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CHINA PHARMACEUTICAL NEWSLETTER แྼჯ)ཀৄDž዆ᄱᆶ၌ࠅິ З֡Ԛ哦֡ଢ଼рࡗЗڵ Volume VI Published by China Center for Pharmaceutical International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd. ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆۯᇵ ևຈᄱ೗Đଇٶଇॺđጆၜႜۯ ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ Ӹࠅཐ݀քĖ࠲ᇀᄱ೗๬ႜ Քጚገኟᆶ࠲๚ᅓڦཚኪė CFDA Mobilized and Deployed Special Action of "2 ESTABLISHMENTs & 2 AGAINSTs" for Drugs CFDA General Office Issued the "Notice on Issues concerning the Regularization of Interim Drug Standards" On July 17, 2013, CFDA held a work conference deploying the special action "2 ESTABLISHMENTs & 2 AGAINSTs" for drugs which requires Food and Drug Administration departments of all areas to focus on, in the next half of 2013, a nationwide special action featuring the UHVROXWH�¿JKW�DJDLQVW�LOOHJDO�GUXJ�SURGXFWLRQ� & dis t r ibu t ion , and the suppor t for standard construction of drug production & distribution and supervision mechanism construction. CFDA Vice Minister Yin Li urged all local departments to set great store to In accordance with the relevant provisions of the "Regulations for Implementation of the Drug Administration Law of the People's Republic of China," CFDA has organized the Chinese Pharmacopoeia Commission to carry out the review for the Regularization of Interim Drugs Standards. To expedite this practice and fully eliminate Interim Drug Standards, on July 11, 2013, CFDA *HQHUDO�2I¿FH�LVVXHG�WKH��1RWLFH�RQ�,VVXHV� concerning the Regularization of Interim Drug Standards". The Notice requires Food and Drug Administration departments of all provinces, autonomous regions and municipalities 2013౎7ሆ17නLjࡔॆ๋೗ᄱ೗॔۽࠶૙ ጺਆቻਸᄱ೗Đଇٶଇॺđጆၜႜۯۯᇵևຈ ߾ፕࣷᅱLjᄲ൱߳ںٗৃ౎7ሆڟ12ሆLjणዐ ӷ౎้क़Ljሞඇࡔݔྷਸቛᅃׇᅜჹૣٶऍᄱ ೗ྵ݆ิׂĂٶऍᄱ೗ྵ݆ঢ়ᆐĂेഽᄱ೗ิ ׂঢ়ᆐࡀݔॺยࢅᄱ೗॔࠶ऐ዆ॺยྺዷᄲా ඹڦĐଇٶଇॺđጆၜႜۯă ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆޭਆ׊ᆄ૰ᄲ൱ ߳ںᄲߛ܈ዘ๫ኄْጆၜႜۯLjፇኯ૰ଉLjܔᄱ ೗ิׂĂঢ়ᆐഓᄽĂዐᄱ֌ጆᄽ๨ׇࢅኑ໯ڦಇ ֱĂॠֱLjֱ تᅃ಼ྵ݆ྵࡀႜྺLjᅎໃᅃ಼ዘ ٷӄॲLj঴ਦᅃ಼ᆖၚᄱ೗Ҿඇڦ཭؜࿚༶ăࡔ ॆ๋೗ᄱ೗॔۽࠶૙ጺਆޭਆ׊࿲៉ᄲ൱Ljጆၜ ႜۯዐLjᄲॕਦჹ׳ྵ݆ྵࡀႜྺĂॕ ਦ೸࠼ྵ ݆ྵࡀഓᄽĂॕ ਦቻ࣮࿚༶ׂ೗ăDŽ2013-07-17Dž ߵ਍Ėዐࣀට௷ࠌࢅࡔᄱ೗࠶૙݆ํแ ཉ૩ėڦᆶ࠲ࡀۨLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺ ਆፇኯࡔॆᄱۆ྿ᇵࣷਸቛᄱ೗๬ႜՔጚڦ ገኟอֱ߾ፕăྺे੺ᄱ೗๬ႜՔጚገኟอ ֱ߾ፕLjඇ௬ൽၩᄱ೗๬ႜՔጚLj2013౎7ሆ 11නLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆӸࠅཐ݀ք Ė࠲ᇀᄱ೗๬ႜՔጚገኟᆶ࠲๚ᅓڦཚኪėă ཚኪᄲ൱ู߳Ăጲዎ൶Ă኱ါ๨๋೗ᄱ೗ ॔۽࠶૙ਆ৑੺ܔါ൶ాᄱ೗๬ႜՔጚ൧઄৊ ႜൣ૙Ljཚኪ၎࠲ᄱ೗ิׂഓᄽՂႷᇀ2013౎ 8ሆ31නമ༵؜ገኟฤ൩ăᄲӀቷĖ࠲ᇀํแ Ĕᄱ೗ጀ֩࠶૙Ӹ݆ĕᆶ࠲๚ᅓڦཚኪėDŽࡔ ๋ᄱ॔ጀĒ2007ē596ࡽDžڦᆶ࠲ᄲ൱Ӹ૙ါ ൶ాᄱ೗๬ႜՔጚገኟฤ൩Ljժᇀ2013౎9ሆ 30නമॽ໯๴૙ڦฤԒጨଙໃ঍ࡔॆᄱۆ྿ᇵ ࣷLjཞ้ॽᇈ೺࿄༵؜ฤ൩ڦ೗ዖൣڇԒໃࡔ this special action, organize