On December 7, 2011, China’s Cabinet approved a blueprint to boost the country’s drug safety over the next five years. Measures to improve drug safety include increased monitoring of pharmaceutical companies and a new credit rating system. The 2011-2015 plan sets the... Read More
China's pharmaceutical market is currently the ninth largest worldwide and worth approximately $25 billion. With analysts predicting this market to be the fifth largest by 2013, one cannot ignore China's potential. This webcast will provide an overview of drug registration in China... Read More
China’s State Food and Drug Administration (SFDA) is planning to start a new drug GMP inspection program. Under the pilot program, officials from SFDA’s GMP department will visit a total of 10 overseas manufacturing facilities, concentrating on vaccines, biologics, and active pharmaceutical... Read More
The Chinese State Administration of Food and Drug (SFDA) recently issued a Tentative Guidance for the Monitoring of Adverse Device Events. The document outlines how manufacturers, distributors, and suppliers of medical devices should report and monitor adverse events. The new guidance establishes... Read More
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