Further improvement of the national testing process and international harmonization of regulatory requirements

The national examination process in Japan is gradually improving as a result of many years of discussions between industry, academia, and government. We reviewed the establishment of each article of each drug in the Biologics Standards, examined the simplification of the description while ensuring consistency of the test method between the formulations, and in 2023, it was deleted from each article of the drug in the abnormal toxicity denial test, and studies are being conducted to ensure the consistency of the description method of the test method in the pharmaceutical clause, and each company is responding to changes. In the future, we are continuing to consider test methods from animal tests to in vitro tests while holding discussions between industry, academia and government. In addition, as a state of national certification, a policy was also indicated that only SLP can be used for examination of formulations that meet certain criteria, and several items that were accepted for examination only by SLP were selected according to the standards. On the other hand, many vaccines are required to be tested by national certification, and it is still difficult to say that the double burden has been resolved. Imported products are exported after undergoing overseas national certification, but even after importation, the Japan national certification system often requires them to conduct tests again in Japan in accordance with Japan-specific biologics standards. The submission of test samples for national examinations involves the National Institute of Infectious Diseases(NIID), the MHLW, and prefectural officials, and the coordination work is a burden on companies. In particular, even when testing only in writing using SLP, one vaccine sample must be taken in the presence of prefectural officials. This is said to be a response stipulated in the Pharmaceuticals and Medical Devices Law, but it is an inefficient system and needs to be reviewed. For example, if overseas factories can randomly take vaccines in advance and send them directly to the NIID, the lead time for supplying imported vaccines will be somewhat shortened. Discussions continue on the efficiency of direct provision of sample samples and the ideal state test for SLP only. On the other hand, the integration of the NIID and the National Center for Global Health and Medicine has been decided, and there is a need for institutions that conduct national examinations and new operational changes, and it is necessary to discuss these matters as well. In addition, if pre-approval inspections are really a requirement for approval, or if only technology is to be transferred to prepare for national examinations, it is necessary to abolish pre-approval inspections and discuss how to build a new framework. EFPIA Japan will continue to request that products that have passed national examinations in Europe and the United States at least be screened only by SLP, and that the national examinations be streamlined by sample submission. We are also proposing a review of the standards for biological raw materials, which are being discussed by the AMED research group and others. It is also necessary to consider the fact that vaccines that have been widely used for a long time in Europe and other countries are extremely difficult to introduce in Japan because the information on biological raw materials contained in Star Cell Bank/Master seed does not meet the standards for biological raw materials.


  • Strengthen cooperation with the Pharmaceuticals and Medical Devices Agency, the MHLW, and the prefectural and NIID, which are the testing organizations, or improve the efficiency of pharmaceutical review and assay functions
  • Review of sample sampling methods so that overseas manufacturing facilities can also take test samples
  • Reduction of the number of certified lots by utilizing SLP and expansion of SLP-only items, including newly approved products