Registration of pharmaceutical products in Malaysia is not as straight forward process as compared to other ASEAN countries. The Ministry of Health Malaysia (MOH) had appointed a government body, National Pharmaceutical Regulatory Agency (NPRA) for main task of registration of products. NPRA has many functions tasked by MOH such as...
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In Malaysia, there are several classes of pharmaceutical registration regulated by NPRA. These would include New Chemical Entity, Biological, Generic, Over The Counter (OTC), Health Supplement, Herbal and Cosmetic. Each class of pharmaceutical registration would require different set of documentations and timeline for registration would differ. Thus, it would be...
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For registration of any pharmaceutical products with NPRA, the entire process is done online with soft copies of document uploaded. Whereby the entire process would be done through the website www.npra.moh.gov.my/q3plus/. This QUEST3PLUS website is managed by NPRA and represents the third generation of online registration system. It has many...
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