CHINA PHARMACEUTICAL NEWSLETTER

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1 Volume VII 2012 CHINA PHARMACEUTICAL NEWSLETTER The Fourth Inter-ministerial Coordination Joint Meeting on Combating the Production and Sales of Counterfeit Drugs convened On June 15, 2012, the Fourth Interministerial Coordination Joint Meeting on Combating the Production and Sales of Counterfeit Drugs was held in Beijing. General convener of the Meeting, Health Minister Chen Zhu chaired the meeting and made concluding remarks. Convener of the Meeting, SFDA Commissioner Yin Li reported the work situation of the fight against counterfeit drugs in recent years. At the meeting, the representatives of the Joint Meeting member units discussed and analyzed the status quo and existing problems of the fight against counterfeit drugs, and studied the work priorities in the next step. The representatives of the Joint Meeting member units also held in-depth discussions on how to increase efforts to crack down on internet advertising and sales of counterfeit drugs, and severely investigate and deal with cases of illegal sales of drugs via consigning and delivery channels. (June 15, 2012) National Essential Drug Sampling Inspection Work Forum held in Xining 2012 To implement the policies of Deepening the Reform of Medical and Healthcare System, and the essential drug system, from June 19 to 20, 2012, SFDA Bureau of Investigation & Enforcement held the 2012 National Essential Drug Sampling Inspection Work Forum in Xining, Qinghai Province. The Food and Drug Administration Departments of the provinces (autonomous regions, municipalities) reported the progress of the sampling inspection on essential drugs at the Forum, and made in-depth study and discussion of the problems encountered in sampling inspection, relevant trainings were conducted on the management and use of essential drug sampling inspection information system. (June 25, 2012) National Food and Drug Complaints & Reports Work Forum held in Gansu From June 11 to , the SFDA held the 2012 National Food and Drug Complaints & Reports Work Forum in Gansu. The Forum summarized the work of national food and drug complaints & reports in the previous period, analyzed the new situation therein, studied and planned the work tasks in the next stage. SFDA Deputy Commissioner Published by China Center for Pharmaceutical International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

2 Bian Zhenjia attended the meeting and delivered a speech. The attendees of the Forum are the leaders in charge of the food and drug administration departments and Complaints & Reports institutions of all provinces (autonomous regions and municipalities), Xinjiang Production and Construction Corps, and the Health Department of GLD General Logistics Department of PLA, as well as the leaders and relevant personnel of SFDA Departments and Bureaus, and SFDA (June 13, 2012) SFDA revised the package inserts for hydrochloride lamotrigine oral preparation and misoprostol oral preparation To control the risk of drug use, on May 18, 2012, the SFDA revised the package inserts for hydrochloride lamotrigine oral preparation and misoprostol oral preparation according to the results of adverse reaction evaluation. Meanwhile, SFDA requires food and drug administration departments of all provinces (autonomous regions and municipalities) to notify the pharmaceutical manufacturers within their respective administrative areas to revise the package inserts and labels as soon as possible, and notify the revisions to relevant medical institutions, pharmaceutical distributors and other units. Related pharmaceutical manufacturers should also take the initiative to track the safety of clinical application of such products, to collect and report adverse reaction delete as required in a timely manner. (June 8, 2012) SFDA Solicits Public Comment on the Relevant Provisions on Strengthening the Supervision and Management of Pharmaceutical Excipients On June 4, 2012, the SFDA issued the Relevant Provisions on Strengthening the Supervision and Management of Pharmaceutical Excipients (Draft for Comment)" (hereinafter referred to as the Draft ), to solicit public comments. Pharmaceutical excipients refer to excipients and additives used in the production and dispensing of drugs, which are important constituents that directly affect drug quality and safety. To further strengthen the supervision of the production and use of pharmaceutical excipients, ensure drug quality and safety, the SFDA developed the Draft in accordance with relevant laws and regulations. According to the Draft, the SFDA will take the following measures to further reinforce the management of the production and use of pharmaceutical excipients. First, through further implementation of the responsibility of pharmaceutical manufacturing enterprises, to promote their conscientious audit and management on pharmaceutical excipients manufacturers and their products; second, through further implementation of the responsibilities of regulatory departments, to achieve an extensive regulation on pharmaceutical excipients manufacturers; GMP 2 CHINA PHARMACEUTICAL NEWSLETTER

