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From Strategic Planning to Successful New Drug Approval: A Triumph Journey
Company A, which is based outside of Japan, had no operations in Japan before partnering with CoreMed. With CoreMed acting as their local team for regulatory affairs, we worked collaboratively towards gaining approval. As a result of their collaborative efforts, Company A has now become a Marketing Approval Holder (MAH) in Japan and is in the process of expanding its organization.
Gap analysis
Nothing was ready for the J-NDA even though global clinical development was ongoing in Japan and other countries.CoreMed first conducted a gap analysis for the J-NDA based on their overseas CTD and gave them advice on what to do for Japan.
Pre-NDA meeting with PMDA
A pre-NDA meeting with the PMDA was one of the most important steps. On behalf of Company A, CoreMed organized the meeting with the PMDA and obtained the PMDA’s agreement on the Clinical Data Package.J-NDA (CTD) preparation
CoreMed prepared CTD modules 1 - 5. Japan has its own specific requirements and writing styles even though ICH CTD guidelines have been implemented in Japan. We provided Company A with such information and collaborated with them to rewrite Modules for Japan. We also had regular teleconferences and face-to-face meetings.
In parallel, CoreMed submitted an application for a Japanese Accepted Name (JAN) which must be granted before the J-NDA for a new molecular entity. We also advised them on Foreign Manufacturer Accreditation (FMA) which is another of the J-NDA requirements.
Besides the CTD, the J-NDA also required other documents, such as those for Compliance Inspection and GMP inspection. CoreMed helped them prepare these documents.
The product was approved on schedule. It was a great team effort. Now, the Japanese subsidiary of Company A has been well established and is expanding its organization in Japan.