designated personnel to invest igate and inspect drug manufacturers and distributors, Chinese medicinal herbs markets and clinics, to bring to justice a number of illegal activities and violations, transfer a number of major cases, and resolve a number of outstanding problems affecting drug safety. CFDA Vice Minister Wu Zhen required that the special action must resolutely punish the illegal acts, expose the enterprises violating laws and regulations, and recall the problematic products. (2013-07-17) to sort out as soon as possible the Interim Drug Standards within their jurisdiction and no t i fy re levan t pharmaceut ica l manufacturers to submit, prior to August 31, 2013, the regularization applications, which shall be handled in accordance with the relevant requirements of the "Notice on Issues concerning the Implementation of the Provisions for Drug Registration" (GSYJZ [2007] No. 596), and the accepted application documents should be delivered to the Chinese Pharmacopoeia Commission prior to September 30, 2013, meanwhile the list of drugs failing to be submitted for application before this deadline shall be reported to CFDA Department for 2013 2 CHINA PHARMACEUTICAL NEWSLETTER ॆ๋೗ᄱ೗॔۽࠶૙ጺਆᄱ೗ࣅጏ೗ጀ֩ ࠶૙ິLjጺਆॽᅈ݆םၨ๬ႜՔጚࢅᅈ਍ ޿๬ႜՔጚิׂᄱ೗ڦ಼ጚ࿔ࡽă ཚኪᄲ൱ู߳Ăጲዎ൶Ă኱ါ๨๋೗ ᄱ೗॔۽࠶૙ਆ۽ٝ၎࠲ᄱ೗ิׂഓᄽߛ ܈ዘ๫Ljൎํሺഽሴඪᅪ๎LjӀ೺ฤԒLj ዷۯᇑูपᄱ೗॔۽࠶૙ևோࢅࡔॆᄱۆ ྿ᇵࣷࠏཚLjओटದࢇྜׯᄱ೗๬ႜՔጚ ገኟ߾ፕă DŽ2013-07-11Dž Registration of Drugs and Cosmetics. This department shall revoke the interim drug standards and their pursuant production DSSURYDO�FHUWL¿FDWHV� The Notice requires Food and Drug Administration departments of all provinces, autonomous regions and municipalities to urge the re levant pharmaceut ical manufacturing enterprises to attach great importance to this practice, effectively enhance the sense of responsibility in regular reporting and active communication with provincia l drug adminis t ra t ion departments and the Chinese Pharmacopoeia Commission, and actively cooperate with the work for regularization of Interim Drug Standards. (2013-07-11) ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆӸࠅཐ ݀քĖ࠲ᇀ৊ᅃօेഽࡤ੗ځᅺް ݛ੨ޜමᅂĂްݛ߆֥ೌࢅްݛں ݰ౷ḇೌࠔၨ࠶૙ڦཚኪė ๋೗ᄱ೗॔۽࠶૙࠽ߢ֪॔ ဣཥޮ߃ෙഥᇆॆ௃༹ CFDA General Office Issued the "Notice on Further Strengthening the Management of Purchasing and Distribution of Compound Codeine-Containing Oral Solutions, Compound Liquorice Tablets and Compound Diphenoxylate Tablets" Food and Drug Administration Advertising Monitoring System Covers More Than Three Thousand Media 2009౎Ljᇱࡔॆ๋೗ᄱ೗॔۽࠶૙ਆᆇ ݀Ė࠲ᇀൎํेഽևݴࡤ༬๺ᄱ೗ްݛ዆व ၨ๳࠶૙ڦཚኪėDŽࡔ๋ᄱ॔Ҿ[2009]503 