Regulatory Affairs Committee

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

Propose measures to improve efficiency of review, investigation, consultation processes, etc. and to contribute to early access to patients, and study from a pharmaceutical perspective to improve the efficiency of the clinical trial environment, including international harmonization

Proposal of measures to eliminate lag lag/loss (proposal of pharmaceutical affairs processes, support for overseas offices of the Pharmaceuticals and Medical Devices Agency (PMDA), 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.

Investigate trends in the operation of the Pharmaceutical Affairs Law after the issuance of the notification by means of questionnaire surveys, etc., regarding the early designation of drugs as orphan drugs, promotion of pediatric drug development, and the necessity of Japanese data in the approval review process (necessity of Japanese Phase I studies when participating in international joint clinical trials and necessity of Japanese data in verification studies, etc.) discussed by the "Review Group on the Role of the Pharmaceutical Affairs Law", and ensure compliance with the relevant industry regulations. The committee will also exchange opinions with related industry associations, academia, and authorities (MHLW and PMDA), and make recommendations and proposals.

Review issues in each WG and SWG of review, clinical trial consultation, investigation, etc., and international joint clinical trial WG, etc., as necessary.

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 the various systems currently in operation, organize issues based on the questionnaire survey on the status of review to be conducted in 2025, and propose improvements to PMDA and MHLW.

The Clinical Trial Consultation WG will conduct a questionnaire survey of member companies of the Pharmaceutical Affairs Committee and PMDA regarding the implementation status of face-to-face advice, exchange opinions on the results, propose improvements, and make recommendations for 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 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 study 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.

The SWG and TFs will be established to discuss other important issues.

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

Discuss the implementation of the Reliance Pathway in the operation of PMDA's overseas offices.

To achieve internationally consistent regulatory approvals from the perspectives of international consistency of pharmaceutical regulations, efficiency and productivity improvement of corporate activities, and prevention of recurrence of quality incidents, and to ensure appropriate descriptions in the approval documents.

Make recommendations on the procedural system for change management after approval, especially to reduce concerns about stable supply when changes occur, together with the relevant committees and related industry associations, and achieve an internationally consistent system.

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

In order to achieve the "ideal state" presented by the "Study Group" and to propose a system that can be reflected in future revisions of the Pharmaceutical Affairs Law (further internationalization of the GMP survey system and rationalization of the existing system, etc.) in order to ensure a stable and continuous supply of high-quality pharmaceutical products, the committee will work with related committees and relevant industry groups to study and make (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 public presentations at regulatory science conferences, submission of papers, and other public forums.