We strive hard to work closely and forming a partnership with clients to achieve the objective – product registration !
We evaluate the registration documents in detailed up front to reduce number of queries from Ministry of Health officials
Being fast to respond accurately to any queries in this everchanging regulatory landscape is the crucial aspect of the entire process
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...Read more
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...Read more
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...Read more