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  Regulatory Guidelines

Guidelines on Regulatory:
No Document Name Type Size
1. Malaysia Variation Guideline for Pharmaceutical Products 2013 (First Edition) Click to Download 0.55 MB
2. Drug Registration Guidance Document (DRGD) (updated 30 April 2013) Click to Download 4.82 MB
3. Jadual Pengkelasan Medical Device - Drug - Cosmetic Interface.pdf Click to Download 0.14 MB
4. Malaysian Transition Strategy for the Phase Out of Chlorofluorocarbon in Metered Dose Inhalers Click to Download 19.83 MB
5. Guideline for Application for Registration of Biologicals / Biotechnology Products Click to Download 0.03 MB
6. Garispanduan Pelaksanaan Risalah Maklumat Ubat untuk Pengguna (RiMUP) April 2013 Click to Download 0.37 MB
7. Regulatory Control of Active Pharmaceutical Ingredients Click to Download 0.20 MB
8. Good Distribution Practice Click to Download 0.50 MB
9. Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements Click to Download 0.26 MB
10. Guidance Document and Guidelines for Registration of Biosimilars in Malaysia Click to Download 0.16 MB
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>>> Other Guidelines are listed here.

 

 

 




 
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