Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently held their second International Symposium on Biologics in January 2008. Summaries of this Symposium were recently made public. Senior Advisor Dr. Takao Hayakawa of the PMDA presented the current regulatory environment for biologics in Japan and also proposed new regulations for biologics.
Japan’s Ministry of Health, Labor, and Welfare (MHLW) currently regulates cell/tissue-based products based on two notifications. One is MHLW Notification No.266 (issued March 28, 2001) titled, “General Principles for the Handling and Use of Cells/Tissue-Based Products.†The other is MHLW Notification No.1314 (issued November 26, 2000) titled, “Guideline on Ensuring Quality and Safety of Products Derived from Processed Human Cells/Tissue.â€
Dr. Hayakawa proposed revising these current guidelines. Specifically, he suggested developing specific guidelines for autologous cells/tissue-based products (same donor and recipient) compared to allogeneic ones and establishing a “kakunin shinsei†document. This “kakunin shinsei†document would provide data to confirm the quality and safety of a product before the product underwent investigational clinical trials.
As of now, there are no official guidelines for subsequent-entry protein products in Japan. “Subsequent-entry protein products†means any protein product that is produced using a new manufacturing process by a subsequent-entry manufacturer. This manufacturer may claim that their product is comparable or similar to an already existing protein product developed by an innovator. However, the new product has not been established as comparable or similar.
To demonstrate that subsequent-entry protein products are indeed comparable or similar, Dr. Hayakawa emphasized providing extensive CMC (Chemical Manufacturing and Controls) data and well-known established data. Subsequent-entry protein products cannot be defined as comparable or similar a priori.
Dr. Hayakawa also suggested extensive identification and characterization studies demonstrating the safety, purity, potency, identity and stability of the product. To ensure safety, Dr. Hayakawa also proposed that post-approval clinical studies may be necessary as data from pre-approval non-clinical and clinical studies may be insufficient.