CMC Strategy Forum Japan 2015 9-10 November 2015 - c.ymcdn.com · CMC Strategy Forum Japan 2015 9-10 November 2015 ... Quality Module 4 eCTD; ... management plan Document 31

CMC Strategy Forum Japan 20159-10 November 2015

Piyanan Boonprasirt

Bureau of Drug Control Thailand Food and Drug Administration

1

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

CMC Forum Japan 20152


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 DrugAdministration (ThaiFDA)”

3


Food and Drug Administration (FDA)

Department of Medical Sciences (DMSC)

Provincial Health Offices


Bureau of Drug Control

National Drug Policy

System Development

Division

Pre-marketing Division

Standard and Regulation

Division

Post-marketing Division

Administrative Sub-division


Pre-marketing Division

Pharmaceutical (Chemical)

Product Sub-division

Biological Products

Sub-division

Veterinary Drug

Sub-division

Herbal and Traditional Drug

Sub-division

IND Sub-

division

Advertising Control

Sub-division


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

Monoclonal antibodies

Growth factors and cytokines

Blood or Plasma derived medicines

Vaccines

Products of genetic engineering or

other newer biotechnological techniques

etc.


Example


Legal Bases & Guidelines

Quality Safety Efficacy

9

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

2. World Health Organization (WHO)

3. International Conference on

Harmonization of Technical

Requirements for Registration of

Pharmaceutical for Human (ICH)



11


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



Part 1 Administrative Data and

Product Information

Part 2 Quality

Part 3 Non-Clinical

Part 4 Clinical13

Legal Bases & Guidelines; ACTD&ACTR


Product Information


Application Form; MA 1 Form

Certification of Free Sale (CFS)/

Certification of Pharmaceutical

Product(CPP/COPP)

GMP certification

14



Labeling

Product information;

• Summary of Product Characteristic(SPC)

• Package insert (PI)

• Patient Information Leaflet (PIL)

etc.

15


Product Information



Drug Substance (S) Drug Product (P)

16


Part 2 Quality


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



Study reports may not be required if the

products are already approved in

reference countries

Pharmacology

Pharmacokinetics

Toxicology

18


Part 3 Non-clinical



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


Drug registration process

2 main steps The permission to

import/manufacture drug sample

The approval of certificate

20

Timeline


Categories Timeline(working days)

New Biological Products 320

Conventional Biological Products

160

New Vaccines 350

Conventional Vaccines 350

21

1. New submission process

2. Electronic Submission

(e-submission)

3. Biosimilar guideline





Electronic Common Technical

Document (eCTD)

First country in ASEAN

Planning for eCTD v4.0/

Regulated Product Submissions

(RPS)

25


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


Module 1 TH eCTD Structure

27

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


An option after eCTD pilot phase

2016; New Biological, Biological, New Drug

2017; All submission

28

Transition


Advantages

Reduce paper base

Immediate access to relevant

information

Increase the efficiency of the

review process

Overall timelines is meet

29


Challenges

Training for the reviewers

Software

Cost

30


Part 1 Administrative data and

product information

Part 2 Quality Document

Part 3 Non-clinical Document

Part 4 Clinical Document

Part 5 Pharmacovigilance and risk

management plan Document

31

General Guideline


Specific Guideline

Somatropin

Interferon Alpha

Monoclonal Antibody

Granulocyte colony-stimulating

factor (GCSF)


CMC Strategy Forum Japan 2015 9-10 November 2015 - c.ymcdn.com · CMC Strategy Forum Japan 2015 9-10 November 2015 ... Quality Module 4 eCTD; ... management plan Document 31

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