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1. www.npra.gov.my › index › enNew Products Approved - National Pharmaceutical Regulatory Agency...

   www.npra.gov.my › index › en

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   Jun 13, 2024 · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400

2. www.npra.gov.my › index › enGuidelines - National Pharmaceutical Regulatory Agency (NPRA)

   www.npra.gov.my › index › en

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   Guidance Document and Guidelines for Registration of Biosimilars in Malaysia. 19 February 2024. Hits: 11176. Guideline For Facilitated Registration Pathway. 18 February 2024. Hits: 8245. Guidelines on Conditional Registration for New Chemical Entities and Biologics in Malaysia - 2nd Edition - December 2020. 25 May 2022. Hits: 5188.

3. www.npra.gov.my › index › myCarian Produk Berdaftar / Bernotifikasi

   www.npra.gov.my › index › my

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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

4. www.npra.gov.my › index › enBioequivalence (BE) Main Page - National Pharmaceutical...

   www.npra.gov.my › index › en

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   Guidelines on Bioequivalence. Malaysia has fully adopted ASEAN guideline since March 2015 and it is the most current guide for the conduct of bioequivalence studies. This guideline is adopted from the Guideline on the Investigation of Bioequivalence” (European Medicines Agency, London, 20 January 2010, CPMP/EWP/QWP/1401/98 Rev 1) with some ...

5. www.npra.gov.my › index › enProduct Registration Process - National Pharmaceutical Regulatory...

   www.npra.gov.my › index › en

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   6 days ago · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

6. www.npra.gov.my › index › enIndustry | Product Registration & Licensing System QUEST3+

   www.npra.gov.my › index › en

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   6 days ago · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400

7. www.npra.gov.my › index › enNPRA

   www.npra.gov.my › index › en

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   6 days ago · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400