can be manufactured in or imported into Kingdom of Thailand unless it obtains a marketing authorization from Thai Food and Drug Administration (ThaiFDA) 3

4 Food and Drug Administration (FDA) Department of Medical Sciences (DMSC) Provincial Health Offices 4

5 Bureau of Drug Control Administrative Subdivision National Drug Policy System Development Division Pre-marketing Division Standard and Regulation Division Postmarketing Division 5

6 Pre-marketing Division Pharmaceutical (Chemical) Product Sub-division Biological Products Subdivision Veterinary Drug Sub-division Herbal and Traditional Drug Sub-division IND Subdivision Advertising Control Subdivision 6

7 Definition Derived from living organisms, human blood and plasma or manufactured by biotechnology Require biological assay Prepared with biological processes Consisting of substances of higher molecular weight Purity, potency and composition cannot readily and reliably be determined by chemical or physicochemical analysis 7

8 Example Monoclonal antibodies Growth factors and cytokines Blood or Plasma derived medicines Vaccines Products of genetic engineering or other newer biotechnological techniques etc. 8

9 Quality Safety Efficacy Legal Bases & Guidelines 9

10 Legal Bases & Guidelines 1. Drug Act B.E.2510 (A.D.1967) amended by Drug Act (No.2) B.E.2518 (1975) Drug Act (No.3) B.E.2522 (1979) Drug Act (No.4) B.E.2527 (1984) Drug Act (No.5) B.E.2530 (1987) 10

11 Legal Bases & Guidelines 2. World Health Organization (WHO) 3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human (ICH) 11

12 Legal Bases & Guidelines 4. The ASEAN Common Technical Dossier (ACTD) for The Registration of Pharmaceuticals for Human Use 5. The ASEAN Common Technical Requirement (ACTR) for The Registration of Pharmaceuticals for Human Use 6. etc. 12

13 Legal Bases & Guidelines; ACTD&ACTR Part 1 Administrative Data and Product Information Part 2 Quality Part 3 Non-Clinical Part 4 Clinical 13

14 Legal Bases & Guidelines; ACTD&ACTR Part 1 Administrative Data and Product Information Application Form; MA 1 Form Certification of Free Sale (CFS)/ Certification of Pharmaceutical Product(CPP/COPP) GMP certification 14

15 Legal Bases & Guidelines; ACTD&ACTR Part 1 Administrative Data and Product Information Labeling Product information; Summary of Product Characteristic(SPC) Package insert (PI) Patient Information Leaflet (PIL) etc. 15

16 Legal Bases & Guidelines; ACTD&ACTR Part 2 Quality Drug Substance (S) Drug Product (P) 16

17 Legal Bases & Guidelines; ACTD&ACTR Manufacturing Process; Vials => Storage&Shipping Control of Material; Biological origin, Cell substrate, Cell banking system Process Validation; Aseptic and sterilization processes Control of Drug Substance; Specify source Test of Finished Product; Purity, Potency, Stability, Immunogenicity etc. 17

18 Legal Bases & Guidelines; ACTD&ACTR Part 3 Non-clinical Study reports may not be required if the products are already approved in reference countries Pharmacology Pharmacokinetics Toxicology 18

19 Legal Bases & Guidelines; ACTD&ACTR Part 4 Clinical Study reports may not be required if the products are already approved in reference countries Clinical Pharmacology Studies Clinical Efficacy Clinical Safety 19

20 Drug registration process 2 main steps The permission to import/manufacture drug sample The approval of certificate 20

21 Timeline Categories Timeline (working days) New Biological Products 320 Conventional Biological Products 160 New Vaccines 350 Conventional Vaccines

22 1. New submission process 2. Electronic Submission (e-submission) 3. Biosimilar guideline 22

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25 Electronic Common Technical Document (ectd) First country in ASEAN Planning for ectd v4.0/ Regulated Product Submissions (RPS) 25

26 ectd; 5 Modules Module 1 TH ectd; Admisitrative Information and Prescribing Information Module 2 ectd; Summaries Module 3 ectd; Quality Module 4 ectd; Nonclinical Study Reports Module 5 ectd; Clinical Study Reports 26

27 Module 1 TH ectd Structure 1.0 Cover Letter 1.2 Application Form 1.3 Product Information 1.4 Information about the Experts 1.5 Specific Requirements for Different Types of Applications 1.6 Environmental Risk Assessment 1.7 Information relating to Orphan Market Exclusivity 1.8 Information relating to Pharmacovigilance 1.9 Information relating to Clinical Trials 1.10 Information relating to Pediatrics 1.R Responses to Questions 1.A Additional Data 27

28 Transition An option after ectd pilot phase 2016; New Biological, Biological, New Drug 2017; All submission 28

29 Advantages Reduce paper base Immediate access to relevant information Increase the efficiency of the review process Overall timelines is meet 29

30 Challenges Training for the reviewers Software Cost 30

31 General Guideline Part 1 Part 2 Part 3 Part 4 Part 5 Administrative data and product information Quality Document Non-clinical Document Clinical Document Pharmacovigilance and risk management plan Document 31

32 Specific Guideline Somatropin Interferon Alpha Monoclonal Antibody Granulocyte colony-stimulating factor (GCSF) 32

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