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
Japan ’s New Pharmaceutical Affairs Law, effective as of April 1, 2005, outlines new Good Clinical Practice (GCP) guidelines, including the specific requirements for informed consent and privacy statements. Previously, a verbal informed consent by the study participants was acceptable, but 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
New IVD regulations are being developed throughout Asia. In Korea, before IVDs are permitted to enter the Korean medical market, these products require approval by the Korean Food and Drug Administration through a process similar to the pre-market approval (PMA) process for... Read More
As of December 1, 2005, the China State Food and Drug Administration (SFDA) began allowing the sale of drugs on the internet. The Interim Requirements for the Examination and Approval of Internet-based Pharmaceutical Trading Services, issued by the SFDA in October 2005,... 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
The Japanese Ministry of Health, Labor, and Welfare (MHLW) recently announced its plans to reduce medical insurance coverage for some of its elderly population. Under the new measure, seventy to seventy-five year old citizens who are not in the higher income bracket... Read More