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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process
Japan’s regulatory system demands the IND Application documents to be prepared in the Common Technical Document (CTD) format. Before sending an application for Investigational New Drug (IND) to the PMDA, the applicant may schedule a pre-IND meeting (consultation with PMDA), which ensures streamlined processing of IND approval. Subsequent to the application submission, PMDA evaluates the application with respect to the preclinical data, and protocols for clinical studies etc. It may probably take 30 days for initial IND and 14 days for second and consecutive INDs.
The queries received from PMDA should be answered by the applicant. After PMDA completes its review, the IND application will be transferred to Institutional Review Board (IRB) for the review. IRB takes 1-4 weeks of time for the completion of the review. Once IRB provides a favorable response, IND application will be approved after which, clinical trials can be initiated on human subjects.
New Drug Application (NDA) Filing Process
Once the applicant files NDA, PMDA reviews the application and schedules a face-to-face meeting with the applicant during which queries from PMDA are discussed. Meanwhile, GMP investigation of manufacturing site will be carried out. After the face-to-face meeting, the PMDA reviewer prepares a Review Report 1. If there are any major issues, PMDA organizes the Expert Discussion 1, which involves a discussion between the PMDA reviewer and external expert on the proposed major issue. Subsequent to the discussions with the external expert, PMDA reviewer will prepare a summary of the main issues and discuss with the applicant in a direct meeting (can be held 2 times).
Following the head-on review meeting, PMDA may organize Expert Discussion 2 with (if necessary) and prepare the Review Report 2. PMDA reviewer will submit the results of the review along with the results of GMP conformity investigation reports to Minister of Health and Labour Welfare (MHLW). MHLW upon consultation with the Pharmaceutical Affairs and Food Sanitation Council will give approval for NDA to the applicant.
As for a new drug, an assessment report is published right after the approval post which the outline of application documents (Module 1 (partially) and 2 of CTD) is published after 3 months. The standard time for approval of an NDA is approximately 12 months on an average.
In Conclusion
Japan, which was once a difficult market to enter, is now becoming an attractive investment opportunity for several global pharmaceutical companies due to the harmonization of Japan’s regulatory process with the US and EU regulatory agencies.
As the targets for generic share are expected to grow extensively in coming years, the domestic suppliers will face difficulties accomplishing it. However, on the other hand, there is a huge pool of opportunities for foreign generic manufacturers to enter the untapped Japan market. For generic drug manufacturers, to establish or expand their business in emerging markets like Japan, collaborating with a global Submissions and Publishing partner, offering flexible, end-to-end submission and publishing services would be recommended to effectively meet all their specific and unique submission requirements for quick market approvals.
