Regulatory Affairs Committee

Confirmation of the operational status of the measures agreed upon by the "Review Committee" and proposal of measures to resolve issues

Proposal of measures to improve efficiency of review, investigation, consultation process, etc. and to contribute to early access to patients, and examination from a pharmaceutical perspective of improving efficiency of clinical trial environment including international consistency

Propose measures to eliminate drug lag/loss (proposals for pharmaceutical affairs processes, support for overseas offices of the Pharmaceuticals and Medical Devices Agency (NIH), etc.)

Recommendations and implementation of measures to achieve an internationally harmonized pharmaceutical affairs system (approval documentation, change procedures, and GMP investigations)

Actively participate in discussions for future revision of the Pharmaceutical Affairs Law and ensure compliance with the law.

Recommendations and implementation to achieve an internationally consistent pharmaceutical system (description of approval documents, change procedures, and GMP investigations) Exchange opinions with related industry associations, academia, and authorities (MHLW and PMDA) on the need for Japanese data in the approval process (the need for Japanese Phase I studies when participating in global clinical trials and the need for Japanese data in validation studies, etc.) and make recommendations and proposals.

The WGs and SWGs for review, clinical trial consultation, investigation, etc., as well as the WG for international joint clinical trials will discuss issues regarding proposals for measures to improve the efficiency of the review, investigation, consultation processes, etc., and to contribute to early access to patients. In addition, the WG will closely monitor trends in the regulatory environment, including new modalities associated with technological advances and software compatible with healthcare data, and will raise any issues and discuss them with the MHLW and PMDA in the relevant WGs and SWGs.

Explain the status of implementation and issues at regulatory science meetings and other public forums.

The Review WG will mainly review application materials and examine and make recommendations for a more efficient review process for each system currently in operation, and will organize issues based on the questionnaire survey on the status of review to be conducted in 2026 and propose improvements to MHLW and PMDA.

The Clinical Trial Consultation WG will examine the results of the face-to-face advice survey conducted in 2025, and make recommendations on the operation of a higher level of clinical trial consultation.

The Investigation WG will continue to study how reliability surveys should be conducted incorporating the risk-based approach, make recommendations for the review of notifications, etc., and, with the implementation of electronic data submission for applications, study efficient reliability survey methods utilizing the submitted electronic data. The WG will also continue to discuss the use of system audits that are not item-specific.

The Attached Documents WG will discuss how attached documents should be and what should be included in them, since the revised Pharmaceutical Affairs Law will make attached documents electronic and enable appropriate information to be provided based on clinically valuable evidence and the latest scientific findings, such as in long-term administration studies.

The Global Clinical Trials WG will continue to discuss "necessity of Japanese data for approval review (necessity of Japanese Phase I trials for participation in global clinical trials and necessity of Japanese data for validation studies, etc.)," an issue addressed at the "How it should be done" meeting.

The Clinical Trials SWG will work with the MHLW and PMDA to resolve issues related to the Single Patient IND system, satellite trials, and other clinical trial systems being discussed in the clinical trial ecosystem project.

The SWG for Non-clinical Issues will work with MHLW and PMDA to examine the operation of the documentary conformity survey (quality and non-clinical).

The SWG for Electronic Data Submission will discuss with MHLW and PMDA to resolve issues related to the operation of electronic data submission.

For other important issues, the SWG and TFs will be established to discuss them.

Participate in the Drug Lag/Loss TF to identify regulatory issues and propose measures to eliminate drug lag/loss.

In the operation of PMDA's overseas offices, the implementation of the Reliance Pathway, etc. will be discussed.

Ensure appropriate descriptions in the approval documents in order to achieve international consistency in pharmaceutical regulations and to ensure that approval items are consistent not only from the perspective of improving efficiency and productivity of corporate activities, but also from the perspective of preventing recurrence of quality-related incidents.

Make recommendations on the procedural system for post-approval change management, especially to reduce concerns about stable supply when changes occur, together with the relevant Committee and related industry associations, to achieve an internationally consistent system (study for the full revision of the February 10 Notice).

Identify issues for further internationalization of the Japanese inspection system in line with the internationalization of the GMP inspection system, including the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S), and cooperative inspections by the International Cooperation of Medicines Regulatory Authorities (ICMRA), and study and make recommendations on how to resolve such issues.

In order to achieve the "ideal state" presented by the "Study Group" for a stable and continuous supply of high quality pharmaceutical products, the committee will collaborate with related Committees and related industry associations to make proposals and requests for a system that can be reflected in future revisions of the Pharmaceutical Affairs Law (further internationalization of the GMP survey system, rationalization of the existing system, etc.). (e.g., further internationalization of the GMP survey system and streamlining of the existing system).

Actively discuss with academia and authorities (MHLW and PMDA) the future pharmaceutical affairs system and its operation methods through presentations at various academic conferences, submission of papers, and other public forums.