ࡽDžLjܔࡤ੗ځᅺްݛ੨ޜමᅂĂްݛ߆֥ ೌĂްݛںݰ౷ḇೌڦࠔၨ࠶૙༵؜କᄲ ൱Ljܔܴ዆ُૌᄱ೗ٗᄱᆩർڢୁ฿ࢅર ᆩLjࣩ݀କओटፕᆩăྺ৊ᅃօेഽܔฉຎ ᄱ೗ڦࠔၨ࠶૙Ljԍቱࠅዚॳ੃Lj2013౎7 ሆ8නLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆӸࠅཐ ݀քཚኪLjᄲ൱ู߳Ăጲዎ൶Ă኱ါ๨๋೗ ᄱ೗॔۽࠶૙ਆDŽᄱ೗॔۽࠶૙ਆDžᄲ׼Ⴤ ླྀ৊ُၜ߾ፕLjेഽᄱ೗ิׂഓᄽၨ๳࠶ ૙Ǘჹ߭ᄱ೗ঢ়ᆐഓᄽࠔၨ࠶૙Ǘेٷᄱ೗ ࠔၨ॔࠶૰܈ă DŽ2013-07-08Dž ৎනLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆቻਸ କኝዎྵ݆࠽ߢ߾ፕፗ༌ࣷLjࣷฉཚԒLjপ ዁ৃ౎5ሆڹLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ ॺ૬ڦ࠽ߢ֪॔ဣཥᅙঢ়ޮ߃ඇࡔں๨पᅜ ฉڦۉ๫໼Ă࠽խۉ໼ࢅԒ਽ৎ3000ᇆॆLj ݀၄ྵ݆࠽ߢࠌऺ90ྤܠཉْă 2012౎Ljࡔॆ๋೗ᄱ೗॔۽࠶૙ևோ ሞᅙᆶ5ู߲ਸቛ๬ۅ߾ፕڦएإฉLjॺ૬ କޮ߃ඇࡔں๨पᅜฉ࠽խĂۉ๫ĂԒኽ ௃༹ڦ࠽ߢ֪॔ဣཥăణമLjඇࡔ31ู߲ ࢅ281߲ں๨प๋೗ᄱ೗॔۽࠶૙ਆᅙঢ়Ӏ ᄲ൱त้ک୤֪॔ဣཥ৊ႜ֡ፕLjܔ֪॔ ڟڦჹዘྵ݆࠽ߢ৊ႜت૙ă DŽ2013-07-08Dž In 2009, the former SFDA issued the "Notice on Effectively Strengthening the Sales Management of the Part Containing Special Drugs Compound Formulations" (GSYJA [2009] No. 503), which raised r e q u i r e m e n t s f o r t h e m a n a g e m e n t o f p u r c h a s i n g a n d d i s t r i b u t i o n o f compound code ine -con ta in ing o ra l solutions, compound liquorice tablets and d iphenoxyla te t ab le t s , and has played a positive role in suppressing the loss and abuse of such drugs from medicinal sources. To further strengthen Recently, CFDA held a working conference on remediation of illegal advertisements, which briefed that, by the end of May this year, the CFDA advertising monitoring system has covered more than 3,000 television and radio stations, newspapers at prefecture-level and above, and detected a total of more than 900,000 i l legal advertisements. In 2012, CFDA has established, on the basis of previous pilot efforts in five provinces of China, an advert is ing monitoring system with coverage of all television and radio stations, newspapers at prefecture- the management of the purchasing and distribution of the above drugs to protect public health, on July 8, 2013, CFDA General Office issued a Notice requiring a l l F o o d a n d D r u g A d m i n i s t r a t i o n (Drug Administration) departments of all provinces, autonomous regions and municipalities to continue and promote this work, strengthen drug manufacturers sales management; strictly regulate drug distributors management for purchase and marketing; and intensify the supervision RYHU�WKHVH�¿HOGV�� (2013-07-08) level and above. At present, 31 provincial and 281 prefecture-level Food and Drug Administration departments have regular operations of the monitoring systems as required to cope with the monitored serious illegal advertisements. (2013-07-08) Volume VI 2013 3 ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ Ӹࠅཐ݀քĖ࠲ᇀჹ߭ዐᄱᆃೌ ಜ዆ࡀݔतዐᄱದݛ੓૭๬ۅ ჺ৯࠶૙ڪᆶ࠲๚ᅓڦཚኪė ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ݀ քĖ࠲ᇀ࠻ןํแႎႪ۩<ᄱ೗ ঢ়ᆐዊଉ࠶૙ࡀݔ>ڦཚኪė CFDA General Office Issued the "Notice on Stringent Management of Chinese herbal sliced medicine Processing Standards, TCM Formulated Granules Pilot Study and Other Related Issues" CFDA Issued the "Notice on Implementing the Newly Revised Good Supply Practice for Pharmaceutical Products (GSP)" ߵ਍Ėዐࣀට௷ࠌࢅࡔᄱ೗࠶૙݆ė ڦࡀۨLjู߳प๋೗ᄱ೗॔۽࠶૙ևோ၎ ीܔูपዐᄱᆃೌಜ዆ࡀݔ৊ႜକႪ۩Lj ܔࡀݔዐᄱᆃೌಜ዆Lj༵ߛዐᄱᆃೌዊଉ ࣩ݀କओटፕᆩăڍᄺ؜၄କॽชتሞ੔ ჺ঩܎ڦ੔ჺׂ೗ईӀ዆व࠶૙ڦׂ೗ଚ ෇ಜ዆ࡀݔڪ࿚༶Ljྺჹ߭࠶૙Lj2013౎6 ሆ26නLjࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ݀ք ཚኪLjᄲ൱ู߳प๋೗ᄱ೗॔۽࠶૙ևோ ᄲჹ߭ዐᄱᆃೌಜ዆ࡀݔĂჹ߭ዐᄱದݛ ੓૭๬ۅჺ৯࠶૙ࢅჹ߭ᄱ೗ጀ֩อೠอ ಼ă DŽ2013-06-26Dž ႎႪ۩ڦĖᄱ೗ঢ়ᆐዊଉ࠶૙ࡀݔė DŽᅜူ०׬ᄱ೗GSPDžᅙ݀քแႜăߵ਍ Ėዐࣀට௷ࠌࢅࡔᄱ೗࠶૙݆ėᆶ࠲ࡀۨ ࢅĖࡔॆᄱ೗ҾඇĐๆܾ࿵đࡀࣄėڦ ጺ༹ᄲ൱Ljࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆᇀ 2013౎6ሆ24න݀քཚኪLjᄲ൱ሞ2015౎౎ ڹമྜׯႎႪ۩ᄱ೗GSPڦํแ߾ፕă ཚኪᄲ൱Lj߳प๋೗ᄱ೗॔࠶ևோခ Ղ؊ݴණ๎࠻ןํแႎႪ۩ᄱ೗GSPڦዘ ᄲႠࢅ৆೨ႠLjൎํेഽፇኯଶڞĂ௽ඓ ߾ፕሴඪĂ஌ํํแݛӄLjླྀ৊߾ፕᆶႾ ਸቛăᄲेഽֱۙჺ৯Ljఄൣါ൶ాᄱ೗ ঢ়ᆐഓᄽ၄ጒत࿚༶LjᆶኍܔႠں֑ൽٯ แLjٝ৊ഓᄽӀቷႎႪ۩ᄱ೗GSPᄲ൱৊ ႜ߀ሰLjሞࡀ้ۨ၌ాྜׯํแ߾ፕă ཚኪ௽ඓLjߵ਍ĖࡔခᇾӸࠅཐ࠲ ᇀᆇ݀ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆዷᄲኰ ሴాยऐࠓࢅටᇵՊ዆ࡀۨڦཚኪėDŽࡔ Ӹ݀Ē2013ē24ࡽDžڦᄲ൱Ljᄱ೗ঢ়ᆐႜ አႹ੗ᇑᄱ೗ঢ়ᆐዊଉ࠶૙ࡀݔණኤଇၜ ႜአႹ੗ॽደօኝࢇྺᅃၜႜአႹ੗ăٗ ၄ሞഐLjᄱ೗ঢ়ᆐഓᄽڦĖᄱ೗ঢ়ᆐႹ੗ ኤėईĖᄱ೗ঢ়ᆐዊଉ࠶૙ࡀݔණኤኤ ກėඪࢆᅃኤڟ೺ڦLj਩ᅜႎႪ۩ᄱ೗ GSPྺՔጚLjܔ಼݀ഓᄽĂଭ๳ഓᄽፇኯ As per the provis ions of the "Drug Adminis t ra t ion Law of the People’s Republic of China", all provincial food and drug administration departments have revised the Provincial processing standards of Chinese herbal sliced medicine to ensure standardized processing and quality improvement effectively in succession. But problems still crop out in this respect, such as the overinclusion of products under 5 '�RU�SURGXFWV�FODVVL¿HG�DV�SUHSDUDWLRQV� T h e n e w l y r e v i s e d " G o o d S u p p l y Practice for Pharmaceutical Products" (hereinafter referred to as Drug GSP) has been promulgated for implementation. In accordance with the relevant provisions of Drug Adminis t ra t ion Law of the People’s Republic of China and the overall requirements under the Twelfth Five-Year Plan for National Drug Safety, CFDA issued a Notice on June 24, 2013 requiring that the implementation of the newly revised GUXJ�*63�VKDOO�EH�¿QLVKHG�EHIRUH�WKH�HQG�RI� 2015. The Notice requires that food and drug administration departments at all levels must fully understand the importance and urgency of the new GSP, effectively strengthen the organization and leadership, and clarify work duties and implementation programs to promote the work to be