Volume VII 2011 CHINA PHARMACEUTICAL ڵNEWSLETTER З֡Ԛ哦֡ଢ଼рࡗЗ แྼჯ)ཀৄDž዆ᄱᆶ၌ࠅິ SFDA Commissioner Shao Mingli SFDA Deputy Commissioner Wu Zhen of NPC Standing Committee attended the met with new Cuban Ambassador to meets the Head of Iran's Innovation and meeting. Chen Zhu, the Health Minister China On September 29, 2011, Shao Technology Cooperation Center On the & Chairman of the Forum attended the Mingli, Commissioner of SFDA met morning of September 6, 2011, Wu Zhen, forum and delivered a speech. with Mr. ALberto Jesus Blanco Silva, the SFDA Deputy Commissioner, met with the Chen Zhu said in his speech, through new Cuban Ambassador Extraordinary visiting Mr. Hamidreza Amirinia, Head of 30 years of reform and opening up, and Plenipotentiary to China, and his Innovation and Technology Cooperation China's GDP has maintained a 10% entourage in Beijing. The two sides Center of Iran. Both parties exchanged growth in 30 consecutive years, and held in-depth discussions on further views on enhancing mutual exchanges and created an economic miracle. In 2010, strengthening the bilateral cooperation in understanding, and promoting cooperation China's GDP had ranked second in the WKH¿HOGVRIELRORJLFDl products and drug LQWKH¿HOGRIWUDGLWLRQDO&KLQHVHPHGLFLQH world. In the 21st century, the Chinese safety supervision. (September 30, 2011) and biopharmaceuticals. (September 8, 2011) Government pays more attention to social SFDA Deputy Commissioner Wu development, taking the alleviation of SFDA Deputy Commissioner Bian Zhen meets the delegation of MHLW On poverty and improvement of health care, Zhenjia attends the APEC LSIF Drug the morning of August 23, 2011, Wu Zhen, education, housing, and employment, etc. Safety and Detection Technology SFDA Deputy Commissioner, met with the as the priorities of public policy. Workshop The APEC Life Science visiting delegation headed by Dr. Yoshinobu Chen Zhu stressed that the "Twelfth Innovation Forum (LSIF) Drug Safety Hirayama, Councilor for Pharmaceutical and Five-Year Plan" Period is critical period and Detection Technology Workshop food safety Bureau of the Ministry of Health, for China’s healthcare reform and was held in Beijing on September Labor and Welfare of Japan (MHLW). Both development, in order to achieve the 27-28, 2011. Bian Zhenjia, Deputy parties discussed issues such as further health development goals within this Commissioner of SFDA was present strengthening and implementing exchanges Period; the Ministry of Health established at the opening ceremony and made a and cooperation under the framework of the following key tasks for healthcare speech. the Memorandum of Understanding, and reform: Themed on Drug Safety and Detection reached common understanding on relevant First, improve the health insurance Technologies, the workshop aims at: issues. The Japanese delegation visited the system.Second, taking the reform of sharing information on the appropriate Center for Drug Evaluation of SFDA in the county hospital as a breakthrough, deepen use of detection and prevention afternoon. (August 24, 2011) the reform of public hospitals. Third, technologies for drug safety and quality The Second China Health Forum Held establish