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  • China: Milestone Meeting Held Between Chinese, Taiwanese Regulators

    The first "cross-strait" Pharmaceuticals Inspection Technology seminar was jointly organized by the Chinese Food and Drug Testing and Research Institute, the Taiwanese Food and Drug Administration, and the Fujian Institute for Drug Control and held in Fuzhou, Fujian, on 6-7 June 2012. The seminar served to actively implement the bilateral "cross-strait medical and health cooperation agreement" signed by the Fujian Provincial People's Government and the State Food and ...
  • China: SFDA Issues New Draft Excipient Rules

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the...
  • China: New Draft Rules On Excipients

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June that would require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production.  The draft establishes drug manufacturers as having the primary responsibility to assure the quality of excipients obtained from suppliers The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and s...
  • China: SFDA Proposes Blacklisting Companies

    China's State Food and Drug Administration (SFDA) has issued a draft "blacklist" proposal that would be used for listing serious violators of laws and regulations. The 28 May list was sent to provinces and municipalities, and contains examples of the kind of violations that would support blacklisting a company. Examples provided include sales of counterfeit drugs, production and sale of inferior drugs, failure to obtain medical device registration certificate and de...
  • China: China Signs MOU with the Ukraine

    On 17 May 2012, Yin Li, commissioner of the Chinese State Food and Drug Administration's (SFDA), signed a bilateral Memorandum of Understanding ( MOU)  with the Deputy Director of the Ukrainian State Drug Administration, Andrei Zakharash.  The MOU will strengthen bilateral cooperation in regulatory matters, especially those relating to pharmaceuticals. Representatives from SFDA's International Cooperation Department and the head of SFDA's Drug Registration Depa...
  • China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds

    The Chinese State Food and Drug Administration (SFDA) issued a Notice to Provinces, Autonomous Regions, and Municipalities on 16 May revising the instructions in the Chinese non-prescription drugs (OTC) manual related to the pediatric use requirements for amantadine hydrochloride compounds.  The compounds can no longer be used in newborns and children under one year of age due to a lack of safety and effectiveness data and are not recommended for children under th...
  • China: Deadlines Established For Opthalmic GMP Implementation

    The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...
  • China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized

    Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters . Chromium is a heavy metal that has been associated with cancer in some circumstances. Chinese authorities originally announced on 15 April that they had found 13 pharmaceutical products-including antibiotics-to have b...
  • China: Device Testing and Globalization of Trade

    China must gradually establish an international device regulatory philosophy to adapt strategy to the globalization of trade, according to SFDA Commissioner Yin Li, who spoke at the medical device testing conference held in Zhuhai 10-11 April 2012. Li added that the medical device testing institutions are an important force in the medical device regulatory system, and have played a huge role in the development of China's device industry.  Attendees included: th...
  • China: Healthcare Reform Opportunity To Strengthen Regulation

    The National Bureau of Policy and Regulation Department's Liu Pei said on 12 April 2012 at a national food and drug regulation conference that health care reform provides an opportunity to strengthen the supervision and regulation of essential drugs. He also noted the importance of the global environment and its role in national food and drug policies and regulations. For 2012, the food and drug policies will include strengthening supervision over law enforcement an...
  • China Finds 13 Drugs Made With Excessive Levels of Chromium

    China's State Food and Drug Administration (SFDA) announced 15 April it had found 13 pharmaceutical products to have been manufactured with excessive levels of chromium and was suspending the sale of those products, reports The Wall Street Journal . The chromium was found to have emanated from drug-capsule manufacturers in the Zhejiang province in China, which were reported to be using industrial gelatin instead of gelatin marked for human consumption. The industrial-gr...
  • Joint FDA, Chinese Training Helping to Boost Product Safety

    The US Food and Drug Administration (FDA) announced it has trained more than 1,600 regulatory professionals in China on US safety standards, which It says is helping to develop an "infrastructure that better ensures product safety." In its 5 April website posting, FDA's China Offices Focus on Product Safety , FDA notes their 13-person staff in China "represents a new era in cooperation between the United States and China on the safety of food and medical products." "...