Registration Process Scenario in Malaysia
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 belowevaluate any product registration of pharmaceutical nature in Malaysia
a) evaluate any product registration of pharmaceutical nature in Malaysia
b) carry out test on the product before registration
c) evaluate all the technical documentation for registration
d) take random samples from the market for lab testing
e) manage all pharmaceutical product complaints and the Adverse Drug Reaction Monitoring
Throughout the NPRA’s 39 years of existence in Malaysia, it has guided Malaysia to become a member of the PICS (Pharmaceutical Inspection Co-Operation Scheme), WHO Collaborating Centre and a leading member in the ASEAN region for pharmaceutical industry development. Following its growth, comes an increase in new stringent requirements by NPRA for registration of pharmaceuticals in Malaysia. This warrants a newer generation of regulatory consultants to keep up with the ever-changing landscape of pharmaceutical registration in Malaysia. NVS Regulatory Services has several consultants who are experienced in their own respective regulatory field be it from Generic to Herbal to Health Supplements to Biologicals and even Medical Device! The consultants are trained to be fast and precise for any regulatory advices any client would require.