Regulatory Reforms
Nishimura & Asahi / Japan
The key facts about regulatory reforms in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
There is no significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, changes due to technology, telemedicine, apps as a medical device and enactment of Healthcare Big Data Act, and changes due to compliance issues, promotion guidelines and monitoring, and enactment of Clinical Trial Act.
2. When are they likely to come into force?
Small changes and developments are continuously occurring.