On the surface, Japanese GCP guidelines seem fairly standard and straightforward. Basic duties and requirements for the medical institution(s) at which trials are held, the physicians involved, the Institutional Review Board, and the Trial’s Sponsor are very similar, if not identical, to... Read More
Foreign companies looking to penetrate medical device markets in Asia need to pay close attention to the regulatory environment in order to handle the difficulties that await them. Japan's medical device market is the second largest market in the world, worth almost... Read More
China’s pharmaceutical market continues to grow by 10 to 15 percent per year. Many expect it to be the world’s largest pharmaceutical market by 2020, with sales topping US$60 billion by 2010. Imports from the U.S. accounted for 8.51% of the market... Read More
Vietnam imports nearly all the medical equipment and devices used domestically. As such, foreign firms interested in the Vietnamese market must understand the rules and regulations governing the import, sale, and distribution of medical equipment in that market. Although laws have been... Read More
Recent estimates indicate that there are over 3,000 health food products sold on the market in China, including nutraceuticals, functional foods, and products based on Traditional Chinese Medicine (TCM). At least one source reports that total sales volume in China’s health food... Read More
Effective January 14th, Japan’s Ministry of Health, Labour, and Welfare (MHLW) issued new guidelines for medical device packaging. “The Guideline of Package Insert for Medical Devices†aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent... Read More
In what many Western observers see as a misguided effort to contain rising healthcare costs, the State Development Planning Commission of China recently revived plans to institute price caps on the drug industry. The new regulations state that manufacturers may sell patented... Read More
Foreign pharmaceutical companies control at least 75% of the local drug market in the Philippines. Foreign firms’ market share is divided between several countries, with U.S. producers accounting for about 10% of the market, and Switzerland, Germany, Australia, France, and the U.K.... Read More
The Korea Food and Drug Administration (KFDA) requires that all medical devices sold in Korea receive approval prior to market entry. In the past, if the foreign manufacturer was exporting to Korea, KFDA regulations stipulated that a local distributor, not the foreign... Read More
Malaysia’s Drug Control Authority (DCA), which was established under the Control of Drugs and Cosmetics Regulations 1984, is a government authority that ensures the safety, effectiveness and quality of cosmetic products marketed in Malaysia. The DCA is responsible for the registration and... Read More