done in order. Investigation and research shall be reinforced to find out the situation and problems of the drug supply enterprises within each area, to take targeted measures to promote enterprise restructuring in accordance with the requirements of the new into the processing standards management, in order to reinforce administration in this area, on June 26, 2013, China Food and Drug Administration (CFDA) issued a Notice requiring all provincial food and drug administration departments to strictly regulate the processing standards of Chinese herbal sliced medicine, TCM formulated granules pilot study, and the corresponding drug registration review and approval. (2013-06-26) GSP and ensure due implementation within the time limit. The Notice clarifies that, according to the �1RWLFH�RI� WKH�*HQHUDO�2I¿FH�RI� WKH�6WDWH� Council on the Printing and Distribution of the Provisions on the Primary Duties, ,QWHUQDO�$JHQF\�DQG�6WDI¿QJ�RI� WKH�&KLQD� Food and Drug Administration" (GFB [2013] No. 24), drug supply administrative authorization and drug GSP Certification shall be gradually integrated into one administrative authorization. From now on, drug administration departments shall organize new GSP-based inspections on drug wholesalers or retailers if either of the "Drug Supply Certificate" or "Drug GSP &HUWL¿FDWH��H[SLUHV��ZKLFK�VKDOO�EH�UHQHZHG� 4 CHINA PHARMACEUTICAL NEWSLETTER ॠֱLjޙࢇᄲ൱ڦLj࣑݀Ėᄱ೗ঢ়ᆐႹ੗ ኤėLjժ݀ݣĖᄱ೗ঢ়ᆐዊଉ࠶૙ࡀݔණ ኤኤກėă2013౎12ሆ31නമLjኤກڟ೺ ڍ࿮݆ྜׯ߀ሰڦLj੗ᅜᅈฤ൩Ljܔኤກ ᆶၳ೺ߴᇎփגࡗ2014౎6ሆ30නڦჽჄă ཚኪ༵؜LjྺओटĂ࿘ྉںླྀ৊ႎႪ ۩ᄱ೗GSPڦ࠻ןํแLj߳ںᆌړ঳ࢇଇ ၜႹ੗ڦኝࢇ߾ፕժӀቷᅜူ้၌ᄲ൱Lj ዆ۨਏ༹߾ፕݛӄLjݴօํแă DŽᅃDžጲ2013౎7ሆ1නഐLjႎਸӸᄱ ೗ঢ়ᆐഓᄽLjᅜतᄱ೗ঢ়ᆐഓᄽฤ൩ႎॺ DŽ߀ĂકॺDžᆐᄽׇ໯ࢅ֞ੰᆌړޙࢇႎ Ⴊ۩ᄱ೗GSPڦᄲ൱, ޙࢇཉॲڦ݀ݣĖᄱ ೗ঢ়ᆐႹ੗ኤėࢅĖᄱ೗ঢ়ᆐዊଉ࠶૙ࡀ ݔණኤኤກėă DŽܾDž2014౎12ሆ31නമLjঢ়ᆐᅧ௭Ă ஑ፋᄱ೗ࢅ৛หᄱ೗ᅜतڒӣཞࣅ዆वࢅ ᩺ૌघ໎ڦ಼݀ഓᄽĂঢ়಼ጚ੗ᅜথ๴ᄱ ೗྿ྂئ٪ದໃڦ಼݀ഓᄽLjᆌړޙࢇႎ Ⴊ۩ᄱ೗GSPᄲ൱Ljޙࢇཉॲڦ࣑݀Ėᄱ ೗ঢ়ᆐႹ੗ኤėࢅĖᄱ೗ঢ়ᆐዊଉ࠶૙ࡀ ݔණኤኤກėǗփޙࢇཉॲڦLjࢃ३ഄ၎ ᆌঢ়ᆐݔྷईൽၩഄԥ྿ྂጨ߭ă DŽෙDž2015౎12ሆ31නമLj໯ᆶᄱ೗ঢ় ᆐഓᄽ࿮ஃഄĖᄱ೗ঢ়ᆐႹ੗ኤėࢅĖᄱ ೗ঢ়ᆐዊଉ࠶૙ࡀݔණኤኤກė๟ޏڟ ೺LjՂႷٳڟႎႪ۩ᄱ೗GSPڦᄲ൱ăጲ 2016౎1ሆ1නഐLj࿄ٳڟႎႪ۩ᄱ೗GSPᄲ ൱ڦLjփڥीჄٗ๚ᄱ೗ঢ়ᆐऄۯă ཚኪഽۙLjู प๋೗ᄱ೗॔࠶ևோᄲӝ ႎႪ۩ᄱ೗GSP࠻ןํแ߾ፕፕྺړമࢅৃ ࢫᅃ้߲೺॔࠶߾ፕڦᅃၜዘۅඪခઠጃLj Ӧฉዘᄲ࿋ዃLjଚ෇ᅱ๚නײăᄲჹ߭ኴႜ ՔጚLjᅈ݆ਸቛණኤࢅॠֱ߾ፕLjܔఫၵঢ়ᆐ ཉॲֶLj࠶૙փࡀݔLjඡ୺๨ׇወႾڦᄱ೗ঢ় ᆐഓᄽLjᄲॕਦൣཽ؜๨ׇăDŽ2013-06-25Dž simultaneously if the enterprise met the requirements. Validity prolongation can be granted upon application for certificates overdue before December 31, 2013, but the prolongation should be no later than June 30, 2014. The Notice points out that, in order to actively and steadily push forward the implementation of the New GSP, all areas should, according to the requirements of the