Volume VII 2011 CHINA PHARMACEUTICAL ڵNEWSLETTER З֡Ԛ哦֡ଢ଼рࡗЗ แྼჯ)ཀৄDžᄱᆶ၌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 ࡔॆ๋ᄱ॔ ڞHeld Its Fourth Meeting ᄱҾඇጆၜኝዎ߾ፕଶ ຺ْࣷᅱቻਸڼၭፇ On September 8, 2011, the SFDA Drug Office’s report on the implementation 20119ሆ8නLjࡔॆ๋ᄱ॔࠶ਆ Safety Special Campaign Leading Group of the inspection & evaluation work ຺ڼၭፇቻਸڞᄱҾඇጆၜኝዎ߾ፕଶ held its fourth meeting, Commissioner Shao plan set forth by Six Ministries and ْࣷᅱLjࡔॆ๋ᄱ॔࠶ਆਆต૬ 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 ᄱҾඇೝă evaluation works are called for to enhance of the forthcoming works. SFDA Deputy ࣷᅱჺ৯ඓۨକਸቛᄱҾඇጆၜኝ the level of drug safety. Commissioner Bian Zhenjia summarized ዎॠֱೠࠚ߾ፕᆶ࠲๚ၜLjདൽକᄱҾ and affirmed the achievements of Drug ඇጆၜኝዎӸࠅ࠲ᇀୃևਆࢇਸቛᄱ ࣹԒڦThe Meeting determined relevant issues to Ҿඇጆၜኝዎॠֱೠࠚ߾ፕݛӄ Safety Special Campaign in the previous ߾ፕҾಇăࡔॆ๋ᄱ॔ۅcarry out the inspection & evaluation works ࢅူᅃօዘ VWDJHDQGVHWVSHFL¿FUHTXLUHPHQWVIRUWKH of Drug Safety Special Campaign, listened ࠶ਆՉናोޭਆጺࢅۨକᄱҾඇ Special Campaign in the next stage. to the Drug Safety Special Campaign ጆၜኝዎമᅃ߾ፕLjܔူᅃօኝዎ߾ September 14, 2011) ፕ༵କඓᄲ൱ă DŽ20119ሆ14නDž)
࠶ਆ۽SFDA Issued the Public Announcement on GMP ࡔॆ๋ᄱ॔ &HUWLÀFDWLRQ ݀քᄱGMPණኤࠅߢ
On September 13, 2011, SFDA issued the tai Tianqing Pharmaceutical Co., Ltd., 20119ሆ13නLjࡔॆ๋ᄱ॔࠶ਆ 231ࡽDžLjڼ3XEOLF$QQRXQFHPHQWRQ*03&HUWL¿FDWLRQ Jiangsu Hengrui Medicine Co., Ltd., ݀քକᄱGMPණኤࠅߢDŽ ࠶ਆĖᄱิׂ۽No. 231). In accordance with the Qilu Pharmaceutical Co., Ltd., Wuhan Ӏቷࡔॆ๋ᄱ॔) ࡀۨLjঢ়ڦrequirements of SFDA’s “Measures for Drug Institute of Biological Products, Beijing ዊଉ࠶ࡀݔණኤ࠶Ӹ݆ė ཀᄱᄽٷGMP Certification”, eight pharmaceutical Tide Pharmaceutical Co., Ltd., Shanghai ၄ׇॠֱࢅอࢃ಼ጚLjॿ໋ኟ ࢇĖᄱޙ8ॆᄱิׂഓᄽڪmanufacturers including Jiangsu Chia-tai Celgen Bio-Pharmaceutical Co., Ltd., ࠣݻᆶ၌ࠅິ Tianqing Pharmaceutical Co., Ltd., which Nanchang Lijian Pharmaceutical Co., Ltd., ิׂዊଉ࠶ࡀݔDŽ2010Ⴊ۩Džėᄲ comply with the Good Manufacturing and Guangdong Xing Hao Pharmaceutical ൱Lj݀ߴĖᄱGMPኤກėă 8ॆഓڦPractice for Drugs (2010 Revised Edition), Co., Ltd. (September 13, 2011) ಼ཚࡗႎႪ۩ᄱGMPණኤ ཀᄱᄽࠣݻᆶ၌ࠅິĂٷKDYHREWDLQHGWKH³'UXJ*03&HUWL¿FDWLRQ´ ᄽǖॿ໋ኟ after on-site inspection, verification and ॿ໋࢛ᅅᄱࠣݻᆶ၌ࠅິĂഋᄱᆶ ڤapproval. ၌ࠅິĂࡲิჺ৯Ăԛ The eight manufacturers in the first ᄱࠣݻᆶ၌ࠅິĂฉ࡛ෘূิᅅᄱᆶ batch that passed the newly revised ၌ࠅິĂళׅ૬ॳᄱᄽᆶ၌ࠅິĂ࠽۫႓ GMP Certification are: Jiangsu Chia- ᨓᄱᄽᆶ၌ࠅິă DŽ20119ሆ13නDž
ۆٷ7KH5HYLVLRQRIWKH6WDQGDUG&ODVVLÀFDWLRQRI2FFXSDWLRQVLQ ࡔᅅᄱႜᄽኰᄽݴૌ ۯChina's Pharmaceutical Industry Comprehensively Initiated Ⴊ۩߾ፕඇ௬ഔ
࠶۽On September 6, 2011, the SFDA Work medical devices related occupations)", 20119ሆ6නLjࡔॆ๋ᄱ॔ 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 ᄱ॔ 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 DŽᄱᅅଐഗႁ၎࠲ኰᄽDžႪ۩߾ፕํแ ኰᄽ௮ຎ႑တਏ༹ۙჺ߾ፕܔDevelopment. The meeting studied and Classification of Occupations related to ݛӄėLj ቻਸՔኾጣᄱĂᅅଐڦformulated the "Implementation Program drugs and medical devices. ႜକևຈăࣷᅱ ăۯഗႁ၎࠲ኰᄽႪ۩߾ፕᅙඇ௬ഔ for the Revision of National Standard (September 8, 2011) DŽ20119ሆ8නDž 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 20119ሆ1නLjĐඇࡔҾඇᆩᄱሆđ Medication Month" campaign was launched and promulgated by SFDA, In the "Twelfth LjৃĐඇࡔҾඇᆩᄱሆđۯඇ௬ഔۯऄ ዷ༶Đݞྪஏቋၨ्ᄱđă߳ڦ 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 प๋ᄱ॔࠶ևோॽྷජኄᅃዷ༶ ऄدҾඇᆩᄱჇڦዖႚ๕ܠCounterfeit Drugs". Centering on this theme, held in September each year. Under the णዐਸቛ ࠅዚĐҾඇᆩᄱ ॳิऄđăฉڞבLjۯ the food and drug administration departments action plan, SFDA will also organize on a Ljࡔॆ๋ᄱ॔࠶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 Ă၆๋ᄱ॔࠶ਆཞ้ਉႜକऄ ᅏ๕Ljࡔॆ๋ᄱ॔࠶ਆޭਆीۯ lead the public to use medicines safely and Video Broadcasts on Food and Drug Safety ժࣆăۯᅏ๕ዷׇࣷऄۯlive a healthy life. At 10: 00AM, SFDA Knowledge " and outdoor publicity activities ೝဝഔ ݀۩ߵࡔॆ๋ᄱ॔࠶ਆ and the food and drug administrations in all for public interest. (September 1, 2011) ऺࣄۯĖඇࡔ๋ᄱҾඇႜڦք provinces, cities and counties held the launch DŽ2011ċ2015DžėLjĐๆܾđ้Lj9 ceremony; SFDA Deputy Commissioner Li ăۯॽፇኯਸቛĐඇࡔҾඇᆩᄱሆđऄۼሆ Jiping attended the Ceremony at the main ऺࣄLjࡔॆ๋ᄱ॔࠶ਆ࣏ॽۯӀቷႜ venue and delivered a speech. ፇኯሞඇࡔݔྷాਸቛĐ๋ᄱҾඇኪ๎ խݣđೌد༗đĂĐ๋ᄱҾඇࠅᅮჇٷ According to the "National Action ă DŽ20119ሆ1නDžۯऄڪدPlan for Food and Drug Safety Science ࢅࢽྔࠅᅮჇ
࠶ਆ۽State Food and Drug Administration mandated the ࡔॆ๋ᄱ॔ cessation of the production, sales and application of ਦۨཕኹิׂၨࢅ๑ᆩ clenobuterol hydrochloride tablets ჸ໗ਖ਼༬ஆೌव
