Japan’s Ministry of Health, Labor and Welfare (MHLW) is aiming to revise the Pharmaceutical Affairs Act (PAA) to expedite approval of for tissue-engineered medical products (TEPs). The MHLW is considering a new system that would create an exception for TEPs in terms of the number of required clinical trials.
Existing PAA regulations can require hundreds of clinical trial cases depending on the situation. The proposed revisions would require around ten cases for TEPs. The MHLW will also seek to clarify the definition of TEPs as opposed to conventional medical products. Generally speaking, TEPs are products that incorporate cells, biomaterials, and biomolecules, but there is no rigid definition in Japan at the moment.
Although the MHLW seeks to expedite approval for TEPs, it will require strict informed consent from clinical trial patients and detailed post-marketing follow-up to maintain product approval. As a result of these changes, clinical trials for pharmaceuticals using TEPs are expected to take only 4-5 years as opposed to the present 10 years.