Drug Evaluation Committee Handbook for Regulatory Requirements and Publications of Electronic Information
Electronic Information Subcommittee
May 2025
The use of electronic data is indispensable in the development and post-marketing operations of pharmaceutical products, 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.
Task Force 4 of the Electronic Data and Information Subcommittee prepared a list of related regulations and issuances for each system or service in 2021, and has now prepared a fifth edition of the list with updated related regulations and explanatory 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, Committee on Drug Evaluation
Electronic Information Subcommittee Task Force 4
Deliverables of the Drug Evaluation Committee Return to list of all deliverables