࠶۽On September 23, 2011, the State Food of its application in China outweighs its 20119ሆ23නLjࡔॆ๋ᄱ॔ and Drug Administration issued a notice on EHQH¿WV ਆ݀ཚኪLjཕኹჸ໗ਖ਼༬ஆೌवሞ the cessation of the production, sales and ၨ಼ጚኤםĂၨࢅ๑ᆩLjׂิڦAccording to relevant provisions in the Drug ࡔ application of clenobuterol hydrochloride ࿔ॲă Administration Law of China, the State ࠶۽tablets, by way of revocation of its approval ጲ2009๔Ljࡔॆ๋ᄱ॔ Food and Drug Administration mandated DQGFHUWL¿FDWLRQGRFXPHQWV ਆፇኯܔჸ໗ਖ਼༬ஆਸቛକምೠॏă the cessation of the production, sales and ჸܔࡔాྔփଆݒᆌ൧ႜॠLjܔঢ় Since 2009, the State Food and Drug application of clenobuterol hydrochloride ໗ਖ਼༬ஆิׂĂঢ়ᆐ൧ᅜतሞ߳पᅅ Administration has organized and tablets via revocation of its approval ଐऐࠓ๑ᆩ൧ႜֱۙLjժ࠽ݘኙ൱ᅅ implemented a Re-evaluation upon ၎࠲ଶᇘጆॆᅪ९Ljምೠॏᅪڪand certification documents; the drugs ბĂᄱბ clenobuterol hydrochloride. Upon the already produced shall be destroyed under ९ණྺჸ໗ਖ਼༬ஆೌवਏᆶയሞરᆩޅ ॏኵᆶ၌Ljփࢇ๑ᆩضliterature review of its adverse reactions at the supervision of local Food and Drug ၃Ljଣ ࣒ኁ႐ݬࠀీׂิჹዘᆖၚLjሞࡔ๑ܔ .home and abroad, the investigations of the Administration departments ᇀၳᅮăٷ၃ޅproduction, sales and application in medical ᆩ The other dosage forms of clenobuterol institutions at all levels, and the opinions ߵĖᄱ࠶݆ė၎࠲ࡀۨLjࡔॆ hydrochloride such as aerosol, micropowders ࠶ਆਦۨཕኹჸ໗ਖ਼༬۽broadly solicited from experts in medicine, ๋ᄱ॔ and compound preparations are subjected to ၨםĂၨࢅ๑ᆩLjׂิڦpharmacy and other related fields, the Re- ஆೌवሞࡔ the management of Prescription Drugs, their ๋ںړᄱᆯڦevaluation has concluded that clenobuterol ಼ጚኤ࿔ॲǗᅙิׂ appropriate application under the guidance ၨ࣯ă۽࠶ևோ॔۽hydrochloride tablets have potential risks ᄱ॔ of doctors is safe, and their potential risks of ჸ໗ਖ਼༬ஆഄव႙ᆶഘवĂݹ and limited clinical value, its long-term ݛᄱ࠶LjሞᅅتLjӀቷڪdrug abuse are comparatively low, therefore वᅜतްݛव and inappropriate application may impose ၃ޅLjയሞરᆩڦࢇ๑ᆩҾඇူڞthese dosage forms are to be retained. ิኸ serious impact on the cardio-pulmonary Ljᅺُᇎᅜԍାă DŽ20119ሆ29නDžگড function of the patients, therefore the risk (September 29, 2011)
Volume VII 2011 3 ࠶ਆ۽$5HOHDVH$OHUWRQWKH6HYHUH+HSDWRWR[LFLW\RI2UDO ࡔॆ๋ᄱ॔'(6 ڦवޜKetoconazole Preparations ༵ႝয়༼ཛྷᙀ੨ Ⴀ۾ჹዘߊ Recently, the National Center for peripheral nervous system, hepatobiliary නമLjࡔॆᄱփଆݒᆌ֪॔ዐ႐݀ք Adverse Drug Reaction Monitoring system, and systemic damage. In view 40Ėᄱփଆݒᆌ႑တཚԒėLj༵ႝڼକ issued the 40th "Adverse Drug Reaction of the severe hepatotoxicity of oral ᅅခ߾ፕኁĂᄱิׂঢ়ᆐഓᄽᅜतࠅዚয় Information Bulletin" to remind ketoconazole preparations, SFDA Ⴀ࿚༶ă۾ჹዘߊڦवޜཛྷᙀ੨༼ healthcare professionals, pharmaceutical recommends healthcare workers and 20041ሆ1න20117ሆ12නLjࡔॆ manufacturers, distributors and the public patients to choose this drug only when ᄱփଆݒᆌ֪॔ዐ႐թ૩Ԓߢຕੰዐ to be wary of the severe hepatotoxicity of other antifungal therapy fails, and the ᆶཛྷᙀ੨ޜवթ૩Ԓߢࠌऺ1621૩Lj oral ketoconazole preparations. benefits of its application outweigh its փଆݒᆌ/๚ॲዷᄲྺ࿈ဣཥ࡞Ăೄ risks; SFDA suggests patients to perform From January 1, 2004 to July 12, 2011, the ޒतഄॲ࡞Ăዐतྔዜหঢ়ဣཥ liver function tests prior to treatment, and Ǘഄዐڪဣཥ࡞ĂඇวႠ࡞ڊcase-report database of the National Center ࡞Ăߊ perform regular checkups during treatment, for Adverse Drug Reaction Monitoring has ჹዘթ૩116૩LjᆶԒߢ7.16%Ljഄዐ so as to monitor the signs and symptoms reported a total of 1621 ADR cases of oral ຶྨթ૩2૩ă116૩ჹዘփଆݒᆌԒߢภ ڦႠ۾ketoconazole preparations, the adverse potentially elicited by hepatotoxicity, and तփଆݒᆌ၄157૩ْLjഄዐᆶߊ reactions / events are mainly manifested reduce the incidence of serious adverse ၄ྺ92૩ْLjᆶჹዘփଆݒᆌ၄ (August 31, 2011) Ljዷᄲփଆݒᆌ၄ྺߊࠀీᅴ%58.60ڦ .in damages to the gastrointestinal system, reactions ăڪ۾skin and its accessories, central and ĂߊฅĂߊᄁĂߊዐ ۾ߊڦव٪ሞჹዘޜ६ᇀཛྷᙀ੨ ࠶ਆॺᅱᅅࢺටᇵ۽ႠLjࡔॆ๋ᄱ॔ ࢅ࣒ኁሞስᆩᄱ้Ljኻᆶഄੇኈਪᄱ ၃้Lj֍ޅᇀٷၳᅮڦዎଐၳLj๑ᆩ ୯๑ᆩԨǗॺᅱ࣒ኁዎଐമᆌံႜߊࠀ ॠֱLjሞዎଐक़ᆌۨႜॠֱLj॔ీ ኙࢅኢጒLjᅜ३ณ༹ڦႠᆅ݀۾ీᆯߊ֪ ă DŽ20118ሆ31නDžิ݀ڦჹዘփଆݒᆌ
࠶ਆ۽SFDA Released the Notice on Converting 48 Kinds of ࡔॆ๋ᄱ॔ 48ዖᄱڪUXJV6XFK$V:RXQG2LQWPHQWWR1RQ3UHVFULSWLRQ'UXJV ݀քዎฅߜ' ཚኪڦݛᄱتገ࣑ྺݥ According to the "Classified Management in light of the "Notice on the Issuance of ݛᄱݴૌ࠶ӸتݛᄱᇑݥتߵĖ Measures for Prescription Drugs and Non- Specification Details of the Instructions of 10ڼ࠶ਆସ۽ႜ)ėDŽࡔॆᄱ॔)݆ Prescription Drugs (Trial)" (State Drug Non-Prescription Drugs" (SFDA Department ࡽDžࡀۨLjঢ়ࡔॆ๋ᄱ࠶ਆอۨLj Administration Order No. 10), and with the of Drug Registration [2006] No. 540) and the 48ዖᄱDŽࣅბᄱ8ዖĂዐڪዎฅߜ approval of SFDA, 48 kinds of drugs such as relevant SFDA regulations. (August 16, 2011) ݛᄱă20118ሆ2تׯᄱ40ዖDžገ࣑ྺݥ Wound ointment (8 chemicals and 40 Chinese 48ڦනLjࡔॆ๋ᄱ࠶ਆ݀քକገ࣑ patent medicines) were converted into non- ݛᄱຫກݔԨăጲتतഄݥڇዖᄱఁ prescription drugs. On August 2, 2011, SFDA ݛتքኮනഐLjनӀቷĖ࠲ᇀᆇ݀ݥ݀ released the list of 48 converted drugs and ཚኪėDŽࡔ๋ᄱ॔ጀڦᄱຫກࡀݔဦሶ the format of the instruction for these non- ࠶۽Ē2006ē540ࡽDžࢅࡔॆ๋ᄱ॔ prescription drugs. Since the release date, ਆᆶ࠲ࡀۨLjႜᅜฉዖຫກࢅՔധ the instructions & labels alteration work Վ߸߾ፕă DŽ20118ሆ16නDžڦ for the above varieties can be carried out
