Search results
This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products.
Applicants are advised to refer to the NPRA website for the latest updates of the DRGD and other related guidelines. Separate guidelines are available for Cosmetics and Veterinary products at the NPRA
The main body of the DRGD (62 pages) and its appendices can be downloaded separately from the NPRA website for easy viewing. List of DRGD updates will be published with the DRGD on the NPRA website. 31 January 2021
This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post- registration activities of medicinal products.
The scope of this DRGD includes information relating to administrative requirements and procedures for: a) Submission of an application for the registration of medicinal products, which
There are eight (8) amendments for the April 2023 DRGD Updates as follows: Main Body of DRGD Third Edition, Fourth Revision January 2023.
National Pharmaceutical Regulatory Agency (NPRA) - Home
Dec 28, 2023 · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400
National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400
6 days ago · While NPRA is still reviewing this safety issue, be aware of the potential associations between the risks of rare but high-morbidity PG with the use of anti-CD20 antibodies. Educate patients to watch for symptoms of PG such as painful, rapidly expanding, non-healing skin ulcerations, and specifically advise female patients to monitor any ...