The State Food and Drug Administration (“SFDA, the Agency”) issued an order in late December 2010 to require compulsory incorporation of a monitoring bar code issued by the agency in the direct packaging materials of compound pharmaceutical formulations containing ephedrine, codeine and diphenoxylate, in order to prevent abuse and misuse of such products. Manufacturers of these products must add these types of products to SFDA’s electronic database by December 31, 2011 and their distributors should strictly control inventory flow. These special compound pharmaceutical products, if not registered in SFDA’s electronic database nor bearing the monitoring bar code by January 1, 2012, cannot be sold in the market. Approximately 200 products are subject to this order, which include popular OTC brands like Contac NT.
SFDA issued 96 new product standards governing medical devices in late December 2010, 34 amongst which are mandatory. These new product standards will be effective on June 1, 2012. Products affected under these new standards include medical equipment (e.g. hemodialysis equipment, radio frequency hyperthermia equipment, and ultrasound bone densitometer), instruments for dental, ophthalmic and surgical uses, surgical implants (e.g. hip and knee joint endoprostheses), and reagents (e.g. test kits for tumor markers).
SFDA issued Supplemental Rules on the Regulatory Dossiers for Functional Foods (“Supplemental Rules”), which will be effective on February 1, 2011. The Supplemental Rules state detailed requirements concerning sensory descriptions, examination methods, physical/chemical criteria, descriptions of functional ingredients, dosage/method of use, shelf life and storage conditions. Furthermore, the Supplemental Rules stipulate that the validity period for testing reports included in the regulatory dossiers for functional foods shall not exceed 5 years.
As an important initiative of public hospital reform, the Ministry of Health (“MOH”) announced regulations which allow healthcare service providers from Hong Kong, Macau and Taiwan to establish wholly owned private healthcare institutions in Mainland China, effective since January 1, 2011. Specifically, healthcare service providers from Hong Kong and Macau can establish wholly owned private healthcare institutions in Shanghai, Fujian, Guangdong, Hainan and Chongqing; they can also establish wholly owned private nursing homes in Guangdong. Healthcare service providers from Taiwan can establish wholly owned private healthcare institutions in Shanghai, Fujian, Guangdong and Hainan. These private healthcare institutions must meet the requirements applicable to Class II or Class III hospitals in Mainland China, with the amount of total investment no less than RMB 20 million (for Class II private hospitals) or 50 million (for Class III private hospitals). The incorporation of these private healthcare institutions shall be reviewed by MOH and approved by the Ministry of Commerce (“MOC”) (or registered with MOC if it is a non-for-profit healthcare institution).
The China Life Sciences Practice of Sidley Austin LLP
Sidley has a powerful, fully integrated life sciences practice serving multi-national pharmaceutical, biotechnology, medical device and food companies in every aspect of their business operations in China. Sidley’s Foreign Direct Investment, general Commercial, Corporate, M&A/Joint Venture, Antitrust, FCPA, Licensing, IP, provincial government work, as well our Regulatory practice permits us to serve virtually every legal need of our life sciences clients in China.
Sidley is the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. As an integral part of our Global Life Sciences practice, we bring our knowledge of industry practices in the U.S. and EU to each project in China and help develop global Standard Operation Procedures (SOPs) and benchmark best practices.
For further information on the China Life Sciences Practice, please contact: Chen Yang, Partner (+86.10.6505.5359,
); Zhengyu Tang, Partner (+86.21.2322.9318,
); or Katherine Wang, China Strategic Advisor (+86.21.2322.9303, +1.213.896.6141,
).
The Global Life Sciences Practice of Sidley Austin LLP
On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology. Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and leaders in various life sciences fields.
For further information on the Global Life Sciences Practice, please contact: Scott Bass (+1.202.736.8684, +1.212.839.5613,
) or James C. Stansel (+1.202.736.8092,
).
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