4 CHINA PHARMACEUTICAL NEWSLETTER Notice on the Issuance of the New Version of GMP ࠲ᇀഔᆩႎӲԨᄱGMP ཚኪڦHUWLÀFDWHV ኤກ& For the successful implementation of Good Second, the new version of the "Drug GMP ፔࡻĖᄱิׂዊଉ࠶ࡀݔྺ Manufacturing Practice for Drugs (2010 Certificate" is light blue in paper, while DŽ2010Ⴊ۩DžėDŽᄱGMPDžํแ߾ Revised Edition) (Drug GMP), SFDA revised the content, format are identical with the ࠶ਆႪ۩କĖᄱ۽ፕLjࡔॆ๋ᄱ॔ the pattern of "Drug GMP Certificate" and original version. GMPኤກėᄣ๕Ljժᇀ20118ሆ20න݀ issued the notice on August 20, 2011. Third, all provincial food and drug քକഔᆩཚኪă The new Certificates shall be officially in administration departments should ĖᄱGMPኤກėᄣ๕ጲཚኪ݀քኮ use as of the release date of this Notice. strengthen the management of "Drug GMP නഐኟ๕ഔᆩăᆶ࠲๚ၜཚኪසူǖ ࠶ևோᆌ۽The information on relevant matters is as Certificates", conscientiously and orderly ᅃĂู߳प๋ᄱ॔ แĔᄱิׂዊଉ࠶ࡀํןӀቷĖ࠲ᇀ࠻ follows: performing the coding, registration, and ཚኪėDŽࡔ๋ᄱ॔ҾڦݔDŽ2010Ⴊ۩Džĕ issuance of the Certificates, to ensure the ཚࡗႎႪ۩ᄱܔFirst, all provincial food and drug Ē2011ē101ࡽDžᄲ൱Lj smooth transition. व႙DŽׂDžLjႜՊࡽڦadministration departments should follow GMPॠֱණኤ ӀܔĖᄱGMPኤກėăڦthe requirements of the "Notice on the All provincial food and drug administration ժ݀ݣႎӲԨ Implementation of Good Manufacturing departments can, in light of the actual work ቷࡀۨᇀ20113ሆ1නമᅙժӀቷĖᄱ Practice for Drugs (2010 Revised Edition) VLWXDWLRQRIGUXJFHUWL¿FDWLRQDQGLQVSHFWLRQ ิׂዊଉ࠶ࡀݔDŽ1998Ⴊ۩DžėՔጚ व႙DŽׂDžLjሞཚࡗණኤࢫ݀ڦSFDA Department of Drug Safety & in their respective administrative area, ॠֱණኤ) " Inspection [2011] No. 101), re-code and contact the SFDA Administrative Service ݣᇱӲԨĖᄱGMPኤກėă GMP issue new versions of the "Drug GMP Center and receive the new version of the ܾĂႎӲԨĖᄱ ኤກėჿྺ ઢLjాඹĂ߭๕ᇑᇱӲԨĖᄱGMPڏ Certificates" to formulations (products) that 'UXJ*03&HUWL¿FDWH (August 24, 2011) ኤກė၎ཞă SDVVHGWKHLQVSHFWLRQDQGFHUWL¿FDWLRQRIWKH ࠶ևோᄲ۽ෙĂู߳प๋ᄱ॔ newly revised Drug GMP. While the original ࠶LjණኈፔڦഽĖᄱGMPኤກėे YHUVLRQRI'UXJ*03&HUWL¿FDWHVVKDOOVWLOO ᆶႾĂփڟऻĂ݀ݣ߾ፕLjፔکࡻՊࡽĂ be issued to formulations (products) that have Ljೝ࿘ࡗ܉ă ࠶ևோߵ۽been accepted for & passed the inspection ൩ู߳प๋ᄱ॔ DQGFHUWL¿FDWLRQLQDFFRUGDQFHZLWKWKH*RRG ႜአ൶ᇘాᄱණኤॠֱ߾ፕํाLjᇑࡔ Manufacturing Practice for Drugs (1998 ॆਆႜአޜခዐ႐ဣժଶൽႎӲԨ Revised Edition) before March 1, 2011. ĖᄱGMPኤກėă DŽ20118ሆ24නDž
࠶ਆ۽Answers from the Center for Drug ࡔॆ๋ᄱ॔ & Q A Evaluation of SFDA for submitting ᄱอೠዐ႐࠲ᇀ༵CTD ٴڦdossiers in CTD format ߭๕ጨଙᆶ࠲࿚༶ ٴ࿚ᇑ
(To continue) A: Actually, establishment of analytical DŽথฉDž XVI. In the CTD application dossiers, methods includes the analytical method the quality control section includes selection and method validation. ๆୃĂDUE߭๕ฤԒጨଙዐዊଉ੦ ڦݴဆݛ݆ڦᅙඓۨܔڦthe validation of the established Method selection includes the selection ևݴዷᄲቛ၄ ዐྫײሞํाჺ৯ࡗڍanalytical methods. However, during of analytical methods (HPLC, GC, ᄓኤႠჺ৯ጨଙLj മჺܠthe drug product development, much HPCE and etc.), the screening and ྫሞඓۨݴဆݛ݆ኮമႜକ ߀ڦስĂݛ݆ڦresearch has been done to establish optimization of the chromatographic ৯߾ፕLjසLjဣཥ LjኄၵాඹႴᄲሞDUE߭๕ጨଙዐቛ၄ڪthe analytical method, such as the systems, which includes selection of selection of chromatographic systems, chromatographic column, constitution ǛසႴᄲLjॽසࢆቛ၄Ǜ the improvement of method, etc. Is it and proportion of mobile phase, ৽ײॺ૬ࡗڦǖํाฉݴဆݛ݆ٴ࣮ required to include the development elution program, flow rate, detection Ԉࡤକݛ݆ስࢅݛ݆ᄓኤ߾ፕăݛ݆ history in the dossier in CTD format? wavelength, etc. Besides, during ስԈઔ֑ᆩࢆዖݴဆݛ݆DŽHPLCĂGCĂ If yes, how should it be described? drug development, the analytical
Volume VII 2011 5 ෲᇑᆫࣅLjԈڦDžLjဣཥڪmethod could also be modified due of dissolution test method (The HPCE ၎ፇׯतԲۯto manufacturing process and scale corresponding section of the ઔ֑ᆩࢆዖዹLjࢆዖୁ ăଷڪႾLjୁLjॠ֪հײchanges, all of which are part of attachment in the dossier should be ૩Ljဢྃ तٷዐLjໜጣ߾ᅝݣײanalytical method development and noted) ྔLjሞᄱჺ݀ࡗ optimization process. The screening and ۼLjኄၵڪݴဆݛ݆ႜ߀ܔDetailed data and chromatographic ߀ᄺࣷ optimization of the chromatographic ăڦዐփՆ௨ײspectrum should be provided in the ݛ݆ॺ૬ᇑྜࡗ systems should be provided in the ၄ሞݴဆװcorresponding attachments. ဣཥෲᇑᆫࣅჺ৯ాඹᆌ ݛ݆ڦValidation of Analytical Procedures” ݛ݆ᄓኤၜူLjᅺఇ༹၄“ section, as required by this module. In ,WLVÀH[LEOHKRZWKHDERYHLQIRUPDWLRQ ჺڦჺ৯ాඹăଷLjݛ݆߀ڦስᇑᄓኤ addition, information about method is provided in the dossier, but they ၄ሞݴဆݛ݆ᄓኤၜူLj༬װ৯ాඹᄺᆌ improvement should also be shown should be easy to read and look for. ዐ٪ሞ֑ᆩႪ۩മतײ՚ሞᄱჺ݀ࡗ in the “Validation of Analytical ჺ৯ࡕ้Ljሶᆌॽݛ݆߀ڦXVII. In accordance with the Ⴊ۩ࢫݛ݆ Procedures” section, especially when ၄ሞݛ݆ჺ৯ᇑᄓኤాװჺ৯ాඹڦrequirements of section 3.2.S.4.4 Batch the research results obtained by pre- Analyses, in addition to the batch ඹዐLjཞ้ጀనၵຕ֑ᆩႪ۩മݛ and post-revision methods are used Ljనၵຕ֑ᆩႪ۩ࢫݛ݆ॠڦanalyses report, the data summary ݆ॠ֪ in the drug development, information ॠ֪ࡕႜڦႪ۩മࢫݛ݆ܔLjժڦ֪ of analyses results of each batch about method improvement should also ݛ݆߸ీᆶၳڦԲݴဆLjᅜኤํ߀ࢫܔ should also be provided. Is it also be provided in the method research ዊଉăڦrequired to provide corresponding ੦ׂ and validation. Meanwhile, it should װchromatograms for these data? Are ُևݴాඹᄺᅜ୯ᅜॲݛ๕ be noted which data is obtained by there any requirements for the size of ၄Lj૩සሞवฤԒጨଙኟ࿔Đ3.2.P.5.3ݴ the method before revision and which ᄓኤđၜူᅜଚǖڦthese batches? ဆݛ݆ data is obtained after revision. Besides, ᆶ࠲ዊॠֱݛ݆݀ቛԒߢ९ॲ1 .1 comparative analysis of the test results A: Data summary includes the quality ࿋ዃDžڦDŽጀሞጨଙዐ obtained by the methods before and information of the samples at different ᆶ࠲ዊॠֱݛ݆ᄓኤݛӄतᄓኤ .2 after revision should be conducted in stages, with different scales and ࿋ዃDžڦԒߢ९ॲ2DŽጀሞጨଙዐ order to demonstrate that the improved different purposes (such as validation, ॠֱݛ݆݀ቛԒߢ९ॲ3܈ම .3 method can be used to control product stability, clinical use, etc.) in drug ࿋ዃDžڦquality more effectively. development; it is helpful to understand DŽጀሞጨଙዐ ॠֱݛ݆ᄓኤݛӄतᄓኤԒ܈the overall conditions of product quality. 