Case Study 156: Registration of DMF in Japan for COVID-19 Vaccine

Company Situation

Client has approved nanoparticle-based vaccines against Covid-19 in global markets such as USA and Europe. Considering vaccines need in Japan and its plans for commercialization, the client needed a regulatory partner based in Japan who could help register and maintain their Drug Master File (DMF).

GRP Solution

GRP Japan is helping multiple global API and drugs manufacturers register and maintain their DMF in Japan. GSK Japan is In Country Caretaker for these companies representing them to PMDA for all their compliance needs. Using this experience, GRP helped the Client throughout the DMF registration process and successfully obtain the approval. GRP continues to maintain the DMF for client and address and PMDA queries post approval considering the critical nature of the indication.

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