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 of utmost important to first get a confirmation on the class of registration the product will fall in before the registration process. NVS’s consultants are highly experienced to check the classification of the product based on several information required of the product. If the product is borderline between two classes of registration, NVS would guide the company for an official classification exercise by NPRA.
Based on the results of the classification of NPRA or NVS, NVS would then advice the company the next step of registration process.
Point to note, if the product is classified as a “Food Product”, it is not regulated by NPRA, but by another division of MOH called Food Safety and Quality Division. NVS would then guide the company for the next step for food product “registration”