4. ම ࿋ዃDžڦAbove contents can also be submitted as Different from the batch analyses ߢ९ॲ4DŽጀሞጨଙዐ ຕࢅăڦattachments. For example, the following report, data summary is the summary ሞ၎ᆌॲዐ༵ࠃၘဦ ၄ݛ݆ᅜଳऄቨLjጀᅪᄲՍᇀװ can be listed in the section 3.2.P.5.3 of important quality specification test Validation of Analytical Procedures: results of each batch. The corresponding ֱለनă chromatograms are not necessary to be 1. See Attachment 1 for the development ๆĂߵ4/3/T/5/5಼ॠᄓԒߢᄲ attached, but they should be properly ࠃ಼ॠᄓԒߢྔLj࣏Ⴔ༵ࠃ߲༵߳أreport of related substances test ൱ǖ kept for review. ຕࣹጺLj൩࿚࣏ᄲ༵ࠃڦmethod (The corresponding section of ಼ْॠ֪ࡕ ኄၵ಼ْᄣܔǛڦᆌܔthe attachment in the dossier should XVIII. For drug substances, where ኄၵຕ၎ ଉᆶࢆᄲ൱Ǜ಼ׂڦbe noted) should the detailed research report of ǖຕࣹጺԈࡤକᄱჺ݀ࡗٴSee Attachment 2 for the validation impurities be placed? ࣮ .2 ዐփཞĂփཞࡀఇĂփཞᆩDŽ૩සײ protocol and validation report of A: The impurities study is one of the ዊଉ႑တLjڦDžᄣڪضrelated substances test method important information in the quality ᄓኤĂ࿘ۨႠĂଣ ኝ༹൧ăຕࣹጺڦThe corresponding section of the control research of drug substances. ᆶዺᇀକׂዊଉ) attachment in the dossier should be The major study information includes փཞᇀ಼ॠᄓԒߢLj಼ׂْ߳ዘᄲዊଉ ڦᆌܔࣹጺLjփ၎ڦDQDO\VLVRI ኸՔॠ֪ࡕ noted) DQDO\VLVRILPSXULW\SUR¿OH ᆌྉԍ٪LjᅜԢࢃֱăڍSee Attachment 3 for the development potential process impurities according Lj .3 ሗዊჺ৯ڦᇀᇱଙᄱLjၘဦܔreport of dissolution test method to the synthetic process and analysis of ๆӗĂ The corresponding section of the possible degradation products according Ԓߢᆌݣሞన߲ևݴǛ) to degradation research), establishment ǖሗዊჺ৯ᇱଙᄱዊଉ੦ჺٴattachment in the dossier should be ࣮ and validation of analytical method, and ዘᄲాඹኮᅃLjዷᄲჺ৯႑တԈઔڦnoted) ৯ዐ determination of impurities limit, etc. ߾ڦയሞܔݴဆDŽߵࢇׯ߾ᅝڦSee Attachment 4 for the validation ሗዊ .4 ڦీܔprotocol and validation report In the files in CTD format, the focus ᅝሗዊႜݴဆĂߵইჺ৯
6 CHINA PHARMACEUTICAL NEWSLETTER ॺ૬ࢅڦof section 3.2.S.3.2 is to analyze the 3.2.S.5 Reference Standard, 3.2.S.6 ইׂႜݴဆDžĂݴဆݛ݆ ăڪඓۨڦ܈potential impurities (including organic Packaging Materials and Containers ᄓኤĂሗዊ၌ ۅimpurities, inorganic impurities, and 3.2.S.7 Stability). At present, it is ሞCTD߭๕࿔ॲዐLj3.2.S.3.2ዘ ڦዐയሞׂܔresidual solvents and catalysts) in not required to submit electronically ࢇิׂ߾ᅝࢅই০ჺ৯ the product in combination with the scanned Chromatograms. ሗዊDŽԈઔᆶऐሗዊĂऐሗዊĂ֘ାම manufacturing process and degradation XXI. According to ICH guideline, for वĂ٣ࣅवDžႜݴဆժຫ੦൧Ǘ pathway study and to describe the ॺ૬ࢅڦthe drug product application, the 3.2.S 4.3ዐႴᄲ༵ࠃሗዊݴဆݛ݆ control conditions. The establishment ຎሗዊ੦׃ۅrelative technical documents of drug ᄓኤ႑တǗ3.2.S.4.5ዐዘ and validation information of the ࡕăڦԲჺ৯ܔ۩ᅈLjԈઔڦ܈substance (ie.Section 3.2.S) should ၌ impurity analysis method should be be submitted together in Module provided in section 3.2.S 4.3; the ๆ৵ĂዊଉՔጚଚዐĐݛ݆đၜᄲ 3. For the domestic drug product ՊࡽđLjĐՊࡽđኸనڦfocus of section 3.2.S.4.5 is to explain ൱Đଚݛ݆ application, should this part also be ՊࡽǛڦۆՊࡽǛኸዐࡔᄱڦ the justification of the impurity submitted? Պࡽኸഓᄽߵጲวڦتǖُٴcontrol limits, including the results of ࣮ ՊࡽLjᅜ૧ᇀڦ࿔ॲ࠶ࡀۨጲႜႜڦ ,comparative studies. A: According to the current regulations ۆif the drug substance, which is used रຍ࠶तॠĂ๑ᆩLjᇑዐࡔᄱ XIX. In the specification list, it is ݛڦݥഓᄽᆩأՊࡽփᅃۨᅃ࣮๚Ljڦ for the applied drug product, has been required to “list the number of the ݛ݆ăڦۆapproved in China, it is unnecessary to ݆नྺዐࡔᄱ methods” in the “method” item, what submit its detailed technical documents “number” is it? Does it refer to the ܾๆĂDUE߭๕ጨଙጉႀᄲ൱ܔ in drug product application. In this ڦnumber in the appendix of Chinese മ௬ॺ૬֮ᆅLj൩࿚ॺ૬ጺ situation, the information of drug Pharmacopoeia? ᆅ࣏ӀၜణՊࡽॺ૬ᆅǛ substance should be reflected by the ጱ௮ӲǛۉႴᄲ༵ A: The number here refers to the number corresponding certificates provided by ၜฤԒܔǖྺՍᇀֱለLjॺᅱٴ࣮ made by the company according to the the applicant. ጨଙDŽӀዷ߅ၜణՊࡽLjස3.2.S.2 ิׂ႑ internal file management requirement ዊڦIn section 3.2.P.4, regarding drug တĂ3.2.S.3 ༬Ⴀ६ۨĂ3.2.S.4 ᇱଙᄱ for the convenience of technical substance, it is required to provide ଉ੦Ă3.2.S.5 ܔቷĂ3.2.S.6 Ԉጎଙ management, search and use. It is not the source, relative certificates and ࢅඹഗĂ3.2.S.7 ࿘ۨႠDžമ௬ॺ related to the number in the appendix specification, CoAs from supplier ૬֮ᆅLjຫՊࡽĂฤԒጨଙ of Chinese Pharmacopoeia, unless the ᄓాඹă၄փڦand test report of the drug product ዐሞᄻஓĂ method used in the company is the ጱ௮Ӳăۉmanufacturer. Besides, it may also Ⴔᄲ༵ method in the appendix of Chinese be required to provide the following Pharmacopoeia. information: ܾๆᅃĂJDI࿔ॲᄲ൱LjฤԒव้Lj ၎࠲ጨଙLjनڦఇ4ዐࣷཞ้༵ᇱଙᄱ XX. The dossiers in CTD format require ᄺႴ༵ޏIf the drug substance is refined 4/3/TևݴLjࡔాฤԒव้Lj .1 establishing cross index table for from the approved drug substance ևݴాඹǛ the attached Chromatograms. DFFRUGLQJWRWKHVSHFL¿FUHTXLUHPHQWV ǖӀణമ݆ࡀLjࡔాฤԒवٴ࣮ Is it to establish a general of drug administration route, for ᇱଙᄱLjᅃӯ൧ڦLjස๑ᆩᅙ಼ጚฉ้ Chromatograms index or to H[DPSOHEHUH¿QHGIRULQMHFWLRQWKHQ ူփႴ༵ᇱଙᄱևݴၘဦ႑တLj၎࠲ establish the Chromatograms index it is required to provide the rationale ăڦඹᅜ༵ኤႠ࿔ॲ༹၄ా for each section? Is it required of developing such a refinement ઠᇸĂڦP.4ևݴႴᄲ༵ࠃᇱଙᄱ.3.2 to submit electronically scanned process, the detailed refinement ၎࠲ኤ࿔ॲᅜतኴႜՔጚLj༵ࠃᇱଙᄱ Chromatograms? process and the validation data as ᆩܔॠᄓԒߢᅜतवิׂฆڦฆׂิ well as the comparative study report ॠᄓԒߢLjُྔLj࣏ీႴᄲ༵ڦA: For the convenience of review, it is ᇱଙᄱ of the quality for the drug substance suggested to establish the cross index ࠃසူᇱଙᄱ႑တǖ EHIRUHDQGDIWHUUH¿QHPHQWLQKRXVH إtables including Chromatograms 1. ᆩᇱଙᄱဣሞᅙฉᇱଙᄱए specification of the refined product Lj૩ڥႴᄲܸڦnumber, page number in the application ฉߵवߴᄱ০ for injection and the justification of dossiers and the test contents in the සྺጀพߴᄱ০ᆩLjႴ༵ࠃ߾ WKHLQKRXVHVSHFL¿FDWLRQ ߾ᅝतഄᄓኤጨڦChromatograms. (Numbering should ᅝስᅈĂၘဦ Բჺ৯ጨଙĂܔዊଉڦbe made based on the major items, 2. If the manufacturer of the drug ଙĂമࢫ ጀพᆩా੦Քጚतഄഐ֥ᅈăڦfor example, 3.2.S.2 Production product has established its own in- ׂ ᇱଙᄱۨକా੦ܔInformation, 3.2.S.3 Characterization, house specification for the drug 2. සवิׂฆ ੦ՔጚాڦS.4 Control of Drug Substance, VXEVWDQFHWKHQERWKWKHVSHFL¿FDWLRQ ՔጚLjᆌݴ՚༵ࠃवิׂฆ.3.2
Volume VII 2011 7 ዊଉՔጚăڦof the durg substance from the to ensure that product quality in the shelf ᅜतᇱଙᄱิׂฆ VXSSOLHUDQGWKHLQKRXVHVSHFL¿FDWLRQ life meets the requirements for safety ጱ༵DiQ߭๕ዊۉๆܾĂሞDEFྪበܾ for the drug substance made by the DQGHI¿FDF\DQGLWLVHVWDEOLVKHGPDLQO\ ଉՔጚLjኸݣႜՔጚ࣏ऋॐՔጚǛ drug product manufacturer should be based on the consideration of safety and ǖऋॐՔጚLjऋॐՔጚঢ়ٴprovided. efficacy. The release specification is ࣮ ጀ֩ՔጚLjڦthe standard executed when enterprise SFDAอۨӰքࢫनྺዖ XXII. For the ChP format specification releases product; it aims to increase ਏᆶഽႠࢅሀຐ૰ă electronically submitted to the CDE certain assurance factor in order for that website, is it the release specification ܾๆෙĂ൩࿚සࢆݣႜՔጚࢅऋ the product quality after release can RUWKHVKHOIOLIHVSHFL¿FDWLRQ" ॐՔጚLjܾኁኮक़ᆶࢆဣǛሞۨՔ ݔྷǛ܈၌ڦ ጚ้ᆌසࢆӝՔጚ FRPSO\ZLWKWKHVKHOIOLIHVSHFL¿FDWLRQ A: It refers to the shelf-life specification. and it is established mainly based on the ǖCTD߭๕ডኮĖᄱጀ֩࠶ٴ࣮ After being reviewed and approved quality control data and the long-term Ӹ݆ėॲܾ၎ᆌాඹඓକݣႜՔጚࢅ by SFDA, the shelf-life specification stability study data of many batches ऋॐՔጚăยۨݣႜՔጚLjᅃݛ௬ྜ becomes registration specification of of products after the process is stable. ײࡗڦକዊଉ༹ဣLjଷᅃݛ௬༹၄କዊଉ the product which is mandatory and Due to the different purposes of the two ၳڟ࠶ăऋॐՔጚᆩᇀᄱٗݣႜ binding. specifications, their items and limits ጀ֩ՔጚLjڦཞᇀణമڪዊଉ੦Ljڦ are also different. For example, for the ࢇޙᄲඓԍׂሞᆶၳాዊଉڦXXIII. How should one understand the ഄణ impurities limit, it is considered that UHOHDVHVSHFL¿FDWLRQDQGWKHVKHOIOLIH Ҿඇᆶၳᄲ൱LjഄۨዷᄲएᇀҾඇᆶ the impurity content of product will be ݣׂׂิܔVSHFL¿FDWLRQ":KDWLVWKHUHODWLRQVKLS ၳႠ୯ǗݣႜՔጚഓᄽ increased in the process of storage, so ྺᄱݣႜڦՔጚLjഄణڦbetween them? How to control the ႜ้ኴႜ UHTXLUPHQWVIRUWKHUHOHDVHVSHFL¿FDWLRQ ԍڦࢇऋॐՔጚሺेᅃۨޙlimit ranges when establishing the ࢫዊଉీࠕ will be generally tighter than the shelf- ߾ᅝ࿘಼ۨܠVSHFL¿FDWLRQV" ၃ဣຕLjഄۨዷᄲएᇀ OLIHVSHFL¿FDWLRQ ዊଉॠᄓຕत࿘ۨႠᄓຕڦA: Compared with the corresponding ࢫׂ ၜణतڦփཞLjࠤՔጚڦᆩణڦcontents in Annex 2 of the Drug XXIV. Can the applicants design relevant ăܾኁ ڟLj୯܈၌ڦᄺࣷᆶփཞLj૩සሗዊ܈Registration Regulation, the release tables by themselves and add them ၌ ሗዊࡤଉࣷᆶሺेLjݣڦዐׂײspecification and the shelf-life into the dossier in CTD format as ݣዃࡗ specification are specified in CTD needed? ႜՔጚཚԲऋॐՔጚᄲჹ߭ă ޏ၎࠲߭ڦformat. The establishment of release A: Relevant tables in the dossier in CTD ܾๆ຺ĂDUEጨଙዐ specification not only completes the format can be properly adjusted as ߵႴᄲጲႜยऺईሺे߭Ǜ ၎࠲߭ᅜڦǖCTDጨଙዐٴquality system, but also shows the needed. When necessary, the tables can ࣮ ኝLjՂᄲ้Ljᄺጲႜยۙړquality of process management. The be designed by the applicant. It should ߵႴᄲ ၎࠲႑တᅃۨڦᄲጀᅪླྀ४߭ዐڍshelf-life specification is used in the be noted that relevant information as ऺLj ၄ă༹ڟڥ߭ዐڦquality control from release to the end recommended in CDT format must be ᄲሞጲႜยऺ of expiry date, it is equivalent to the shown in the tables designed by the FXUUHQWUHJLVWUDWLRQVSHFL¿FDWLRQ LWDLPV applicant.