integration of the two licenses and the following time limits, develop specific work programs for step-by-step implementation. (1) From July 1, 2013, all new start-up drug distributors, as well as their newly applicat ion for building (renovating o r e x p a n d i n g ) b u s i n e s s p r e m i s e s and warehouses shall conform to the requirements of the new GSP. "Drug Supply &HUWL¿FDWH��DQG��'UXJ�*63�&HUWL¿FDWH��VKDOO� EH�LVVXHG�RQO\�WR�TXDOL¿HG�HQWHUSULVHV� (2 ) Before December 31 , 2014 , a l l wholesalers distributing vaccines, narcotic drugs, psychotropic substances, anabolic agents and peptide hormones, as well as wholesalers approved for commissioned storage and distribution shall comply with the new GSP requirements, with renewal of �'UXJ�6XSSO\�&HUWL¿FDWH��DQG��'UXJ�*63� Certificate" only for qualified enterprises; as for unqual i f ied enterpr ises , their corresponding business scope should be UHGXFHG��RU� WKHLU�FRPPLVVLRQ�TXDOL¿FDWLRQ� should be canceled. (3) Before December 31, 2015, all drug distributors must meet the requirements of the new GSP, regardless of the expiry date RI�WKH��'UXJ�6XSSO\�&HUWL¿FDWH��DQG��'UXJ� GSP Certificate". Since January 1, 2016, enterprises that fail to meet the requirements of the new GSP drug must not continue their drug distribution activities. The Notice stressed that the provincial food and drug administration departments should take the implementation of the new GSP as a priority in current and future administration, put it on an important position and on the agenda. They should strictly enforce the standards, carry out certification and inspection according to the law, and resolutely remove those drug distributing enterprises with substandard operating conditions and bad management that disturbing the market order out of the market. (2013-06-25) ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ ᄱ࿿ଣض๬ᄓऐࠓጨ߭ණۨ ࠅߢDŽڼ1ࡽDž݀ք CFDA Issued the Announcement for Accreditation of Drug Clinical Trial Institutions (No. 1) 2013౎5ሆ27නLjࡔॆ๋೗ᄱ೗॔۽࠶ ૙ጺਆ݀քକᄱ࿿ଣض๬ᄓऐࠓጨ߭ණۨ ࠅߢDŽڼ1ࡽDžăߵ਍Ėዐࣀට௷ࠌࢅࡔᄱ ೗࠶૙݆ėࢅĖᄱ࿿ଣض๬ᄓऐࠓጨ߭ණ ۨӸ݆DŽ๬ႜDžėLjঢ়ጨଙอֱࢅ၄ׇॠ ֱLjණۨԛ৙ٷბڼᅃᅅᇾڪ16ॆᅅଐऐ ࠓਏᆶᄱ࿿ଣض๬ᄓऐࠓጨ߭Lj݀ߴĖᄱ ࿿ଣض๬ᄓऐࠓጨ߭ණۨኤກėă On May 27, 2013, CFDA issued the Announcement for Accredi ta t ion of Drug Clinical Trial Institutions (No. 1). According to the "Drug Administration Law of the People's Republic of China" and the "Provisions for Accreditation of Drug Clinical Trial Institutions (Interim)", after the data review and site inspection, CFDA has accredited 16 medical institutions including Peking University