Japan's complex medical marketplace has been significantly deregulated in the past several years. The government has also taken some measures to be more open to foreign businesses, thus allowing more foreign companies to enter Japan's medical market. Several business and regulatory strategies... Read More
The higher costs associated with conducting clinical trials in Japan is forcing many of Japan’s top pharmaceutical manufacturers to perform their clinical studies in other countries. This has resulted in the reduction of the number of clinical trials performed in Japan. Contract... Read More
Good Manufacturing Practice (GMP) standards were initially introduced in China in 1992. The standards provide basic rules and requirements pharmaceutical manufacturers in Mainland China must abide by in order to ensure the quality of drug products. In order to obtain GMP certification,... Read More
In late October 2003, Singapore’s Ministry of Health announced the drafting of a new bill that would regulate research and collection of human stem cells and tissue. The draft law called the Regulation of Biomedical Research Bill has been placed on the... Read More
Malaysia’s Health Ministry is currently formulating a new legislation which will ban door-to-door direct sales of medicines. Consideration for the new law emerged out of the recent deaths of two siblings from the state of Johor after consuming illegally produced herbal tonics... Read More
The Institute of Nuclear Medicine & Allied Sciences released a proposal to the Indian government in the summer of 2003 to establish a system to regulate and supervise medical devices in the country. Currently, India does not have a regulatory body to... Read More
The ASEAN (Association of Southeast Asian Nations) Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 by the ASEAN Economic Ministers. The purpose of the committee is to eliminate technical barriers to trade and facilitate the objectives of the ASEAN... Read More
Drug-eluting stents (DES) are designed for the controlled release of drugs into surrounding tissue. These types of stents are particularly useful in preventing the re-narrowing of arterial walls, or restonosis, after cardiovascular procedures. This technology was recently introduced into the Indian medical... Read More
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