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
Although China is making efforts to improve piracy and counterfeit drug enforcement mechanisms, pharmaceutical companies must still be extremely careful in the Chinese market. In fact, currently several large US pharmaceutical companies are facing significant challenges dealing with counterfeit drugs in China.... Read More
In 2003, Hong Kong’s Department of Health (DOH) launched the Medical Device Administrative Control System (MDACS). The first phase of the MDACS, which began on November 26, 2004, permitted medical device companies to voluntarily list their Class IV (high-risk) medical devices. The... Read More
For the most part, up until recently, only foreign medical companies that manufactured medical products in China could set up their own sales office and distribution scheme in China. However, after joining the WTO in December 2001, China agreed to open up... Read More
The Korea Food and Drug Administration (KFDA) has continued its efforts on harmonization of medical device standards with the enactment of medical device Good Clinical Practice (GCP) regulations on July 14, 2005. Previously, GCP regulations were not established for medical devices in... Read More
The Chinese State Council enacted new regulations on the control of narcotic and psychotropic drugs (Chinese State Council Order No 442, August 3, 2005) that went into effect from November 1, 2005. These new regulations, which replace the pre-existing Narcotics and Psychotropics... Read More
A draft of Malaysia’s Medical Device Bill has been completed and submitted to the Attorney General for review, according to a statement made by Malaysian Minister of Health Dr. Chua Soi Lek in September 2005. One of the requirements in the proposed... Read More