In March 2011, India achieved the status of full adherence to Good Laboratory Practices (GLP) certified by the Organization of Economic Cooperation and Development (OECD). The OECD is composed of the world’s most advanced countries such as the US, the UK, Canada,... Read More
Reintroduction of Medical Devices Regulation Bill (MDRB) In 2006, the MDRB was proposed by the Ministry of Science and Technology to consolidate laws related to medical devices and to establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed... Read More
Thailand is raising its quality control standards on local manufacturing of medical devices. According to Thai government officials, a medical device institute may be set up as a testing center for quality standards. New quality standards are also expected to be outlined... Read More
Pharmaceuticals China’s State Food and Drug Administration (SFDA) first issued the Good Manufacturing Practice (GMP) for Pharmaceutical Products in 1988 to regulate the quality of drugs that are made in China. This regulation was recently revised and the latest GMP regulation is... Read More
On January 19, 2011, newspapers in Japan published an announcement from the Ministry of Health, Labour and Welfare (MHLW) on an upcoming change to the good manufacturing practice (GMP) compliance audit. It had been previously announced that manufacturers creating products that are... Read More
In early November, the Chinese State Food and Drug Association (SFDA) initiated a joint inspection for drug safety by six government departments. After releasing the Notice on Distributing Special Action Plan for Cracking Down on Violations of Intellectual Property Rights and the... Read More
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