PMDA

We are working on expanding the PMDA's review system. We also aim to further promote the practical use of innovative medical devices.

Implemented rapid approval review, operational review, web-based responses, and shortened review periods for medical devices and in vitro diagnostics related to COVID-19.

Thank you for your cooperation in the rapid review and post-marketing safety measures for medical devices and in vitro diagnostic drugs. Following last year, all target review periods for medical devices and in vitro diagnostic drugs were achieved.

Describes efforts such as shortening review periods for medical devices and in vitro diagnostics, introducing an online application system, promoting approval of software medical devices, full-scale operation of MDSAP, and applying for membership in GHWP.

Description of efforts and system improvements related to approval and review periods for medical devices in response to the novel coronavirus infection.

Based on amendments to the Pharmaceuticals and Medical Devices Act, efforts include reviewing the approval and certification system for medical devices, introducing new systems, promoting expedited reviews, responding to COVID-19, strengthening international relations, certifying the Asia Training Center, and promoting collaboration with overseas entities.

Explanation and exchange of opinions regarding revision of review fees, system operation, and regulatory review.

The 7th World Pharmacopoeia Conference was held in Japan.

PMDA was approved to hold seminars on multicenter clinical trials/GCP inspections scheduled in Tokyo in January and February 2017, and on drug and medical device safety monitoring.

PMDA will host a pilot seminar as a Good Practice training center for the Multi-Regional Clinical Trial / GCP Inspection Roadmap and the Pharmaceuticals and Medical Devices Safety Surveillance Roadmap. PMDA will play a central role in training regulatory authorities and related personnel in the APEC region in these areas.

The Ministry of Health, Labour and Welfare / PMDA secures veto rights on major decisions at the general meeting and management committee, and is a permanent member of the management committee.

Preparation and adjustment of operations in response to amendments to the Pharmaceuticals and Medical Devices Act, issuance of notifications, review of regulations, designation of specific medical devices, introduction of conditional approval system, extrapolation of clinical data, implementation of the IDATEN system, streamlining of medical device regulations, promotion of electronic processes, review of adverse event reporting scope in clinical trials, promotion of international harmonization, promotion of international joint clinical trials for regulatory harmonization, strengthening collaboration with overseas regulatory authorities.

Explanation and exchange of opinions regarding revisions to review fees and system improvements.