3 third, through the implementation of GMP, categorized management and the associated review of pharmaceutical preparations, to improve the access threshold for pharmaceutical excipients; fourth, through reinforced punishment measures, to deter illegal behaviors, and guide pharmaceutical preparation manufacturers and pharmaceutical excipients manufacturers to regulate their production and use. The Draft makes it clear that the pharmaceutical preparations manufacturers are the responsible entity for the quality of drugs, which shall put strict control on the excipients used for pharmaceutical production, and conduct audit on suppliers. The purchased pharmaceutical excipients can be used in the production only after tested as qualified. The "Draft" stressed that the manufacturers of pharmaceutical preparations shall manufacture products abiding by formula, manufacturing process, the changes of which, if any, should be subject to research and variation procedures in accordance with relevant provisions. The Draft clarifies the regulatory responsibilities of drug administration departments at all levels on manufacturers of pharmaceutical preparations and excipients, it requires drug administration departments at all levels to take drug manufacturers as the regulatory priority, and conduct extensive inspections on excipients manufacturers based on the inspection results on pharmaceutical preparations manufacturers, so as to incorporate the production and application of pharmaceutical excipients into the scope of regulation, to realize the whole process supervision on pharmaceutical production and supply chain. The Draft conducts the management of pharmaceutical excipients in reference to that of pharmaceutical APIs, in this way the regulation is reinforced: first, the pharmaceutical excipients manufacturers should organize production in accordance with the "GMP for Pharmaceutical Excipients", the access threshold for production enterprises is raised; second, conduct categorized management on excipients according to risk levels, implement strict access system on high-risk excipients and manufacturers, to strengthen risk control; third, new pharmaceutical excipients must be reviewed in association with pharmaceutical preparations, this highlights the pharmaceutical manufacturers responsibility of inspection and audit on new excipients, and further regulates the accountable resources and technical requirements for pharmaceutical excipients; fourth, the current work priority, which aims to enhance and improve the standard of pharmaceutical excipients, is conducive to the further enhancement of the quality of pharmaceutical preparations. The deadline for public comments is June 8, ( ) SFDA Opens Sina Weibo Account On June 1, 2012, the SFDA opened the official Sina Weibo entitled as "China's Drug Administration. Through this platform, SFDA shall introduce relevant policies on food and drug administration, release the quality, safety and early warning information for drugs, health foods, cosmetics, medical devices, and catering industry, and address food and drug safety issues of public concern. Sina Weibo: 7?topnav=1&wvr=3.6&topsug=1 ( ) ?topnav=1&wvr=3.6&topsug= Volume VII

4 SFDA Requires to Further Strengthen the Regulation on Compound Preparations Containing Ephedrine On May 31, 2012, the SFDA issued a circular on requiring relevant parties to earnestly implement applicable national laws and regulations on the management and control of special pharmaceuticals and preparations containing Ephedrine. The Circular informs that, recently, there have been case reports that lawbreakers in Jiangsu, Zhejiang, Shandong and other places fraudulently purchase Contac NT and other compound preparations containing ephedrine from pharmaceutical retailers, providing opportunities for drug dealers criminal activities. The Circular stresses that, food and drug administration departments at all levels must attach great importance to this end, and conscientiously implement relevant national laws, regulations and policy requirements on the management and control of special drugs and ephedrinecontaining preparations, to draw lessons from the cases, as well as inferences about other cases, to take active measures for strict supervision on pharmaceutical manufacturers and distributors within local areas, strictly control the production and distribution of ephedrine-containing preparations, and investigate and crack down severely on illegal activities in the purchase and sale of ephedrine-containing preparations. ( ) Q & A SFDA Center for Drug Evaluation Replies Questions on the Practical Aspects of the Notice on Data Submission for Chemical IND Applying for Pharmaceutical Research IND The Notice on Data Submission for Chemical IND Applying for Pharmaceutical Research, issued by SFDA Center for Drug Evaluation (CDE) on May 10, 2012, has attracted wide attention within the industry, and elicited many questions on the practical operations from the applicants, the answers as follows: 1Q. What is the relationship between Annual Report of Pharmaceutical Research and the Supplementary Application? If there is any change in this year's production process, and a detailed description in the Pharmaceutical Research Annual Report is provided, is the supplementary application still necessary to submit? A: As one of its purposes, the implementation of the Pharmaceutical Research annual reporting system is to reduce the supplementary application for changes in the R & D process of innovative drugs. At present, China's registration regulations and guidelines have not established corresponding management and technical requirements for changes in the R & D process of innovative drugs. From the perspective of technical review, the applicants are recommended to firstly conduct research and evaluation on the changes. A supplementary application the quality, safety or bioavailability IND 1. 4 CHINA PHARMACEUTICAL NEWSLETTER

