Generic Product Registration


Generic Product Registration: Generic Product is defined by NPRA as a product that is essentially similar to a currently registered product in Malaysia. The first company to register a product or a molecule in Malaysia would be given the status of “innovator”. As this company would need to provide documents and supporting clinical trials to NPRA to establish the need of registering the product in Malaysia. Any other registration of the similar product or molecule would be done via the Generic registration route. Generic registration would not have such extensive document requirements for registration as an “innovator” would. However, NPRA still requires sufficient number of documents to establish the product’s quality and efficacy as compared to the “innovator”.

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