DRW Monthly
October 2010
Issue No. 46

Japan's Global Clinical Trial Regulatory Initiative

Japan has been actively working to eliminate long-standing delays in its drug review and approval process for the past decade. Although the country has shortened the time it takes for drug products to reach the market from about three years in 2006 to one and a half to two years to date, Japan is still significantly lagging behind its US and European competitors.(1) Further compounding these drug approval challenges is the serious shrinkage in clinical trials conducted in the country. A growing number of domestic Japanese companies are electing to conduct their clinical trials in foreign countries due to the high costs and poor clinical research infrastructure, thereby contributing to this shrinkage and reducing the scope for outsourcing in Japan.(2)

Regulatory Background

The Japanese government launched a concerted effort to speed up the drug approval process when it established the Pharmaceuticals and Medical Devices Agency (PMDA) in 2001 and with its revision of the Pharmaceutical Affairs Law (PAL) in 2002. The PAL revisions laid down a basic structure for the review and approval of drugs before marketing, and were intended to address the numerous advances in medical product safety, quality and efficiency. In addition, shortly after the PMDA began its official service in 2004, a study committee on clinical trials was convened in 2005. The committee recommended that the agency become actively involved in international collaborative clinical studies as a strategy to improve the status of clinical trials in Japan. It also stressed the need for the PMDA to improve the overall framework by which clinical trials are conducted.(3)

These developments were subsequently followed by the PMDA's release of a new guideline entitled, "Basic Concept for International Joint Clinical Trials." The guideline was designed to provide opportunities for Japanese biopharmaceutical companies and global contract research organizations to work together to accelerate drug development in Japan. It also expanded the criteria for accepting clinical data from non-Japanese patients.

More recently, the PMDA introduced its five-year clinical trial activation plan in 2009 that set forth the following goals:

• Reinforce clinical research infrastructure to ensure safe and secured patients' access to new drugs and devices;
  
• Build a nationwide infrastructure to perform innovative and valuable clinical research in a smooth manner;
  
• Network core clinical research sites where skills and resources are highly integrated;
  
• Enhance the level of Japan's medical quality; and
• Penetrate Japan-originated clinical innovation in the world by enhancing the country's contribution to international multi-centered trials.(4)