The CDSCO has recently published on their website the “National List of Drug Manufacturers / Loan Licensee and Certificate of Pharmaceutical Product (COPP) Holders,” the “National List of Approved Testing Laboratories,” and the “Capacity of Testing Laboratories under the CDSCO.” The first... Read More
The Drug Controller General of India (DCGI) will begin inspecting importers’ overseas manufacturing facilities to ensure compliance with standard industry practices. Despite having established provisions for such inspections in the Drug and Cosmetic Act, this is the first time the DCGI will... Read More
After a rash of incidents leading to patient deaths in Hong Kong hospitals in 2009, a review committee has developed 75 recommendation points aimed at improving the safety of prescription drugs. Under the Food and Health Bureau (FHB) and Department of Health... Read More
The Ministry of Health (MOH) in China issued new regulations in mid-January 2010 to increase supervision of medical devices in China. Larger hospitals will be required to set up committees to oversee and manage medical device use. In addition, the MOH hopes... Read More
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
China’s State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for sterile and implantable medical devices. All of these regulations... Read More
The Drug Controller General of India (DCGI) plans to revive the pharmacovigilance program initially launched in 2004, after holding a workshop on December 29 and 30, 2009. About 20 centers were open to record adverse drug reactions but the program has been... Read More
China’s State Food and Drug Administration (SFDA) issued new plans for ensuring the quality of essential drugs on November 25, 2009. All provincial food and drug administrations will need to focus on strengthening essential drug production and quality control supervision work. They... Read More
India’s Central Drugs Standard Control Organization (CDSCO) is increasing its supervision on spurious medical products by conducting a nationwide survey to assess the extent of availability of spurious drugs. They have drawn samples from different regions and these samples are currently being... Read More
More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be... Read More