First Hospital as eligible for drug clinical trials, and the �$FFUHGLWDWLRQ�&HUWL¿FDWH�IRU�'UXJ�&OLQLFDO� Trial Institutions" have been issued to these 16 institutions. Volume VI 2013 5 Quali¿ed medical institutions for drug clinical trials and accredited specialties ਏԢᄱ࿿ଣض๬ᄓऐࠓጨ߭ڦᅅଐऐࠓतණۨጆᄽ Location of Medical institutions ᅅଐऐࠓ໯ሞں Name of medical institution ᅅଐऐࠓఁ׬ Accredited specialties ණۨጆᄽ Certi¿cate No. ኤກՊࡽ Beijing ԛ৙๨ Peking University First Hospital ԛ৙ٷბڼᅃᅅბᇾ Immunization, pediatric intensive care medicine, medical imaging (cure), Orthopedics ௨ᅧĂၭܹዘኢᅅბĂᅅბᆖၟDŽዎଐDžĂࠡ੔ 417 Jiangxi Province ॿဇู Pingxiang City People's Hospital ೜ၕ๨ට௷ᅅᇾ Respiratory, digestive, neurology, cardiovascular, endocrine, immune and tumor ࢬဌĂၩࣅĂหঢ়ా੔Ă႐ე࠶Ăాݴ௠Ă௨ᅧĂ዗ୀ 418 Yunnan Province ሊళู First Af¿liated Hospital of Kunming Medical College ઑ௽ᅅბᇾڼᅃ޹ຌᅅᇾ Tumors, endocrine, Rheumatology, ENT, blood ዗ୀĂాݴ௠Ăޅโ௨ᅧĂܺԱࢥĂეᅂ 419 Jiangsu Province ॿู໋ Nantong Cancer Hospital ళཚ๨዗ୀᅅᇾ Tumor ዗ୀ 420 Anhui Province Ҿู࣫ Second Af¿liated Hospital of Anhui Medical University Ҿ࣫ᅅ੔ٷბڼܾ޹ຌᅅᇾ Cancer, kidney disease, infection, respiratory ዗ୀĂหբĂدටĂࢬဌ 421 Jiangxi Province ॿဇู Jiangxi Cancer Hospital (Second People's Hospital of Jiangxi Province) ॿဇู዗ୀᅅᇾ DŽॿဇูڼܾට௷ᅅᇾDž Blood, orthopedics, gynecology, oncology, medical imaging (radiation therapy, nuclear medicine), TCM oncology ეᅂĂࠡ੔Ă޺੔Ă዗ୀĂ ᅅბᆖၟDŽݣพዎଐĂࢃᅅბDžĂዐᅅ዗ୀ 422 Beijing ԛ৙๨ Dongzhimen Hospital, Beijing University of Chinese Medicine ԛ৙ዐᅅᄱٷბ۫኱ோᅅᇾ TCM Cardiovascular medicine, TCM neurology, TCM respiratory medicine, TCM Digestive medicine, TCM kidney Diseases, TCM gynecology, TCM pediatric medicine, endocrine (breast), TCM surgery, infection, TCM Geriatric medicine, TCM endocrine, TCM oncology, TCM anorectal medicine, TCM peripheral vascular medicine, TCM skin medicine, TCM Orthopedic medicine, TCM ENT, TCM ophthalmology ዐᅅ႐ე࠶Ăዐᅅหঢ়ా੔ĂዐᅅࢬဌĂዐᅅၩࣅĂዐᅅะթĂዐᅅ޺੔Ăዐᅅ ܹ੔Ăాݴ௠DŽළ၇DžĂዐᅅྔ੔ĂߌකĂዐᅅ઻౎թĂዐᅅాݴ௠Ăዐᅅ዗ ୀĂዐᅅߔ׌Ăዐᅅዜྷე࠶ĂዐᅅೄޒĂዐᅅࠡ੔ĂዐᅅܺԱࢥĂዐᅅᄅ੔ 423 Guangdong Province ࠽ู۫ Cancer Center of Guangzhou Medical University ࠽ዝᅅბᇾ޹ຌ዗ୀᅅᇾ Tumor ዗ୀ 424 Henan Province ࢋళู Henan Tumor Hospital ࢋళู዗ୀᅅᇾ Blood, tumor ეᅂĂ዗ୀ 425 Xinjiang Uygur Autonomous Region ႎঀྼ࿱ܻጲዎ൶ People's Hospital of Xinjiang Uygur Autonomous Region ႎঀྼ࿱ܻጲዎ൶ට௷ᅅᇾ cardiovascular (Hypertension), immune, digestive, skin, oncology, endocrine ႐ე࠶DŽߛეუDžĂ௨ᅧĂၩࣅĂೄޒĂ዗ୀĂాݴ௠ 426 Hubei Province ࢶԛู Zhongshan Hospital of Hubei Province ࢶԛูዐ෷ᅅᇾ Infection, neurology, digestive ߌකĂหঢ়ా੔Ăၩࣅ 427 Shandong Province ෷ู۫ Af¿liated Hospital of Binzhou Medical College ՟ዝᅅბᇾ޹ຌᅅᇾ Respiratory, digestive, endocrine, oncology,general surgery (gastrointestinal) ࢬဌĂၩࣅĂాݴ௠Ă዗ୀĂ೵ཚྔ੔DŽ࿈׌Dž 428 Zhejiang Province ኅॿู Zhejiang Hospital ኅॿᅅᇾ Intensive care medicine, respiratory, geriatric (elderly cardiovascular, urinary elderly, senile endocrinology) ዘኢᅅბĂࢬဌĂ ઻౎թDŽ઻౎႐సე࠶Ă઻౎௠ౖĂ઻౎ాݴ௠Dž 429 Shanghai ฉ࡛๨ Xinhua Hospital Af¿liated to Shanghai Jiao Tong University School of Medicine ฉ࡛঍ཚٷბᅅბᇾ޹ຌႎࣀᅅᇾ Cardiovascular, respiratory, ophthalmology, otolaryngology, endocrine, digestive, hematology, urinary, pediatric hematology, pediatric kidney disease, pediatric endocrinology, pediatric neurology, Pediatric Cardiology, ultrasound diagnosis ႐ე࠶ĂࢬဌĂᄅ੔ĂܺԱჴࢥĂాݴ௠ĂၩࣅĂეᅂĂ௠ౖĂၭܹეᅂĂၭܹ ะթĂၭܹాݴ௠Ăၭܹหঢ়թბĂၭܹ႐ሤթĂגำኑ܏ 430 Guangdong Province ࠽ู۫ Shenzhen Second People's Hospital ศᒰ๨ڼܾට௷ᅅᇾ Blood, endocrine, nephrology, respiratory, orthopedics, Neurosurgery, urology, general surgery (thyroid and breast, liver and gallbladder), burns, chest surgery, integrative medicine, intensive care medicine ეᅂĂాݴ௠ĂะթბĂࢬဌĂࠡ੔Ăหঢ়ྔ੔Ă௠ౖĂ ೵ཚྔ੔DŽोළĂߊڊDžĂฏฅ੔ĂႤྔ੔Ă ዐဇᅅ঳ࢇĂዘኢᅅბ 431 Jilin Province ञଠู Second Hospital of Jilin University ञଠٷბڼܾᅅᇾ Digestive, neurology, blood, cancer, ophthalmology, General Surgery ၩࣅĂหঢ়ా੔ĂეᅂĂ዗ୀĂᄅ੔Ă೵ཚྔ੔ 432 DŽ2013-05-27Dž 6 CHINA PHARMACEUTICAL NEWSLETTER ࡔॆ๋೗ᄱ೗॔۽࠶૙ጺਆ݀ք ܔ2012౎ӲĖࡔॆएԨᄱ࿿ణ ୤ėᄱ೗ํแۉጱ॔࠶ڦࠅߢ CFDA Issued Announcement on Implementation of Electronic Supervision for Drugs in the "National Essential Drug List" (2012 Edition) 2013౎5ሆ9නLjࡔॆ๋೗ᄱ೗॔۽ ࠶૙ጺਆ݀քĖ࠲ᇀ2012౎ӲĖࡔॆए Ԩᄱ࿿ణ୤ėᄱ೗ۉጱ॔࠶ํแ߾ፕڦࠅ ߢėDŽ2013౎ڼ10ࡽDžLjᄲ൱ᄱ೗ิׂഓ ᄽݐิׂ2012౎ӲĖࡔॆएԨᄱ࿿ణ୤ė ᄱ೗೗ዖLj࿮ஃ๟ޏ֖ᇑएԨᄱ࿿ቲՔ֑ ࠔLj਩ᆌӀࡀۨํแۉጱ॔࠶ăࡔׂᄱ೗ ࢅሞࡔాݴԈጎڦ৊੨ᄱ೗ᆌᇀ2013౎11 ሆڹമํႜۉጱ॔࠶Lj৊੨ᄱ೗ᆌᇀ2014 ౎3ሆڹമํႜۉጱ॔࠶ăࠅߢᄲ൱၎࠲ ิׂഓᄽࢅ৊੨ᄱ೗ৣྔ዆ᄱ׍ฆᆌӀቷ ᇱࡔॆ๋೗ᄱ೗॔۽࠶૙ਆĖ࠲ᇀ৊੨ᄱ ೗ํแۉጱ॔࠶ᆶ࠲๚ᅓڦཚኪėDŽࡔ๋ ᄱ॔ҾĒ2013ē23ࡽDžĂĖ࠲ᇀᆇ݀ᄱ೗ ۉጱ॔࠶߾ፕኸڞᅪ९ڦཚኪėDŽࡔ๋ᄱ ॔ӸĒ2010ē283ࡽDžࢅĖ࠲ᇀፔࡻ2012 ౎܈ᄱ೗ۉጱ॔࠶߾ፕڦཚኪėDŽ๋ᄱ॔ ӸǷ2012ǹ85ࡽDžڦᄲ൱Ljओटਸቛ၎࠲ ߾ፕLjඓԍࡔॆएԨᄱ࿿ۉጱ॔࠶Ӏ೺ํ ႜă DŽ2013-05-17Dž On May 9 , 2013 , CFDA i s sued the Announcement on Implementation of Electronic Supervision for Drugs in the 2012 Edition "National Essential Drug List" (2013 No. 10), requiring all of those drug manufacturers producing drugs enlisted in the 2012 edition of "National Essential Drug List", should implement e lec t ron ic superv i s ion as r equ i red . Regardless they are involved in bidding and purchasing of essential drugs, the electronic supervision for domestically produced drugs and domestically sub- packaged imported drugs should be carr ied out no la ter than November 2013, and the electronic supervision for imported drugs should be carried out no later than March 2014. The Announ