Things change fast in China. In the past year, China has overhauled many aspects of its regulatory regime – changes that are having a major impact on how multinational pharmaceutical and medical device manufacturers do business in China. On March 11, the State Council of China announced the merger of the State FDA into the Ministry of Health, meaning that the MOH will now play a key role in regulating the life sciences industry, including coordination of enforcement actions and rulemaking.
For pharmaceuticals, new requirements for electronic tracking of certain products have gone into effect, with possible expansion in 2009 to include all drugs and medical devices marketed in China. SFDA also has issued new guidelines for post-approval manufacturing changes for marketed drugs, a rule describing how the agency and local FDA agencies will conduct inspections as part of the drug approval process, and for the first time a system has been established for drug recalls in China.
For medical devices, SFDA has published its second draft GMP regulations, along with draft certification and inspection procedures for device products. And on July 23 the agency published provisional rules that for the first time imposed joint liability on foreign device manufacturers and their Chinese agents for adverse event reporting, product recall and after-sales service.
In other areas, a new anti-monopoly law entered into force Aug. 1 that forces life sciences companies to pay particular attention to what could be defined as monopoly agreements in China and abuse of dominant market positions.
Are you ready to meet the challenges and opportunities presented by these regulatory changes? Learn what your company must do today to comply with China’s new drug and device regulations and policies. Plus, get a sneak peek at future regulatory changes that are on the way.