Reed Smith Client Alerts

Pharmaceutical Devices, Health Care & Life Sciences


  • Beijing Hospital Requirements: Overuse of Antibiotics (Xinhua News Agency 2011-11- 10) - November 10, 2011
    The Beijing Health Bureau announced November 9 that the hospital grading appraisal will be initiated in 2012. All medical institutions to be appraised shall meet the following requirements: (i) the clinical use of antibiotics/antibacterial drugs shall meet the statutory standard; (ii) the promotion of hospital registration booking shall meet the relevant requirements; and (iii) nursing services in Beijing hospitals shall meet the working standard. A hospital failing to meet the requirements will be excluded from the appraisal and degraded.
  • SFDA Issues Second Batch of Class II Medical Devices, For Which Distributors Do Not Need to Apply for Medical Devices Distribution License (State Food and Drug Administration 2011-11-14) - November 14, 2011
    The State Food and Drug Administration (SFDA) listed the second batch of Class II medical devices based on input from the local SFDA offices for medical devices for which the distributor does not need to apply for a Medical Devices Distribution License. Medical devices in this second batch include electronic blood pressure and pulse instruments, Chinese plum blossom needles, three-edged needles, acupuncture needles, ovulation test strips and portable oxygen generators.
  • Interim Measures on Appraisal of Traditional Chinese Medicine Hospitals: Request for Comments (China Legal Information Center 2011-11-15) - November 15, 2011
    The Administrative Measures on Classification of Traditional Chinese Medicine Hospitals that have been implemented for 18 years will be replaced by the Interim Measures on Appraisal of Traditional Chinese Medicine Hospitals. Comments about the Interim Measures are sought from the industry. The third-class hospitals will be identified by the State Administration of Traditional Chinese Medicine after preliminary appraisal by the provincial counterparts. The second-class hospitals will be identified and appraised by the provincial traditional Chinese medicine administrations. And the provincial administration is entitled to formulate relevant regulations on appraisal of the first-class hospitals. All the hospitals will be graded into three levels including Level A, Level B and Unqualified. The unqualified hospitals will be issued rectification notices that will require them to improve operations within three to six months.
  • Two Pharmaceutical Companies Fined for Monopolizing Compound Reserpine API (National Development and Reform Commission 2011-11-14) - November 15, 2011
    Shuntong Medicine Co., Ltd. and Huaxin Medical Trading Co., Ltd. in Weifang, Shandong Province, were investigated and severely punished for illegal behaviors, including controlling compound reserpine API, bidding up prices, and obtaining exorbitant profits that cause relevant pharmaceutical companies to stop production. The compound reserpine API is an antihypertensive drug listed in the National Essential Drug List. China currently only has two enterprises to manufacture the API of compound reserpine. On June 9, 2011, Shuntong and Huaxin signed a sales agreement with the two manufacturers of compound reserpine API, respectively, monopolized the sales of API, and raised the price of API from 200 yuan/kg to 300-1350 yuan/kg. Several compound reserpine manufacturers were forced to stop production and rely on inventories to supply medical institutions. The National Development and Reform Commission investigated the two companies pursuant to the antitrust law, ordered them to stop illegal activities, and fined them RMB 6.877 million and RMB 152.6 thousand, respectively.
  • China to Build ADR Monitoring System (Xinhua News Agency 2011-11-17) - November 18, 2011
    China will develop a comprehensive nationwide system to monitor adverse drug reactions in five years, an official from the country's drug watchdog said Thursday. Adverse drug reactions (ADRs) refer to harmful and undesired effects that result from normal dosage of medicines, therapies or other kinds of interventions. Wu Zhen, deputy director general of the State Food and Drug Administration (SFDA), said at a national meeting on ADRs that China had already built a preliminary system to monitor ADRs at national, provincial and prefectural levels. 
  • NDRC to Investigate Ex-factory Prices of Drugs (Caijing 2011-11-23) - November 23, 2011
    The National Development and Reform Commission (NDRC) promulgated the Measures on Investigation of Ex-factory Prices of Drugs (for Trial Implementation). NDRC will initiate ex-factory price investigations on drugs subject to government pricing. Pharmaceutical manufacturers are required to truthfully fill in the Investigation Form of Basic Information of Manufactures and Drugs, and the Investigation Form of Drug Ex-factory Prices. The investigators shall select one to two pharmaceutical specifications to carry out the investigation. The investigation will cover ex-factory price and sales status. Ex-factory prices include the highest, the lowest and the average ex-factory prices. The current retail prices include the prices fixed by the state pricing authority, the provincial government of the place of origin, and the manufacturer, respectively. The sales status covers sales revenue, sales volume and the number of sales people. The pharmaceutical manufacturers will be subject to punishment on refusing to report, false reporting, improper reporting and refusing to cooperate in the investigation.
  • China Finalizes Healthcare Reform 12th FYP ( 2011-11-29) - November 30, 2011
    A member of National Healthcare Reform Expert Advisory Committee, Liu Guo'en, stated today that the Healthcare Reform 12th Five-Year Plan (FYP) has been finalized and submitted for review. The Plan focuses on optimizing the environment for the private sector to more easily enter into the hospital market, and aims to promote reform of public hospitals. The 12th FYP will also increase the supply of health care products and services by reforming the governance and management of hospitals, and will promote more supportive policies to attract the private sector into establishing additional private hospitals. 
  • China to Launch Massive Survey on TCM Resources (Xinhua News Agency 2011-11-06) - November 7, 2011 China will soon launch its fourth national survey on Traditional Chinese Medicine (TCM) resources to secure the industry's sustainable development, according to a senior health official. The preparatory work has been completed and a pilot program for the survey will commence soon, covering six provinces and regions, including Anhui, Hunan, Hubei, Sichuan, Xinjiang and Yunnan, said Wang Guoqiang, vice minister of health. Wang, also director of the State Administration of TCM, made the remarks Sunday at the annual gathering for the country's pharmaceutical professionals.


  • Notice Concerning Circulation of the 12th Five-year Plan of Biotechnology Development - November 30, 2011 The Ministry of Science and Technology (MOST) launched the Biotechnology Development 12th Five-Year Plan (FYP) November 28, with goals to facilitate the development of biomedicine, bio-agriculture, bio-manufacturing, bio-energy, and bio-environmental protection industries. The Plan identifies several areas pertaining to health and pharmaceuticals as priorities, including:
  • Development of new drugs and improvement of new drug systems, while modernizing technological tools for Chinese medicine
  • Research and development of new diagnostics and new vaccines for major contagious diseases, and the reduction of the contagion rate and mortality rate from diseases such as AIDS, viral hepatitis, and tuberculosis
  • Research and development of therapeutic vaccines and antibody-based drugs for major non-infectious diseases including cancer, cardiovascular and cerebrovascular diseases, metabolic diseases, and autoimmune diseases
  • Development of a number of innovative products with independent intellectual property rights
  • Breakthroughs in certain cutting-edge, high-end products for biomedical materials.