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