Reed Smith Client Alert

Authors: Jay J. Yan Katherine Yang Mao Rong May Ling Wong

Pharmaceuticals, Medical Devices, Health Care & Life Sciences

News & Regulations 

  • Industry Calls for Reform of Lagging Drug Review System (Global Times 2012-12-02) – December 3, 2012

A reform of China's drug review system is necessary in order to hasten pharmaceutical innovation, industry experts advised during a forum held in Beijing in early December. A report recently released by the Research and Development Pharmaceutical Association Committee (RDPAC), an organization that represents 37 leading pharmaceutical companies in China, indicates that access to innovative drugs in China generally lags four to eight years behind that in other countries. This is based, in part, on the protracted review process in China, as well as the limited capacity of the reviewing body.

  • Four Governmental Authorities to Take Measures to Upgrade Good Manufacturing Practices (GMPs) (Economic Information Daily 2012-12-04) – December 4, 2012

Four governmental authorities, including the State Food and Drug Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health, will jointly issue a Notice Concerning Accelerating the Implementation of New GMP Requirements and Upgrading the Pharmaceutical Industry. This notice will require drug manufacturers to fulfill the new Good Manufacturing Practices (GMP) requirements by the end of 2016. China will implement six measures that are aimed at supporting 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.

  • Chinese Manufacturers of Sterile Drugs Struggling to Meet New GMP Deadline (Xinhua News Agency 2012-12-14) – December 14, 2012

About 17 percent of China's sterile drug producers may fail to meet a deadline to qualify for China’s new Good Manufacturing Practices (GMP) requirements for drugs, according to an official survey published in mid-December. The survey, conducted by the State Food and Drug Administration, indicates that although 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, which is the legal deadline.

  • Pharmaceutical Market to Hit 2.3 trillion Yuan by '20 (Xinhua News Agency 2012-12-31) – December 31, 2012

China's pharmaceutical market is expected to soar to 2.3 trillion yuan ($369.2 billion) by 2020, up from 926.1 billion yuan in 2012, according to a report published by the Social Sciences Academic Press. The Report on China's Pharmaceutical Market 2012 observes that China’s aging population will likely increase demand for medicine, while the fast-growing economy is expected to boost both social insurance levels and consumption capacities. According to the report, these factors will help China's pharmaceutical market expand at an average annual rate of 12 percent by 2020.

  • China Announces 17 New Device Classifications (RF Regulatory Focus 2012-12-21) – December 31, 2012

On December 10, 2012, China’s State Food and Drug Administration (SFDA) issued a notice to the provinces and autonomous regions announcing the classification of 17 medical devices. These classifications were derived from expert advice provided to the SFDA. Among the newly classified devices, two of the products will be regulated as Class III (high-risk) medical devices: an ultrasound tumor therapy system and a diagnostic imaging device for the skin.

  • Hong Kong, Macao Health Providers Allowed to Set Up Mainland Health Institutions (Xinhua News Agency 2012-12-08) – December 10, 2012

The Ministry of Health recently announced that Hong Kong and Macao health service providers may establish health institutions in mainland China beginning January 2013. Providers may set up health institutions that are wholly owned, jointly invested, or part of cooperative partnerships with other health establishments or enterprises in mainland China. 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, which will, according to the MOH, result in simpler procedures.

  • Smaller Hospitals "Offer Huge Opportunities" (China Daily 2012-12-13) – December 13, 2012

A recent study reports that China's county-level hospitals and community health care centers "offer huge opportunities" for multinational and local pharmaceutical companies. The study, which was conducted by global management and business strategy advisory firm Boston Consulting Group, was based on more than 60 in-person interviews and 900 detailed surveys provided by hospital heads, physicians and patients. According to the report, China's 10,000 county-level hospitals, with their huge patient population base and potential for rapid growth, hold the greatest opportunities for pharmaceutical companies.

  • White Paper on Medical and Health Services in China (China Daily 2012-12-27) – December 27, 2012

For the first time, the State Council Information Office of the People's Republic of China published a white paper on medical and health services in China. The white paper, which is divided into nine parts, reports that China’s total expenditures for health care in 2011 reached approximately RMB 2.4 trillion (US$390 billion), accounting for about 5.1 percent of China’s GDP. The white paper also observes that in China, the average life expectancy has reached 74.8 years. The white paper acknowledges the contributions of the latest round of health care reform in China, as well as other improvements enacted within the health care sector. These include an overview of health care reform; infectious disease prevention and treatment; prevention and treatment of chronic, non-communicable disorders; health emergency management; protecting women's and children’s health. And traditional Chinese medicine.

  • Reed Smith’s China Device Regulatory Briefing – December 4, 2012 – Practical Tips

On December 4, 2012, Reed Smith held a regulatory briefing on China’s regulation of medical devices. Speakers included officials from the Shanghai Municipal Food and Drug Administration, as well as from the United States Food and Drug Administration’s office in Beijing. The briefing informed the attendees about medical device development and registration requirements at both the regional and national levels. Attached is a summary of priorities, practical tips, and lessons learned from the briefing. (Please note that this summary was also included in last month’s briefing, and is reprinted here.)


Client Alert 2013-012