ࡴԈڶEvent of CCPIE И֢ԛ哦֢எсࡶИ 16াዐࡔࡔाᅅᄱDŽ߾ᄽDžڼ The 16th China International Pharmaceutical ,QGXVWU\([KLELWLRQ &+,1$3+$50 ZLOOEH ቛબࣷᷣरຍୁࣷDŽCHINA- PHARM 2011 2011 KHOGDW6KDQJKDLIURP2FWREHUWR Džॽᇀ 10ሆ25න28නሞฉ࡛ਉӸ
The 16th China International Center from October 25 to 28, 2011. ᆯዐࡔᅅᄱࡔाୁዐ႐ࢅ܅ܻܠ 16াዐڼڦቛબDŽฉ࡛Džᆶ၌ࠅິዷӸސ Pharmaceutical Industry Exhibition (CHINA-PHARM 2011) co-organized CHINA-PHARM has developed into a ࡔࡔाᅅᄱDŽ߾ᄽDžቛબࣷᷣरຍୁࣷ by China Center for Pharmaceutical famous international trade fair which is DŽCHINA-PHARM 2011Džॽᇀ201110ሆ25 International Exchange and Messe the most authoritative, representative න28නሞฉ࡛ႎࡔाձબዐ႐ਉӸă ቛᅙׯ݀ڦDüsseldorf (Shanghai) Co., Ltd. will be and influential in pharmaceutical field CHINA-PHARMঢ়ࡗๆब Ⴀࢅᆖၚ૰پheld at Shanghai New International Expo for more than a decade. The space of ྺሞᅅᄱଶᇘፌਏྰႠĂ
8 CHINA PHARMACEUTICAL NEWSLETTER 2 ኪఁࡔाႠጆᄽቛࣷăৃቛબ௬ओॽڦ CHINA-PHARM 2011 is 28,000 m , and Technology International Training will the fair will welcome over 500 exhibitors be held from October 25 to 26. The ሺ28,000ೝݛLjॽᆓઠᇈ500ॆቛฆࢅ ࡔڤࡔाኪఁഓᄽᅜतܠand 20,000 visitors. Renowned exhibitors Chinese Medicine Injection Forum to 20,000ఁ࠵ዚăዚ ࢇႎޙॽቛ๖ഄڪand the national pavilions from Germany be held on October 27.In the meantime, ࡔॆቛཷĂᆈࡔࡔॆቛཷ GMP ᄱऐႁࢅยԢă܋ߛڦand UK will expand their stand space to World Health Organization (WHO) ᄲ൱ CHINA-PHARM 2011ቛબࣷक़Ljॽ֒ exhibit the state-of-the-art devices and and International Drug Information ᇑरຍୁࣷLjසᇑࡔाᄱ߾ۯऄܠ၄ዚװ equipment which meets the requirement Association (DIA) will also organize ࣷđॽٷዐࡔײĐࡔाᄱ߾ڦၹࣷࢇӸײ of new GMP. training sessions during the fair and ᇀ10ሆ2527නਉӸLjዷ༶Đࠌၛඇ൰ፌ CHINA-PHARM 2011 will present release more information to the industry. ॅํ७ঢ়ᄓLjศ܈ဆႎӲGMPํแđǗᇑ ଙၹޤthe trade visitors with more concurrent ዐࡔ๋ᄱॠۨჺ৯ᇾࢅࡔाᄱᆩ ଙޤĐᄱᆩڦacademic and technology forums and On the basis of the experience of ࣷDŽዐࡔDžDŽIPEC ChinaDžࢇፕ ࣷđॽᇀ10ሆ26නਉӸǗ10ሆ25ٷevents. ISPE-CCPIE China Conference, preceding 15 Exhibitions, The 16th ᄱԈ which has cooperated with CHINA- China International Pharmaceutical 26න࣏ॽਉӸĐዐࡔᄱᇑল৫ࡔारຍಢ ჟđǗ10ሆ27නਉӸĐጀพवิׂዊଉ࠶ PHARM, will be held in Shanghai Industry Exhibition continues to ჺ༪ࣷđǗ๘হ࿐ิፇኯDŽWHODžࢅெࡔᄱ from October 25 to 27, 2011 with the innovate and tries to build up a good ႑တၹࣷDŽDIADžᄺॽሞቛࣷक़ፇኯಢჟ theme “Share global best practices and platform of exhibition, communication ࣷLjၠႜᄽ݀ք߸ܠ႑တă explore the implementation of new and coordination for the domestic and ๆୃাዐࡔࡔाᅅᄱDŽ߾ᄽDžቛબࣷڼ foreign enterprises, has a positive effect ฉLjփإঢ়ᄓएڦGMP”. National Institutes for Food and ᷣरຍୁࣷሞമๆা ቛڦॺᅃ߲ଆࡻٲႎLj૰ኛྺዐྔഓᄽظ Drug Control and IPEC China will hold upon promoting Chinese pharmaceutical 2011 China Pharmaceutical Excipient equipment, and makes a outstanding ๖ĂୁĂࢇፕೝLjྺ༵ߛࡔᄱഓᄽ ٝፕᆩLjྺླྀڦࣩओट݀پ߸ႎ࣑ڦRegulatory Conference on October contributions to the implementation of ยԢ ࠋ၅ăڦแፔओटํڦࡔGMPۯ .Pharmaceutical and Cleanroom the new GMP.26
Special Focus ЎࣙЊங ք݀ڇ7KH/LVWRI7RS(QWHUSULVHVRI&KLQHVH3KDUPDFHXWLFDO ࡔᄱӥഽഓᄽఁ Industry Released
28াDžڼOn August 17, 2011, the "2011 (28th) Pharmaceutical Industry in 2010, which 20118ሆ17නLjĐ2011DŽ Annual Meeting of the Information of comprehensively ranked the business ඇࡔᄱ߾ᄽ႑တࣷđሞฉ࡛ਉႜăࣷ LjඇڇNational Pharmaceutical Industry" was scale of the pharmaceutical enterprises ฉ݀քକ2010ዐࡔᅅᄱ߾ᄽTOPӽ held in Shanghai. The Meeting released in the previous year; the list of the top 50 ௬କฉ܈ᅅᄱ߾ᄽഓᄽঢ়ᆐ൧ă the list of TOP enterprises of China’s enterprises is as follows. ഄዐമ50࿋ಇఁසူǖ
ഓᄽఁ ഓᄽఁ NO Company Name NO Company Name ᄙጱॿᄱᄽणཷᆶ၌ࠅິ ྰߛणཷᆶ၌ࠅິ 1 Yangtze River Pharmaceutical Group 8 Weigao Holding Company Limited. Ⴊኟᄱᄽणཷࠣݻᆶ၌ࠅິ ሊళӣᄱणཷࠣݻᆶ၌ࠅິ 2 Xiuzheng Pharmaceutical Group 9 Yunnan Baiyao Group Co., Ltd. ࡘᄱणཷᆶ၌ࠅິ ۫ԛᄱणཷࠣݻᆶ၌ࠅິ 3 Harbin Pharmaceutical Group Holding Co., Ltd. 10 Northeast Pharmaceutical Group Co., Ltd. ฉ࡛ᅅᄱDŽणཷDžᆶ၌ࠅິ ዐࡔᅅᄱणཷጺࠅິ 4 Shanghai Pharmaceuticals Holding Co., Ltd. 11 China National Pharmaceutical Group Corporation ็ᄱणཷᆶ၌ࠅິ өܺᅅᄱԍॳᆶ၌ࠅິ 5 CSPC Pharmaceutical Group Limited 12 Bayer HealthCare ࡴዝࣀ۫ᅅᄱणཷᆶ၌ࠅິ टणཷᆶ၌ࠅິ 6 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. 13 Taiji Group Co., Ltd. ࣀԛᄱणཷᆶ၌ࠅິ ཀৄཀ๗૰णཷᆶ၌ࠅິ 7 North China Pharmaceutical Group Corporation 14 Tianjin Tasly Group Co., Ltd.
Volume VII 2011 9 ཀৄዐႎᄱᄽणཷࠣݻᆶ၌ࠅິ 33 ฉ࡛ஆᄱᆶ၌ࠅິ 15 Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Shanghai Roche Pharmaceutical Co., Ltd.
ԛມᄱᄽࠣݻᆶ၌ࠅິ 34 ࡴዝෘ౷ݤҾྤ༬௷ิᄱᆶ၌ࠅິ 16 Beijing Double-Crane Pharmaceutical Co., Ltd. Hangzhou Sano¿-Aventis Minsheng Pharmaceutical Co., Ltd.
࠽ዝӣሊᄱࠣݻᆶ၌ࠅິ 35 ႎࢇׯ੦ࠣणཷᆶ၌ࠅິ 17 Guangzhou Baiyunshan Pharmaceutical Co., Ltd. NHU Holding Group Co., Ltd.
ഋᄱᆶ၌ࠅິ 36 ࢁሷ᭳ᆋᄱणཷᆶ၌ࠅິ 18 Qilu Pharmaceutical Co., Ltd. Heze Ruiying Pharmaceuticals Group Co., Ltd.
ዩ࡛Ӻᄱࠣݻᆶ၌ࠅິ 37 ዐࡔཚᆩरຍDŽणཷDž੦ࠣᆶ၌ሴඪࠅິ 19 Zhuhai United Laboratories Co., Ltd. China General Technology (Group) Holding Co., Ltd.
ࣹඦणཷᆶ၌ࠅິ 38 ళᄱणཷࠣݻᆶ၌ࠅິ 20 Huiren Group Co., Ltd. Lunan Pharmaceutical
ᄞᄱᆶ၌ࠅິ 39 ళᅅᄱׂᄽDŽणཷDžᆶ၌ሴඪࠅິ 21 Reyoung Pharmaceutical Co., Ltd. Nanjing Pharmaceutical Co., Ltd.
ฉ࡛ް႓ᅅᄱDŽणཷDžࠣݻᆶ၌ࠅິ 40 ඦࢅDŽणཷDž݀ቛᆶ၌ࠅິ 22 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Renhe (Group) Co., Ltd.
ኅॿᅅᄱࠣݻᆶ၌ࠅິ 41 ெᄱᄽࠣݻᆶ၌ࠅິ 23 Zhejiang Medicine Co., Ltd. Kangmei Pharmaceutical Co., Ltd.
ᄱᆶ၌ࠅິ 42 ॿ໋ࡸ෧ᄱᄽࠣݻᆶ၌ࠅິڜୄॿูኆԐ 24 Heilongjiang ZBD Pharmaceutical Co., Ltd. Jiangsu Hanson Pharmaceutical Group
ᄱᄽࠣݻᆶ၌ࠅິ 43 ݯ෧ᆮຯਸ਼ԲDŽዐࡔDžཨጨᆶ၌ࠅິج຺ 25 Sichuan Kelun Pharmaceutical Co., Ltd. Fresenius Kabi (China) Investment Co., Ltd.
ဇҾᄘ෧ᄱᆶ၌ࠅິ 44 Үຯ૧ᄱᆶ၌ࠅິ 26 Xi'an-Janssen Pharmaceutical Co., Ltd. AstraZeneca Pharmaceutical Co., Ltd.
ኅॿ࡛ኟᄱᄽࠣݻᆶ၌ࠅິ 45 ۫ႎࣀᅅᄱणཷᆶ၌ሴඪࠅິ 27 Zhejiang Hisun Pharmaceutical Co., Ltd. Shandong Xinhua Pharmaceutica Co., Ltd.
ཀᄱᄽࠣݻᆶ၌ࠅິٷ࣪ᄱᆶ၌ࠅິ 46 ॿ໋ኟ 28 P¿zer Pharmaceutical Co., Ltd. Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ࣀාෙ৵ᅅᄱࠣݻᆶ၌ࠅິ 47 ံำᄱᄽᆶ၌ࠅິ 29 China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. Simcere Pharmaceutical Co., Ltd.
ඦᄱᄽणཷᆶ၌ࠅິ 48 ૢዩᅅᄱणཷࠣݻᆶ၌ࠅິޤ 30 Furen Medicine Group Livzon Pharmaceutical Group Inc.,
۫օᄱᆶ၌ࠅິ 49 ॿ໋ᇹणཷᆶ၌ሴඪࠅິ 31 Shandong Buchang Pharmaceutical Co., Ltd. Jiangsu Kanion Pharmaceutical Group Co., Ltd.
ॿ໋࢛ᅅᄱࠣݻᆶ၌ࠅິ 50 ࢋళูྡྷဇᄱࠣݻᆶ၌ࠅິ 32 Jiangsu Hengrui Medicine Co., Ltd. Henan Wanxi Pharmaceutical Co., Ltd. (August 24, 2011) DŽ20118ሆ24නDž
The Export of Western Medicine Products Witnessed a ฉӷࡔဇᄱૌׂ੨ 5DSLG*URZWKLQWKH)LUVW+DOIRI ߛሺ
ܮIn the first half of 2011, China's total maintain a rapid pace of development. ฉӷLjࡔဇᄱૌׂ੨ጺ גޗ210.56ᅢெᇮLjཞԲሺ31.19%Ljሺٳ import and export value of western LjीჄԍۅ5.74߲ӥݴޗVH[SRUWRI ࡗ2010ඇሺ medicine products amounted to $ 21.056 ,QWKH¿UVWKDOIRI&KLQD billion, an increase of 31.19% in equal western medicine products topped 13.136 ߛ݀ቛཀྵăཞ้Lj੨ຕଉཞԲሺ terms, and up by 5.74 percentage points billion U.S. dollars, up by 27.05 percent, 17.73%Ljೝॏ߭ཞԲሺ11.43%Ljኄ Ⴔ൱ሞ࿘ڦဇᄱૌׂܔcomparing with the 2010 full-year growth and maintained a high growth trend since ݒᆙࡔाׇ rate. The momentum of rapid development 2010. ۨሺLjࡔဇᄱૌׂࡔाஹᅟᆶྭी ă܈ቛ݀ڦstill maintained. Meanwhile, the import In the first half of 2011, the exports of Ⴤԍড 131.36ܮexport volume and the average western medicine products continue to ฉӷLjࡔဇᄱૌׂ੨ & price increased by 17.73% and 11.43% improve, the exports grew by 25.02%, the ᅢெᇮLjཞԲሺ27.05%Ljԍକ2010 ߛሺༀăڦUHVSHFWLYHO\LQHTXDOWHUPVZKLFKUHÀHFWV average export price increased by 1.63%, ᅜઠ that the international market’s demand and it is gratifying that the volume and price ฉӷࡔဇᄱૌׂ੨ीჄၠࡻLj for Western medicine products is growing still both increased. However, the price- ੨ଉሺ25.02%Lj੨ॏሺ1.63%Lj ٷෙڍဠਆ௬ăڦsteadily, and China’s international trade of volume relation of three major categories ጺ༹ฉԍକଉॏഋื Ljᇱଙᄱࢅิࣅٷଉॏ࠲ဣՎࣅডڦwestern medicine products is expected to of products changed greatly, the exports of ૌฆ
10 CHINA PHARMACEUTICAL NEWSLETTER APIs and biochemicals rose in volume while North America remain to be China’s ᄱ੨ଉืॏۚLjഄዐᇱଙᄱ੨ຕଉሺ drop in price, the export volume of APIs major export markets with a share of 35.16%Ljॏ߭ူۚ4.83%Ǘิࣅᄱ੨ଉ ăဇׯᄱሶ%43.19ۚူޗٷincreased 35.16%, but the prices fell 4.83%; 86.52%. The volume and price of export ԓሺ96%Ljॏ biochemical exports jumped up by 96%, but to Asian and European market both ၎ݒLj੨ଉԓই68.42%Lj੨ॏԓሺ Ljဇׯᄱ੨9.45ᅢெੂܮthe average price plummeted by 43.19%. increased, the export to Asian market 314%ăٗ੨ Ǘᇱଙᄱ੨%30.71ٳLjߛٷፌޗWestern patent medicine, by contrast: export amounting to $ 5.678 billion, an increase ᇮLjሺ Ǘิࣅᄱ੨%28.63ྺޗvolume plummeted by 68.42%, while the of 31.72%; exports to European markets 110.43ᅢெᇮLjሺ average export price rocketed by 314%. is $ 3.853 billion, up