Pharmaceuticals and Medicinal Devices Agency (PMDA): History, Structure and Vision

April 2012

The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory agency in Japan that is responsible for the review and monitoring or products for medicinal use. The PMDA mission is to protect the public health by assuring the safety, efficacy and quality of pharmaceuticals and medical devices. PMDA is responsible for the scientific review of clinical trial applications and market authorization applications for pharmaceuticals, biologics and medical devices. The PMDA also monitors the post-marketing safety of medical products on the Japanese market. The PMDA works under the Ministry of Health, Labor and Welfare (MHLW), which is the agency in Japan that is responsible for most aspects of public health and the medical system in the country.

In its current structure, the PMDA is a relatively young organization and was formed out of the merger of several other government agencies in April 2004. Prior to 2004, medical products in Japan were regulated under several different agencies; The Pharmaceutical and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO) and in part the Japan Association for the Advancement of Medical Equipment (JAAME). The consolidation of these agencies to form the PMDA followed the Reorganization and Rationalization Plan for Special Public Corporations in 2001 and was part of a large government reorganization effort.

The structure of PMDA was established to facilitate the scientific review of medical products and to promote the development of medical science. The Chief Executive of the PMDA is the top official and has reporting to them the Audit branches and three Executive Directors. The Senior Executive Director is responsible for the divisions of PMDA that oversee safety, pharmacovigilance, information technology and compliance. The second Executive Director is responsible for the financial management, planning and coordination of the PMDA. The final Executive Director is responsible for the medical product review divisions. Within this organization there are separate groups for project management, science, drug review, biologics review and device review.

The primary mission of the PMDA is to review both clinical trial applications and marketing authorization applications for new products entering the market. This includes scientific reviews of pharmaceuticals, biologics and devices to ensure compliance with the requirements set forth in the Pharmaceutical Affairs Law (PAL) of Japan as well as PMDA, ICH and other agency guidelines that govern medicinal product reviews. PMDA also provides consultation to companies seeking to develop or gain approval of medicinal products in Japan. Their role is also to enforce GXP requirements and guidelines and to perform reevaluations and reexaminations of products under the PAL.

PMDA also plays a key role in monitoring the safety of medicinal products in Japan. The safety group within the PMDA is active at collecting data, analyzing and disseminating this information to ensure the safety and quality of products on the market in Japan. This group also provides advice to marketing authorization holders (MAH) to ensure that they are adequately monitoring and addressing safety issues with their products. The safety group of the PMDA also performs research related to their missing to monitor the safety of medicinal products.

PMDA also has a more humanitarian role in helping to provide medical aid and support to patients and families in need. In this role the agency has the funding to provide healthcare support to patients. They also support international programs through ICH, bilateral relationships with other key countries, mutual recognition efforts and other international programs to consolidate the worldwide drug approval process and harmonize these efforts to bring quality drugs and medicinal products to the market in Japan.

The vision of the PMDA is defined and implemented through a series of 5-year plans. The current Plan for the PMDA is for the period from September 2008 to 2013. This current plan focused on five key objectives. These key objectives include:

• Improving the Operational Efficiency of the PMDA by creating more cooperation between groups within the PMDA as well as supporting international programs for collaboration and harmonization among different national Agencies.
• Seek outside recommendations and opinions on how to improve the PMDAs review process as well as provide additional service to the public.
• Promote relief services for adverse health issues by informing the public rapidly of adverse health issues and by reducing the administrative hurdles to getting patients appropriate care.
• The PMDA is also focused on ways to reduce the review time for medicinal products from 12 months (FY2008 goal) to 9 months (FY2013 goal).
• PMDA is also focused on the effort to prevent adverse drug reactions by ensuring consistency in the review process, monitor safety of products on the market and enhancing information databases.

Thus the PMDA is a young and evolving Agency, but at the same time has an enormous responsibility within the healthcare system in Japan. As the PMDA matures and works in the international community to harmonize the review process for medicinal products, the pathway to approval and global development of drugs will become easier and more possible in Japan. Thus Japan will be an equal partner with the United States and Europe in the medicinal product review process and will continue to improve their capability and efficiency in the coming years.

Richard E. Lowenthal, MSc MBA
Pacific-Link Consulting LLC (San Diego and Tokyo)