The World Health Organization (WHO) and various international partners came together in Germany November 2006 to develop a task force focused on preventing the global spread of counterfeit medicines. The International Medical Products Anti-Counterfeiting Taskforce, or IMPACT would cover legal, technological, communications... Read More
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety... Read More
The Asian economy has experienced tremendous GDP growth over the past decade, and is expected to continue at a healthy pace for the next several years. In particular, the medical device market has been growing quite rapidly. More and more companies are... Read More
The Indian government has issued an order to change the Drugs Prices Control Order (1995) that will change the new maximum retail price (MRP) for drugs. Pharmaceutical companies will now have to comply with the new MRP system as of July 2006—all... Read More
The U.S. International Trade Commission will be conducting a fact-finding investigation into the competitive conditions in Japan and other foreign markets for medical devices and equipment. The investigation will focus on comparing the regulatory environment in Japan with those of other countries... Read More
In April 2006, the Chinese government opened a new Administrative Service Center to handle license applications for new medical devices and drugs in China more efficiently. This center, which is part of the State Food and Drug Administration (SFDA), will undertake administrative... Read More
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has announced cuts in reimbursement levels for drugs and medical devices that will go into effect on April 1, 2006. The revised reimbursement for drugs under the National Health Insurance program means an... Read More
In February 2005, the Malaysian Government decided to begin regulating medical devices. This new regulatory system for medical devices will be in accordance with the regulatory requirements of the Global Harmonization Task Force, World Health Organization, and World Trade Organization. The first... Read More
The Indian government has recently announced that its proposal for establishing a National Drug Authority will likely be in effect by mid-2007. According to India’s Minister of Health and Family Welfare, the legislation will soon be introduced to the Cabinet for approval.... Read More
Japan’s new Pharmaceutical Affairs Law (PAL), effective as of April 1, 2005, outlines the new post-marketing safety measures, also known as Good Vigilance Practice (GVP). This regulation clarifies the responsibilities of distributors of medical devices, drugs, quasi-drugs, and cosmetic products. All Marketing... Read More