by 22.95%. While 11.49ᅢெᇮLjሺޗྺ11.34%ă From the perspective of export value, the the market conditions in North America ฉӷLjࡔဇᄱૌׂ੨185߲ࡔ ൶ăჱዞĂ౹ዞࢅԛெዞᅈںexport of Western patent medicine is $ 945 were slightly different, exports grew ॆࢅ ăჱ౹ׇଉ%86.52ٳዷᄲׇLjԲዘڦ੨ million, which enjoyed the greatest increase 26.33%, but the average export price fell 56.78ᅢெٳܮჱዞׇ੨ܔॏഋืLj up to 30.71%; that of APIs is 11.043 billion by 13.83%, the final exports value is $ ྺܮ౹ዞׇ੨ܔᇮLjཞԲሺ31.72%Ǘ U.S. dollars, an increase of 28.63%; that 1.835 billion, an increase of only 8.86% 38.53ᅢெᇮLjཞԲሺ22.95%ăԛெዞ of biochemicals is $ 1.149 billion, up by in equal terms. The exports to the fastest- ׇ൧ฎᅴLj੨ଉሺ26.33%Lj੨ॏ 11.34%. growing Oceania market increased by 18.35ᅢெྺܮඐူইକ13.83%Ljፌዕ੨ 140%, while exports to Latin America ᄝዞׇሺፌٷV:HVWHUQ ᇮLjཞԲৈሺ8.86%ă QWKH¿UVWKDOIRI&KLQD, Ljઙۡெዞሶᅜ%140ٳߛޗሺܮmedicine products have exported to 185 market, which ranked second in growth Lj੨ (August 18, 2011) (ă (20118ሆ18නܾڼ࿋ଚޗሺڦcountries and regions. Asia, Europe and rate, increase by 46.16%. 46.16%
Table ǖThe export statistics of China's Western medicine products in the First half of 2011 Quantity Unit: ten thousand tons Value Unit: U.S. $ ࿋ǖᅢெᇮڇܮāāূܖ࿋ǖྤڇǖ2011ฉӷዐࡔဇᄱૌฆ੨ཥऺ ຕଉ Export Growth rate in Export Growth rate in Average Growth rate in Commodity Name Proportion amount equal terms (%) value equal terms (%) Price equal terms (%) ఁ Բዘ ཞԲ ॏ ཞԲ ܮ੨ଉ ཞԲ ੨ Western Medicine 335 25.02 131.36 27.05 3.92 1.63 100 ဇᄱૌ APIs of Western Medicine 307 35.16 110.42 28.63 3.6 -4.83 84.06 ဇᄱᇱଙ Western patent medicine 95 -68.4 9.45 30.71 9.49 3.14 7.2 ဇׯᄱ Biochemicals 17.73 96 11.49 11.34 6.48 -43.2 8.47 ิࣅᄱ
Provided by Servier (Tianjin) Pharmaceutical Co., Ltd. แྼჯDŽཀৄDžᄱᆶ၌ࠅິࠃߡ Special column ࢤংЊߙ
ๆ຺াዐࡔᄱბࣷĊڼThe Assessment Results of “The 14th China Đ 3KDUPDFHXWLFDO$VVRFLDWLRQ6HUYLHU3UL]HIRU Volume VII 2011 11 ૬Đዐࡔᄱბࣷ-แྼჯ൞ᄱظcreation of the “CPA-Servier Prize for Young Chemistry”, was established to help ༵ࠌཞ Ljڞዐࡔᄱბࣷଶڟڥॺᅱࢫ૬नڦInvestigators in Medicinal Chemistry”. This the young postgraduates from depressed ࣅბঃđ ૰ኧLjঃၜٷڦproposition was accepted immediately areas improve their levels of scientific ༬՚ޭ๚ቧࢅᇾ๗ ௷and supported strongly by the CPA, research. ೠᅃْLj༵ࠃ࿋इঃኁ15000ᇮට ঃূྺ10000ᇮDžLjኼڦespecially inspired by Pr. ZHANG Li-He, Fourteen years since its creation, “CPA - ԼঃূDŽ2005ᅜമ the former Vice-President of the CPA. It is Servier Prize for Young Investigators in ሞࠞࡔᆫႯ൞ᄱࣅბ߾ፕኁ૬ፁᇀ ࡔాዂ૰ᇀႎᄱჺ৯ăٗ2004ഐLjᆼሺยକ an annual prize and provides RMB 15,000 Medicinal Chemistry” has made positive ĐዐࡔᄱბࣷĊแྼჯ൞ᄱࣅბጆၜჺ৯ for each winner (RMB 10,000 before contributions in the encouragement of ൟຬ๗ڦ൶ںጨዺၜణđLjᅜӻዺઠጲೖઓ 2005). It aims to encourage the outstanding outstanding young investigators in novel ิࢅձ๗ิ༵ߛჺೝă young investigators in Medicinal drugs research and development. As ॺๆ຺ઠLjĐዐࡔᄱბࣷĊแྼჯ൞ظ Chemistry to dedicate to drug research the most important prize in medicinal ᄱࣅბঃđྺࠞዐࡔᆫႯ൞ਸቛႎᄱ ࠋ၅ăፕྺዐࡔघࢅڦbased on domestic circumstances in chemistry that encouraging and rewarding ჺ৯߾ፕፔକओट ঃၜLjዐڦፌዘᄲڦChina. Since 2004, an additional prize, the young researchers in China, CPA and ঃ൞ᄱࣅბ߾ፕኁ ںCPA - Servier Special Funded Project French Servier Research Institute will ࡔᄱბࣷᇑ݆ࡔแྼჯჺ৯ᇾॽࣷीჄ“ for Young Investigators in Medicinal continue to sustain the Prize. Ӹူඁă Notes: All Chinese information in Newsletter extracted from Newspapers and Internet. All English articles are the translations from the Chinese version. Read the electronic version of the newsletter please visit http://www.ccpie.org Ԣ!ጀǖ Newsletterዐᆶዐ࿔႑တቌጲԒतྪஏăᆈ࿔ဣዐ࿔ᅳă ྪበhttp://www.ccpie.orgکጱӲNewsletterለબ൩ۉ China Center for Pharmaceutical International Exchange (CCPIE) Servier (Tianjin) Pharmaceutical Co., Ltd. ዐࡔᅅᄱࡔाୁዐ႐ แྼჯDŽཀৄDžᄱᆶ၌ࠅິ Address: Room 1106, 11th Floor, Office Building B, Maples International Center, Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd No. 32, Xizhimen North Street, Haidian District, Beijing, 100082, P.R.C. Ring Middle Road, Chaoyang District, 100020 Beijing, China ᄞ൶۫ෙ࣍ዐୟ2ࡽ࣍൰ূබዐ႐ဇ୍7֫וઢࡔाዐ႐Bፗႀጴ୍11֫1106 ! ԛށন32ࡽٷ൶ဇோԛۏዐࡔԛ࡛ ᆰՊǖ100082 ! ᆰአՊஓǖ211131 Tel: 010-8221 2866 Tel: 010-6561 0341 Fax: 010-8221 2857 Fax: 010-6561 0348 Email: [email protected] E-mail: [email protected] Website: www.ccpie.org Website: www.servier.com.cn 12 CHINA PHARMACEUTICAL NEWSLETTER