Drug Registration Guidance Document

Drug Registration Guidance Document (January, 2009) - New! 195 pages

Click here to download

Refer to http://www.bpfk.gov.my/ > regulatory information

CONTENT

PREAMBLE

List of amendments / changes:

SECTION 1: GENERAL OVERVIEW OF THE DRUG REGISTRATION

SYSTEM IN MALAYSIA (INCLUDING ADMINISTRATIVE PROCEDURES)

1. INTRODUCTION

2. DRUG REGISTRATION

3. PROCEDURE FOR PROCESSING NEW APPLICATIONS

3.1 Application Type

3.2 Data Requirements

4. APPLICATION FORMALITIES

4.1 Responsibility of Marketing Authorization Holder (i.e. the applicant

for product registration)

4.2 Application Fee

4.3 Letter of Authorization and Certification Which Must Accompany

Applications

4.4 Multiple Applications

5. PROCESSING OF APPLICATIONS

5.1 Initiation of Review

5.2 Stop Clock

6. REGULATORY OUTCOME

6.1 Decisions of the DCA

6.2 Product Registration Number

6.3 Certificate of Registration [Reg. 8(8]

6.4 Rejection, Cancellation, Suspension of Registration [Regs. 11 & 17(1)]

6.5 Appeal against DCA Decisions [Reg. 18]

6.6 Decision of the Minister or the Director of Pharmaceutical Services[Reg. 18]

7. MAINTENANCE OF REGISTRATION

7.1 Conditions for Registration [Reg. 8(1)]

7.2 Validity Period of Registration [Reg. 8(5)]

8. CHANGE IN PARTICULARS OF REGISTERED PRODUCTS

9. REPORTING PROBLEMS WITH REGISTERED PRODUCTS

9.1 Adverse Drug Reactions

9.2 Market Surveillance of registered products

9.3 Product Complaints

9.4 Product Recalls

10. TERMINATION OF PRODUCT REGISTRATION BY MARKETING

AUTHORIZATION HOLDER

11. CHANGE IN MARKETING AUTHORIZATION HOLDER OF A REGISTERED PRODUCT

12. CHANGE IN MANUFACTURING SITE

13. OTHER INFORMATION

13.1 Criteria for registration

13.2 Variants for a Given Product

13.3 Patented Products

13.4 Products for export only

13.5 Combination (Combo) Packs

13.6 Use of HALAL logo

13.7 Bioequivalence

13.8 New / additional indication

14. TYPES OF APPLICATIONS

15. APPENDICES

SECTION 2: GUIDE ON HOW TO FILL THE ON-LINE APPLICATION

FORM FOR A NEW PRODUCT REGISTRATION

STEP 1: PRODUCT VALIDATION FORM

[1] PRODUCT NAME

[2] DOSAGE FORM

[3] ACTIVE SUBSTANCE

[4] EXCIPIENT

[5] ANY PORCINE MATERIALS

[6] MANUFACTURER

[7] PRODUCT CLASSIFICATION

STEP 2: NEW REGISTRATION APPLICATION FORM

PART I . ADMINISTRATIVE DATA AND PRODUCT INFORMATION

SECTION A: PRODUCT PARTICULARS

 Product Description :

 Pharmacodynamics & Pharmacokinetics (for full evaluation only)

 Indication/Usage

 Dose/Use Instruction

 Recommended Dose & Route of administration (for full evaluation

Only)

 Contraindication

 Warnings and Precautions

 Drug Interactions

 Side Effects /Adverse Reactions

 Pregnancy and Lactation (for full evaluation only)

 Signs and Symptoms of Overdose and Treatment

 Storage Conditions

 Shelf Life

 Therapeutic Code (If any)

SECTION B: PRODUCT FORMULA

 Batch Manufacturing Formula

 Manufacturing process (for abridged evaluation procedure only)

 Attachment of In Process Quality Control (for abridged evaluation

procedure only)

 Attachment of Finished Product Quality Specification (for abridged

evaluation procedure only)

 Attachment of Stability Data (for abridged evaluation procedure only)

177

SECTION C: PARTICULARS OF PACKING

SECTION D: LABEL (MOCKUP) FOR IMMEDIATE CONTAINER, OUTER

CARTON AND PROPOSED PACKAGE INSERT

ANNEX A

Guidelines for the Submission of Protocol of Analysis

I. General Requirements

II. Specific Requirements

Guideline for Submission of Samples to the Drug Analysis Division for

Laboratory Testing

I. Introduction

II. Requirements

III. Appeal for retesting

Guideline for Submission of Analytical Method Validation Documents

I. Introduction

II. Requirements

Garis Panduan Mengemukakan Dokumen Validasi Analitikal (Pengujian

Mikrobiologikal)

I. Ujian Kontaminasi Mikrobial

II. Esei Antibiotik Cara Mikrobiologikal

III. Ujian Steriliti