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

As a result of discussions among industry, MHLW/PMDA and the NIID (National Institute of Infectious Diseases) over many years, the national test process in Japan is gradually improving. The establishment of the monographs in the MRBP (Minimum Requirements for Biological Products) was reviewed, and simplification of the descriptions was considered while promoting consistency of test methods between multiple vaccines. In 2022, the ATT (Abnormal toxicity test) of several products was deleted from in MRBP. In the future, we are continuing discussions, such as the study method from animal studies to in vitro studies. In addition, as the way of national test, a policy was shown that only SLP can be used for review of drug products that meet certain criteria. Regarding the difference in the organization (PMDA/the NIID) that evaluate CMC review for approval, the concept on the collaboration between PMDA and the NIID was clarified, and improvement of operations was promised. On the other hand, almost vaccines are required to be tested as actual test as national test, and it is hard to say that the double burden has been resolved yet. Imported products should be conducted national test in Japan, even if it was conducted same test as the national test in overseas. Multiple organizations are involved in the submission of test samples for national test, and coordination work among them is a burden on companies. Under the current regulations, one sample is picked up in the presence of prefectural government staff even when on the SLP-only review. In addition, because of this regulation, it is impossible to directly send samples to the NIID after sampling at the overseas manufacturing site, and lead time of supply of imported vaccines cannot be shortened. Actions to be taken in the SLP-only review are currently being discussed and considered for improvement. However, it is necessary to continue deliberations on the streamlining toward direct provision of samples and the way of national test under the SLP-only review. EFPIA Japan would like to request for more efficient national test, at least for products that have passed the national test in the US and Europe, such the SLP-only review is acceptable. In addition, it is very difficult to introduce vaccines that have been used for a long time in Europe, etc. because the information on biological raw materials contained in the Star-cell Bank/Master Seed does not meet the Standards for Biological Ingredients


  • To strengthen collaboration with PMDA/MHLW and the NIID during the approval review period , streamline the drug review and testing functions.
  •   Readjustment of the sampling method to allow sampling of test samples at overseas manufacturing sites.
  • To reduce the number of actual tests  and increase the number of products for SLP review only, including newly approved products.