India’s Department of Chemicals and Fertilizers, the administrative ministry for the pharmaceutical industry, recently released a draft of the National Pharmaceuticals Policy 2006. The draft was presented at the first meeting of the Pharmaceutical Advisory Forum on February 11, 2006. The draft... Read More
In accordance with the new Pharmaceutical Affairs Law (PAL), which went into effect on April 1, 2005, the Ministry of Health, Labor, and Welfare (MHLW) issued an update on Good Laboratory Practice (GLP) in Notification 0331030. This notification clarifies that GLP is... 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
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
New IVD regulations are being developed throughout Asia. In Korea, before IVDs are permitted to enter the Korean market, these products require approval by the Korean Food and Drug Administration through a process similar to the pre-market approval (PMA) process for medical... 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
Japan’s new Pharmaceutical Affairs Law (PAL), implemented on April 1, 2005, outlines a shorter and less complicated application procedure for Class I medical devices. Class I medical devices are not required to have each product shonin or ninsho approved by a notified... Read More
The Indian government has proposed the creation of a new agency to monitor and raise standards for clinical trials conducted in India. India’s Science and Technology Minister Kapil Sibal met with the U.S. FDA in August 2005 to request its assistance in... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) issued a new regulation on September 22, 2005, which outlined changes in the drug application process for new generic drugs containing one active ingredient. The application will now require pharmaceutical companies that apply for... Read More
In October 2005, the Indian Ministry of Health and Family Welfare issued notifications that essentially constitute the regulation of medical devices. The notifications amended the Drugs and Cosmetics Act of 1940 by reclassifying certain medical devices as drugs in order to bring... Read More