Your Japanese Healthcare Market Specialists

REGULATORY GUIDANCE

KMG Japan consults on the Japanese Ministry of Health, Labour and Welfare (MHLW or “Kosei-roudou-sho”) regulations, the Drugs, Cosmetics and Medical Instruments Act, and regulatory application procedures to client companies, which has become a solid part of the business performance of the company. KMG Japan's key principal, Kyle Murphy, has personal and professional relationships with most of the key industry and regulatory officials in Japan. During the last 20 years, he has successfully helped many U.S. and Japanese companies launch their products overcoming the most complicated regulatory issues. KMG Japan has established a solid record bringing to the clients regulatory victories.

The results of International Conference on Harmonization (ICH), signed by the Japanese government in 1996, mark significant progress for Western pharmaceutical companies expanding to Japan. For foreign companies marketing global drugs, Japan was once a challenging environment whose policies necessitated great costs, largely from having to repeat expensive full-scale clinical trials in Japanese populations. Because of efforts toward regulatory harmonization companies can now submit foreign data and often can conduct only bridging trials in Japan, small-scale clinical trials designed to extrapolate a treatment's effects on a Japanese population. The Japanese government also boasts a streamlined new drug approval process. More recently, an amendment of the Pharmaceutical Affairs Law (PAL) was passed by the Diet in July 2002. Under the new regulatory system, the license based on possession of manufacturing facilities has shifted to conditionality on post-marketing safety measures. The approval system changed from awarding approval to manufacture to approval to put products on the market.

The Japanese market still differs noticeably from Western markets in many aspects of the regulatory area and continues to undergo significant changes. KMG Japan works with its clients to recognize the differences up front and to include them in business decision-making. KMG Japan can provide market research for its clients covering issues such as:

Regulatory briefings
Protocol development
Creation of approval strategy for efficient process and maximized
reimbursement price
Troubleshooting when something goes wrong
Sanity check on regulatory issues when dealing with your subsidiary
or partner

For more information on Regulatory Issues in the Japanese Healthcare Market, or on the services KMG Japan can provide on Regulatory issues, please send us your inquiry or contact us directly at: