Other Guidelines for Generic Medicine

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Guidelines - Generic Medicine

: Posted By Jauze; 05 October 2018; Hits: 5864

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2019
- Drug Registration Guidance Document : Second Edition – September 2016, Revised January 2020 2019-11-01
- 4.4 : Post-Marketing Activities 2019-03-13
2018
- Guidelines for Clinical Trial 2018-08-30
- Product Validation 3.1 - 3.8 : Active Ingredients 2018-08-29
- Product Validation 4.1 - 4.5 : Excipients 2018-08-29
- Product Validation PV5 - PV18 : Other Information 2018-08-29
- Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) 2018-08-01
- Variation Application For Pharmaceutical Products 2018-07-25
2016
- Malaysian Pharmacovigilance Guidelines 2nd Edition 2016-09-07

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National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.

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

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