As part of the extensive Pharmaceutical Affairs Law (PAL) revisions in Japan, the Japanese government has instituted changes to their current regulations in order to consolidate safety measures for biological products. The regulatory changes for biological products were introduced in July 2003.... Read More
Singapore’s Health Sciences Authority (HSA) has been developing an electronic licensing system to support the regulatory functions of the Centre for Pharmaceutical Administration (CPA) since 2001. The HSA implemented the first part of its electronic system in April 15, 2003 with the... Read More
The Malaysian National Pharmaceutical Control Bureau (NPCB) regulates the registration and authorization of manufacturing site changes for pharmaceutical production. There are five types of manufacturing site changes. Type I: Change of manufacturing site within Malaysia As a result of upgrading of facilities... Read More
A recent survey conducted by the Political and Economic Research Consultancy (PERC), a Hong Kong based research group, gave South Korea 5.88 points on a scale of 0 to 10 for intellectual property (IP) protection (0 being the highest level of IP... Read More
On May 14, 2002, Singapore’s Health Sciences Authority (HSA) and its Australian counterpart, the Therapeutic Goods Administration (TGA) signed a Memorandum of Intention of Cooperation (MOI) laying out its intentions to jointly collaborate and cooperate in their regulatory framework for pharmaceuticals, medical... Read More
In early April 2003, the Japanese government took its first steps towards granting patents to medical procedures. A council for the Ministry of Economy, Trade and Industry drafted a plan that would allow patents to be granted for medical techniques associated with... Read More
Japan’s recent food-related scares have prompted the Japanese government to take more serious measures in addressing the country’s food safety. Last year, Snow Brand Food Products Co., was involved in highly publicized scandals involving the distribution of foreign meats labeled as domestic... Read More
The National Trade Estimate (NTE) Report released in April 2003 by the Office of the US Trade Representative (USTR) recently criticized South Korea’s trade barriers and lack of communication between the Korean government and multinational pharmaceutical companies. Based on the strong language... Read More
In an effort to prevent and reduce errors in administering medication, Taiwan’s Legislative Yuan (Council) ratified a revision of the Pharmacy Law on January, 14, 2003, requiring that all medicines sold in Taiwan must have labels in Chinese. Due to increased instances... Read More
The Chinese government announced on March 6, 2003 a radical restructuring of several government bureaucracies. Among the government bodies that will undergo drastic change will be the Ministry of Health, Ministry of Commerce, and Ministry of Foreign Trade and Economic Cooperation. The... Read More