Increased Cooperation Between Japan, EU, Canada, and US

Japan’s Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission’s Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009.

The MHLW and the PMDA will cooperate with the European Commission to facilitate the sharing of documents and/or information related to ensuring the quality, safety and efficacy, as appropriate, of medical devices. The exchange of information could include but is not limited to:

  • Advanced drafts of pending laws, regulations, guidance documents, procedures and other technical documents available to the individual Participants related to medical devices
  • Post-marketing data and information that could have an impact on public health or information about impending regulatory actions
  • Information on quality defects or product recalls of products known by MHLW or PMDA to have been manufactured or distributed in the EU and vice versa

The information will be kept strictly confidential between the parties. This information exchange will also be extended to quasi-drugs, which are often regulated as cosmetics in the EU.

For Health Canada, parties will share information on therapeutic products.

The United States and Japan issued a report detailing the progress of the US-Japan Regulatory Reform and Competition Policy Initiative. The Initiative was established to encourage fairer competition, improve the business environment in Japan, and promote bilateral economic growth through regulatory reform. The two countries exchange recommendations on issues relating to various sectors annually. This year’s 86-page report to the leaders is the eighth under this Initiative and was presented to President Barack Obama and Japanese Prime Minister Taro Aso on July 6, 2009

The report shows that Japan and the US are committed to improving regulatory practices in wide range of sectors, including the medical devices and pharmaceutical industry. The recommendations of the Initiative aim to facilitate the introduction of innovative medical devices and technologies to the Japanese public and promote greater access for American companies into the Japanese medical market. The following points highlight the measures that Japan will take or have already taken in the medical sector in response to the recommendations in the report.

The PMDA will respond timely to drug clinical trial consultations in an effort to reduce the wait time for consultations.

A program will be implemented to expedite the medical device review process. This program will include hiring more medical device reviewers, providing them with extensive training, tracking their performance, and publishing review times for approvals.

The number of drug reviewers will be increased and their quality and consistency improved, in an effort to improve the drug review time.

Drug and medical device industries may provide input on issues related to reimbursement before policy decisions become finalized.

Members of industry and the US industry may provide input to the MHLW and its advisory bodies when major changes to the healthcare system are implemented.