and improve the drug supply by APEC economies; discussing the in Beijing On August 18, 2011, the Second guarantee system. Fourth, strengthen application of fast detection technologies, China Health Forum, jointly organized the construction of public health and improving capabilities of APEC by the Ministry of Health, SFDA, and the health service systems. Fifth, promote economies on cracking down counterfeit State Administration of Traditional Chinese the gradual equalization of basic public medicines; discussing the implementation Medicine (SATCM), was held in Beijing health services. Sixth, proactively of the APEC LSIF Anti-counterfeit National Convention Centre, the Forum took take advantage of the development of Medicines Action Plan and building the "Sustainable & Healthy Development traditional Chinese medicine. Seventh, international cooperation to ensure drug "as the theme to discuss healthcare reform accelerate the development of health safety. (September 14, 2011) and development. Han Qide, Vice Chairman industry. (August 25, 2011) Published by China Center for Pharmaceutical International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd. ࠶૙ਆ۽The SFDA Drug Safety Special Campaign Leading Group ࡔॆ๋೗ᄱ೗॔ ڞHeld Its Fourth Meeting ᄱ೗Ҿඇጆၜኝዎ߾ፕଶ ຺ْࣷᅱቻਸڼၭፇ On September 8, 2011, the SFDA Drug Office’s report on the implementation 2011౎9ሆ8නLjࡔॆ๋೗ᄱ೗॔࠶ਆ Safety Special Campaign Leading Group of the inspection & evaluation work ຺ڼၭፇቻਸڞᄱ೗Ҿඇጆၜኝዎ߾ፕଶ held its fourth meeting, Commissioner Shao plan set forth by Six Ministries and ْࣷᅱLjࡔॆ๋೗ᄱ೗॔࠶ਆਆ׊ต௽૬ Mingli of SFDA stressed at the meeting that Commissions to jointly carry out Drug ሞࣷᅱฉഽۙ ሾํፔࡻॠֱೠࠚ߾ፕ༵ื conscientious and concrete inspection & Safety Special Campaign, and the focuses ᄱ೗Ҿඇ຤ೝă evaluation works are called for to enhance of the forthcoming works. SFDA Deputy ࣷᅱჺ৯ඓۨକਸቛᄱ೗Ҿඇጆၜኝ the level of drug safety. Commissioner Bian Zhenjia summarized ዎॠֱೠࠚ߾ፕᆶ࠲๚ၜLjདൽକᄱ೗Ҿ and affirmed the achievements of Drug ඇጆၜኝዎӸࠅ๪࠲ᇀୃևਆ૴ࢇਸቛᄱ ࣹԒڦThe Meeting determined relevant issues to ೗Ҿඇጆၜኝዎॠֱೠࠚ߾ፕݛӄ Safety Special Campaign in the previous ߾ፕҾಇăࡔॆ๋೗ᄱ೗॔ۅcarry out the inspection & evaluation works ࢅူᅃօዘ VWDJHDQGVHWVSHFL¿FUHTXLUHPHQWVIRUWKH of Drug Safety Special Campaign, listened ࠶ਆՉናोޭਆ׊ጺ঳ࢅ੝ۨକᄱ೗Ҿඇ Special Campaign in the next stage. to the Drug Safety Special Campaign ጆၜኝዎമᅃ঩܎߾ፕLjܔူᅃօኝዎ߾ September 14, 2011) ፕ༵؜କ௽ඓᄲ൱ă DŽ2011౎9ሆ14නDž) ࠶૙ਆ۽SFDA Issued the Public Announcement on GMP ࡔॆ๋೗ᄱ೗॔ &HUWLÀFDWLRQ ݀քᄱ೗GMPණኤࠅߢ On September 13, 2011, SFDA issued the tai Tianqing Pharmaceutical Co., Ltd., 2011౎9ሆ13නLjࡔॆ๋೗ᄱ೗॔࠶ਆ 231ࡽDžLjڼ3XEOLF$QQRXQFHPHQWRQ*03&HUWL¿FDWLRQ Jiangsu Hengrui Medicine Co., Ltd., ݀քକᄱ೗GMPණኤࠅߢDŽ ࠶૙ਆĖᄱ೗ิׂ۽No. 231). In accordance with the Qilu Pharmaceutical Co., Ltd., Wuhan Ӏቷࡔॆ๋೗ᄱ೗॔) ࡀۨLjঢ়ڦrequirements of SFDA’s “Measures for Drug Institute of Biological Products, Beijing ዊଉ࠶૙ࡀݔණኤ࠶૙Ӹ݆ė ཀ൥ᄱᄽٷGMP Certification”, eight pharmaceutical Tide Pharmaceutical Co., Ltd., Shanghai ၄ׇॠֱࢅอࢃ಼ጚLjॿ໋ኟ ࢇĖᄱޙ8ॆᄱ೗ิׂഓᄽڪmanufacturers including Jiangsu Chia-tai Celgen Bio-Pharmaceutical Co., Ltd., ࠣݻᆶ၌ࠅິ Tianqing Pharmaceutical Co., Ltd., which Nanchang Lijian Pharmaceutical Co., Ltd., ೗ิׂዊଉ࠶૙ࡀݔDŽ2010౎Ⴊ۩Džėᄲ comply with the Good Manufacturing and