Drug Evaluation Committee Handbook for Regulatory Requirements and Publications of Electronic Information
Electronic Standard for Medical Information Expert Committee
May 2025
The use of electronic data is indispensable in the development of pharmaceutical products and in various post-marketing operations, and the scope of operations using electronic data is expanding daily with the introduction of new systems and services. On the other hand, domestic and foreign regulatory authorities and industry associations have issued various regulations and proposals for systems and services using electronic data, and it has become difficult for individual companies to collect sufficient information.
Electronic Standard for Medical Information Expert CommitteeTask Force 4 has compiled a list of relevant regulations and issuances for each system or business in 2021, and has now prepared a fifth edition of the list with updated regulations and Explanation materials. The list includes links to the original information on the Internet and Japanese translations where available, so that information can be easily obtained. We hope that this document will be of help to your company in collecting information.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 4