New Trends in the Pharmaceuticals, Medical Devices, Health Care and Life Sciences of China
Q: What’s the new policy regarding the health providers from Hong Kong and Macao?
A: It was forbidden for health providers from Hong Kong and Macao providing services in Mainland, however according to a notice issued by the Ministry of Health that Hong Kong and Macao health service providers may establish health institutions in mainland China since January 1st 2013. Providers are allowed to set up various kinds of health institutions in mainland China, such as wholly owned, jointly invested, or part of cooperative partnerships with other health establishments or enterprises, except for wholly owned hospitals or senior houses, the other forms of newly established entities will be subject to administrative approval by health authorities at the provincial level, rather than at the national level.
Q: What’s the new classification of medical devices?
A: China’s State Food and Drug Administration (SFDA) issued a notice on December 10, 2012, announcing the classification of 17 medical devices which were derived from expert advice provided to the SFDA. The 17 classification of medical devices are: 1) Ultrasound tumor therapy system(high-risk); 2) Diagnostic imaging device for the skin(high-risk); 3) Pressure distribution measurement cushion; 4) TCM sweating detector; 5) Medical image processing software; 6) Fluorescence imaging and graphic reporting software; 7) Ventilator heated expiratory filter; 8) Medical laser fiber; 9) Cochlear implant signal converter; 10) Device for measuring contrast sensitivity with glare; 11) Choledocho-fiberscope; 12) Ultrasound breast imaging diagnostic device; 13) Ophthalmic surgery observation device; 14) Efficient medical injection head processor; 15) One-stop flushing fluid processing system; 16) Medical air cleaner; 17) Mobile cart.
Q: What are the new measures which will implement in China to support the drug manufacturing industry?
A: According to a notice issued by four governmental authorities there are six measures which will implement to support the drug manufacturing industry, including: (i) encouraging M&A among drug manufacturers; (ii) strictly examining and approving the qualification of commissioned production enterprises; (iii) establishing a drug manufacture elimination mechanism; (iv) setting and adjusting drug prices by considering the interests of qualified GMP manufacturers; (v) introducing upgraded policies for drug bidding and tendering; and (vi) supporting qualified drug manufacturers in their efforts to construct preparation production lines that are aligned with international standards.
Q: What kind of challenge the sterile drug producer may face under the new Good Manufacturing Practices (GMPs)?
A: According to the notice issued by State Food and Drug Administration (SFDA) in 2011, all sterile drugs enterprises shall adapt the new GMP standards by the end of 2013. However, according to an official survey published in mid-December by SFDA that China has 4,462 production lines of sterile drugs in 1,319 enterprises, only 23 percent had planned to adapt to the new GMP standards by the end of 2012, and only 60 percent of them intend to do so by the end of 2013 For those sterile drug producers who fail to meet the deadline of qualify for the new GMP requirements for drugs may face relevant fine or other punishment.