Other Guidelines for Generic Medicine

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Guidance for Generic Medicine

: Posted By Ng Pei Ling; 10 August 2022; 07 March 2023; Hits: 29413

User Rating: 3 / 5

1. Drug Registration Guidance Document (DRGD), Third Edition, Fourth Revision Jan 2023

2. ASEAN Common Technical Dossier (ACTD)

Organization of the Dossier

Glossary used for the ACTD and ACTR

Part II: Quality

Part III: Nonclinical Document

Part IV: Clinical Document

ACTD Clinical Check List for Product Classification

3. ASEAN Common Technical Requirements (ACTR)

ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration (includes all annexes)

ASEAN Guideline on Process Validation Q&A

ASEAN Guideline on Stability Study of Drug Product (R1)

ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies

4. Malaysian Guideline

Malaysian Variation Guideline for Pharmaceutical Products, 2nd Edition (July 2022)

5. Guide on Uploading the Documents in QUEST 3+ System

Section E12 & E13

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( 7 Ratings )

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

Phone: +603-7883 5400

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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Last Modified: Tuesday 03 October 2023, 11:04:24.