Japan’s PMDA Proposes International Strategic Plan

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has discussed with the Ministry of Health, Labor and Welfare (MHLW) on how to implement international activities for pharmaceuticals and medical devices in the future. They have formulated a framework for international activities and posted their proposal recently on the PMDA website. This International Strategic Plan outlines policies and objectives to be achieved during the coming second mid-term plan period (from FY 2009 to 2013).

One of the main goals is to further strengthen the partnerships with regulatory agencies in the US and EU. The PMDA hopes to have a rapid exchange of information through the promotion of executive-level talks with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). The PMDA will promote bilateral talks based on information sharing and proactive personnel exchanges. It plans to deploy staff members to the FDA and EMEA, regularly invite personnel from the two organizations to its offices, and establish a system under which detailed information can be gathered and opinions can be exchanged in real time. The PMDA will swiftly analyze, execute, and translate important overseas information and communicate it to the relevant parties.

Other plans include maintaining and developing initiatives led by Japan, the US, and the EU including the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Another goal is to create partnerships with regulatory agencies in Asian countries through information exchanges. Proposals include strengthening of cooperation with China and South Korea through director-general level meetings concerning pharmaceutical affairs.

The PMDA will also strengthen cooperation with foreign countries with respect to inspections and audits conducted to ensure compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GCP), and Quality Management System (QMS).

The PMDA plans to foster internationally minded human resources with communication skills. They will promote the development of staff training programs such as communications with overseas parties, attendance and presentations at international conferences and meetings and implement such programs in an organized manner. PMDA will also work to help relevant staff members improve their foreign language skills, such as English, by continuing and strengthening its foreign language training and daily educational actives for directors and staff members.

PMDA also plans to improve and enhance its English website and to prepare and disclose more English translations of regulations and updates.