Other Guidelines for Generic Medicine

Directory | Consumers

Increase size

Reset to Default

Decrease size

Guidance for Generic Medicine

: Posted By Ng Pei Ling; 10 Ogos 2022; 07 Mac 2023; Jumlah paparan: 25823

Kadar pengguna: 3 / 5

bintang aktif

bintang aktif

bintang aktif

Bintang tidak aktif

Bintang tidak aktif

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

Rating:

( 7 Ratings )

National Pharmaceutical Regulatory Agency (NPRA)

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

Email: npra@npra.gov.my
Phone: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075

More Links

DISCLAIMER

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.

Mobile Web :

Site Last Modified

Last Modified: Jumaat 26 Mei 2023, 09:15:39.