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
The National Development Corporation (NDC), the investment arm of the Philippines Department of Trade and Industry, announced in October 2005 that it would raise P100 million (approximately US$1.8 million) in funding for the government’s national drugstore program. Through this program, which is... Read More
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has issued guidance (Notification 0715006, July 2005) on GCP compliance reviews of clinical trial documentation for medical device shonin applications. Both the MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA), the consultative... Read More
Vietnam ’s new Pharmaceutical Law, approved by the Vietnamese National Assembly in May 2005, will go into effect October 1, 2005. The Pharmaceutical Law addresses the development of the domestic pharmaceutical industry and State control over drug pricing, in addition to other... Read More
The Ministry of Health in Malaysia has issued further guidance on the requirement for all registered pharmaceutical products to be labeled with a Meditag, a hologram security device. The Meditag was initiated by the government in an effort to combat the flood... Read More
The Japanese Ministry of Health, Labor and Welfare recently issued an update to Notification No. 0709004, released last year, which outlined the dossier requirements for obtaining a foreign manufacturer certificate. According to the 2002 Pharmaceutical Affairs Law (PAL), any foreign medical device... Read More
Following the implementation of the New Pharmaceutical Affairs Law (PAL) in Japan on April 1, 2005, foreign companies registering and marketing their products in Japan should be aware of the new regulatory changes that have taken place. These changes include the new... Read More
Malaysia’s healthcare sector, including pharmaceuticals and medical devices, is one of the country’s largest industries, valued at around $1 billion. Currently, Malaysia has over 250 private medical facilities, and the country’s medical market is growing at an annual rate of 6-7 percent.... Read More
Vietnam ’s population totals around 84 million and its economy boasted a 7.7 percent GDP growth rate in 2004. While Vietnam’s healthcare industry is still developing, it is one of the faster growing markets in the global healthcare industry. In 2003, Vietnam... Read More