Further improvement of national test process and international harmonization of regulatory requirements

As a result of long-standing discussions among industry, academia, and government, the national test process in Japan is gradually improving. As a way of national test, a policy was also presented that formulations that meet certain criteria could be examined only by SLP, and several products that were accepted for SLP-only examination in accordance with the standards were also selected. On the other hand, many vaccines are required to be tested by the national standard, and it is still difficult to say that the double burden has been resolved. Imported products are exported from the country of origin after undergoing their national test, but even after importation, Japan's national test system often requires that Japan conduct tests again in accordance with Japan's unique biologics standards. The submission of test samples for national test involves the National Institute of Infectious Diseases (NIID), the MHLW, and prefectural officials, and the coordination work is a burden on companies. Even in the case of paper-only testing using SLP, the revision of the Pharmaceuticals and Medical Devices Act proposes that the presence of prefectural officials is not required for sample extraction, but the method of sampling is basically sampling in Japan, and we believe that it is necessary to review the inefficient system. For example, if it is possible to randomly sample vaccines in advance at overseas factories and send them directly to the NIID, the lead time for the supply of imported vaccines will be shortened. Discussions continue to be held on how to improve the efficiency of direct provision of specimen samples and how to conduct national testing for SLP only.  On the other hand, it is necessary to discuss and confirm new operational changes to whether or not the national test will be necessitated by the Japan Institute for Health Security (JIHS), which will be established in April 2025. In addition, it is necessary to discuss whether the method of pre-approval inspection should really be a requirement for approval, or whether it will be abolished, and a new framework will be established if only technology is to be transferred to prepare for national test. EFPIA Japan VWT will continue to request that products that have passed at least the national test in Europe and the United States be examined only by SLP, and that the national test be made more efficient, such as streamlining the submission of samples. In addition, regarding the fact that it is very difficult to introduce bio-derived raw materials in Japan because the information on bio-derived raw materials contained in the Master Cell Bank/Master Seed of vaccines that have been widely used in Europe and other countries for a long time does not meet the bio-derived raw material standards, 4 Dantai, including EFPIA Japan VWT, has proposed a review of the bio-derived raw material standards, and AMED research groups are currently discussing them. Exemptions for vaccines with a clinical track record of 20 to 30 years have been formulated and studies are underway to make it possible to apply them.