To strengthen the supervision of pharmaceutical companies in China, the State Food and Drug Administration (SFDA) issued the Interim Provisions for Drug Safety Credit Classification on September 13, 2004. The new regulation will categorize domestic and foreign drug companies, including manufactures, distributors,... Read More
Beginning June 7, 2004, the China National Development and Reform Commission (NDRC) implemented new price caps on over 400 domestic and foreign made pharmaceuticals, reducing drug prices by as much as 50%. This is the government’s latest effort to reduce irregularities in... Read More
In a move to address antibiotic abuse in China, the Ministry of Health and the State Food and Drug Administration (SDFA) issued a new regulation, effective July 1, 2004, limiting the purchase of antibiotics to patients who have received a doctor’s prescription.... Read More
On August 9, 2004, China State Food and Drug Administration (SFDA) issued new regulations for the registration of medical devices in China. These new regulations will simplify the application and dossier review process for medical devices. Additionally, the Medical Device Clinical Trial... Read More
With the growth of Asian economies spurring on the expansion of Asian medical markets, medical and pharmaceutical companies in the West are increasingly looking to Asia for outsourcing. Western medical device and pharmaceutical companies have begun to outsource research and development, clinical... Read More
In response to concerns about the safety and effectiveness of pharmaceutical manufacturing in China, the State Food and Drug Administration (SFDA) will require Good Manufacturing Practice (GMP) authentication for all Chinese pharmaceutical manufacturers. The regulation goes into effect on July 1, 2004,... Read More
From July 1, 2004, the sale of over the counter antibiotics will be severely limited in China. Antibiotics not included in a list of legitimate OTCs can only be sold with a doctor’s prescription. Popular drugs like penicillin and sulphonamide, now commonly... Read More
The Drug Import Regulation, issued by the State Food and Drug Administration and in effect since January 1, 2004, allows for the faster sale of imported medicine. Imported drugs can now be sold immediately upon clearing customs. Previously, the sale of imported... Read More
While other countries debated questions of ethics dealing with genetic engineering and research, China has been seen as a country which welcomed any type of genetic research with no questions asked. However, this previously held belief is changing. On October 1, 2003,... 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