Guangdong Xing Hao Pharmaceutical ൱Lj݀ߴĖᄱ೗GMPኤກėă 8ॆഓڦPractice for Drugs (2010 Revised Edition), Co., Ltd. (September 13, 2011) ๯಼ཚࡗႎႪ۩ᄱ೗GMPණኤ ཀ൥ᄱᄽࠣݻᆶ၌ࠅິĂٷKDYHREWDLQHGWKH³'UXJ*03&HUWL¿FDWLRQ´ ᄽ๟ǖॿ໋ኟ after on-site inspection, verification and ॿ໋࢛෌ᅅᄱࠣݻᆶ၌ࠅິĂഋ୛዆ᄱᆶ ڤapproval. ၌ࠅິĂ࿴ࡲิ࿿዆೗ჺ৯໯Ăԛ৙໽ The eight manufacturers in the first ዆ᄱࠣݻᆶ၌ࠅິĂฉ࡛ෘূิ࿿ᅅᄱᆶ batch that passed the newly revised ၌ࠅິĂళׅ૬ॳᄱᄽᆶ၌ࠅິĂ࠽۫႓ GMP Certification are: Jiangsu Chia- ᨓᄱᄽᆶ၌ࠅິă DŽ2011౎9ሆ13නDž ۆٷ7KH5HYLVLRQRIWKH6WDQGDUG&ODVVLÀFDWLRQRI2FFXSDWLRQVLQ ࿢ࡔᅅᄱႜᄽኰᄽݴૌ ۯChina's Pharmaceutical Industry Comprehensively Initiated Ⴊ۩߾ፕඇ௬ഔ ࠶۽On September 6, 2011, the SFDA Work medical devices related occupations)", 2011౎9ሆ6නLjࡔॆ๋೗ᄱ೗॔ Ⴊ۩߾ፕࣷᅱሞࡔॆ๋ۆٷMeeting on the Revision of the Standard and deployed the specific research on ૙ਆኰᄽݴૌ ࠶૙ਆߛपჺႪბᇾਉႜăࣷ۽Classification of Occupations in China’s the description of occupations. The ೗ᄱ೗॔ ĕۆٷpharmaceuticals industry was held in convening of the meeting marked the ᅱჺ৯ඓۨକĖĔࡔॆኰᄽݴૌ at the SFDA Institute of Executive overall launch of the revision of Standard DŽᄱ೗ᅅଐഗႁ၎࠲ኰᄽDžႪ۩߾ፕํแ ኰᄽ௮ຎ႑တਏ༹ۙჺ߾ፕ৊ܔDevelopment. The meeting studied and Classification of Occupations related to ݛӄėLj ቻਸՔኾጣᄱ೗Ăᅅଐڦformulated the "Implementation Program drugs and medical devices. ႜକևຈăࣷᅱ ăۯഗႁ၎࠲ኰᄽႪ۩߾ፕᅙඇ௬ഔ for the Revision of National Standard (September 8, 2011) DŽ2011౎9ሆ8නDž Classification of Occupations (drugs & 2 CHINA PHARMACEUTICAL NEWSLETTER ඇ௬ۯNational Safe Medication Month" Campaign Launched in ĐඇࡔҾඇᆩᄱሆđऄ" ۯ2YHUDOO6FDOH ഔ On September 1, 2011, the "National Safe Popularization (2011-2015)" formulated 2011౎9ሆ1නLjĐඇࡔҾඇᆩᄱሆđ Medication Month" campaign was launched and promulgated by SFDA, In the "Twelfth Ljৃ౎ĐඇࡔҾඇᆩᄱሆđۯඇ௬ഔۯऄ ዷ༶๟Đ৉ݞྪஏ೻ቋၨ๳्ᄱđă߳ڦ in an all-round way, the theme of this year's Five-Year Plan" Period, the "National activity is "Beware of Online Fraud Selling Safe Medication Month" activities shall be प๋೗ᄱ೗॔࠶ևோॽ৆৆ྷජኄᅃዷ༶ ऄدҾඇᆩᄱ੔೵Ⴧڦዖႚ๕ܠCounterfeit Drugs". Centering on this theme, held in September each year. Under the णዐਸቛ ࠅዚĐҾඇᆩᄱ ॳ੃ิऄđăฉڞבLjۯ the food and drug administration departments action plan, SFDA will also organize on a Ljࡔॆ๋೗ᄱ೗॔࠶ਆᅜतู߳Ăۅat all levels will carry out a variety of science nationwide scale the "Food and Drug Safety ࿷ๆ ഔۯpromotion activities on safe medication to Knowledge Forum", "Public Service of ๨Ă၆๋೗ᄱ೗॔࠶ਆཞ้ਉႜକऄ ᅏ๕Ljࡔॆ๋೗ᄱ೗॔࠶ਆޭਆ׊૚ीۯ lead the public to use medicines safely and Video Broadcasts on Food and Drug Safety ժ঄ࣆăۯᅏ๕ዷׇࣷऄۯlive a healthy life. At 10: 00AM, SFDA Knowledge " and outdoor publicity activities ೝ؜ဝഔ ݀۩ߵ਍ࡔॆ๋೗ᄱ೗॔࠶ਆ዆ and the food and drug administrations in all for public interest. (September 1, 2011) ऺࣄۯĖඇࡔ๋೗ᄱ೗Ҿඇ੔೵ႜڦք provinces, cities and counties held the launch DŽ2011ċ2015DžėLjĐๆܾ࿵đ้೺Lj௅౎9 ceremony; SFDA Deputy Commissioner Li ăۯॽፇኯਸቛĐඇࡔҾඇᆩᄱሆđऄۼሆ Jiping attended the Ceremony at the main ऺࣄLjࡔॆ๋೗ᄱ೗॔࠶ਆ࣏ॽۯӀቷ޿ႜ venue and delivered a speech. ፇኯሞඇࡔݔྷాਸቛĐ๋೗ᄱ೗Ҿඇኪ๎ խݣđೌد঄༗đĂĐ๋೗ᄱ೗ҾඇࠅᅮჇٷ According to the "National Action ă DŽ2011౎9ሆ1නDžۯऄڪدPlan for Food and Drug Safety Science ࢅࢽྔࠅᅮჇ ࠶૙ਆ۽State Food and Drug Administration mandated the ࡔॆ๋೗ᄱ೗॔ cessation of the production, sales and application of ਦۨཕኹิׂၨ๳ࢅ๑ᆩ clenobuterol hydrochloride tablets ჸ໗ਖ਼஀༬ஆೌव ࠶۽On September