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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
Mar 14, 2024 · Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of GLP is to promote the development of quality data.
Paragraph 7 (1) (a) of the Control of Drugs and Cosmetics Regulations 1984 requires all products to be registered with the DCA prior to being manufactured, sold, supplied, imported, possessed or administered, unless the product is exempted under the specific provisions of the Regulations. A ‘product’ as defined in the Regulations means.
Document Name. Updated. Drug Registration Guidance Document (DRGD), 3rd Edition, Seventh Revision January 2024 ( Main body) Jan 2024. Appendix 1 : Food Drug Interphase (FDI) Products. Jan 2024. Appendix 2 : Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products. Jan 2024.
Aug 7, 2023 · This information is an update to the NPRA Safety Alerts published on 31 December 2021.. Overview. Clindamycin is a lincosamide antibiotic indicated for the treatment of various infections caused by susceptible anaerobic bacteria, susceptible strains of gram-positive aerobic bacteria such as streptococci, staphylococci and pneumococci, and susceptible strains of Chlamydia trachomatis. 1 In ...
Sep 7, 2018 · Template for Declaration of Worldwide Registration Status (WWRS) E15. -. Download. 3/2023. Borang Permohonan Sijil Indikasi / Sijil Deklarasi. Download. Download. 4/2023. Screening Checklist for Generics Application.
