New pharmaceutical and medical device requirements went into effect November 25 in Japan that affect the way products are regulated. The changes come as a result of newly enacted amendments to the Pharmaceutical Affairs Act of 1960, which will be renamed the Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical Products and Medical Devices.
The changes serve primarily to ensure the safety of pharmaceutical products and medical devices, and they set up new regulations for cell-remedying medical products, tissue-engineered medical products, and gene-remedying medical products.
Among the new requirements: Medical devices will be regulated separately from pharmaceuticals; software used to diagnose and treat medical conditions will now be regulated as medical devices; medical device companies must register every factory; and quality inspections will be required for factories for every category of medical devices. The new law eliminates manufacturer licensing, instead implementing a listing process much like that used in the United States.
Taken together, these changes represent a big liberalization of Japan’s regulations, “allowing much greater access to third party assessment pathways, removing a raft of unique local requirements” and streamlining processes, according to Brandwood Biomedical, an Australian regulatory and quality services company.
More information about the new regulations is available from Japan’s Pharmaceuticals and Medical Devices Agency.