US and Japan Commit to Regulatory Reform and Economic Cooperation

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.

  1. The PMDA will respond timely to drug clinical trial consultations in an
    effort to reduce the wait time for consultations.
  2. 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.
  3. The number of drug reviewers will be increased and their quality and consistency
    improved, in an effort to improve the drug review time.
  4. Drug and medical device industries may provide input on issues related to
    reimbursement before policy decisions become finalized.
  5. 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.