5 of drugs shall be submitted. While the research data for other minor changes can be submitted in the Annual Reporting System. All changed issues and research data should be included in the annual report, regardless of whether or not to submit the supplementary application. 2Q. Article IV of the Notice on Data Submission for Chemical IND Applying for Pharmaceutical Research states that the applications for Multiregional Clinical Trial (MRCT) shall be handled with reference to this Notice, the question is: whether only Phase I, and II of MRCT application shall be handled with reference to this Notice, or all MRCT applications need to be implemented with reference to this Notice, to submit information summary table of the Pharmaceutical Research? A: The Phase I, and II of MRCT applications that have been included in the IND channel of CDE review task management system shall be handled with reference to this Notice, and shall submit information summary table of the Pharmaceutical Research in the format as required in the Attachment of the Notice. Since the annual report system is still in the exploratory stage, it is not mandatory to submit its pharmaceutical research information summary for Phase III MRCT. But in order to improve the efficiency of the review, CDE strongly recommends that the applicants refer to the format attached in the Notice to submit the pharmaceutical research information summary. Taking into account the abundant pharmaceutical research information in Phase III clinical application, the submitted information should not be limited to the items listed in the summary table. 3Q. The Notice states that Once the innovative drug is first approved for clinical research, the applicant should, from the date of approval, submit on annual basis the Annual Report of Pharmaceutical Research for Chemical IND Application of chemical drugs. Can it be understood that, the annual report should be submitted within a calendar year as from the date of approval? For clinical applications recently approved (less than 1 year), will they have to submit the annual report before August 30, 2012? Or for those approved before August 30, 2011 should submit annual report prior to August 30 every year? Will the projects approved after Aug. 30, 2012 submit the annual report within a calendar year as from the date of approval? A: For all drug varieties that have been approved before May 10, 2012 for clinical study, in addition to the circumstances described in Question 4, annual reports shall be submitted before August 30, If there are no updates or changes in the research information compared to latest submitted application information, the annual report would suffice to mark "no updates or changes since xxxx (year) xx (month) to xxxx (year) xx (month)". Thereafter, the follow-up annual reports shall be submitted on a yearly basis as from the date of the As for drug varieties obtained the 2. IND Phase Phase IND Phase Phase Phase Phase 3. IND xxxx xx xxxx xx Volume VII

6 approved for clinical study after May 10, 2012, the first annual report shall be submitted within a calendar year as from the date of approval. Thereafter, the follow-up annual reports shall be submitted in every calendar year as from the date of the submission of the 4Q. When will the submission of the annual report of Pharmaceutical Research come to an end? If a drug has almost completed Phase III clinical study or is preparing to apply for NDA, will it still need to submit an annual report? A: The submission of Pharmaceutical Research annual report shall not stop until the drug applies for NDA or the R&D no longer conduct in China. For drug varieties that have entered into pivotal phase III clinical studies and planned to submit NDA application within a short-term (e.g. one year), the applicant can decide under the circumstances to submit the Pharmaceutical Research annual report or not. 5Q. Can the pharmaceutical annual reports of multiple clinical studies of the same product of a company be shared? Multiple regional clinical trials (MRCT) might be conducted on the same drug or maybe there are new indications; after obtaining the approval for clinical trials, can an enterprise submit only one annual report for the same product, indicating in the report all acceptance numbers of the clinical trials involved, so that different acceptance documents of the drug may link to the report? A: In the case of the same product (with identical formulation, strength, formula, process and other pharmaceutical information), this is 6Q. If several MRCTs are in progress, and one of which has submitted NDA in China (including the latest pharmaceutical information), or has been approved of NDA, for the clinical studies still ongoing, if the clinical samples have identical pharmaceutical information with the marketed products, can the enterprise apply for an automatic link to the latest pharmaceutical information of the same product, without submitting an annual report? A: You can apply for the latest pharmaceutical information that is automatically linked to the same product, without submitting an annual report. ( ) 4. NDA NDA 1 NDA 5. MRCT 6. MRCT NDA NDA Activity Brief National Institutes for Food and Drug Control Redesignated as WHO Collaborating Centre for Drug Quality Assurance WHO Recently, the World Health Organization (WHO) re-designated the National Institutes for Food and Drug Control (hereinafter referred to as "NIFDC ) as WHO Collaborating Centre for Drug Quality Assurance, via a letter of high appraisal of the latter s contribution and support to WHO. The new term started on May 26, 2012, and will expire on May 26, In the new term, the duties of NIFDC, as the WHO Collaborating Centre for Drug Quality Assurance, are: establish analysis methodologies for the WHO International WHO WHO WHO CHINA PHARMACEUTICAL NEWSLETTER

7 Pharmacopoeia; establish national drug standard substance; join hands with WHO in the cooperation and research for drug quality control, analytical methods R&D, post-marketed drug quality monitoring (counterfeit drugs detection &analysis) and other aspects; and conduct drug control technical training on drug control technical personnel (especially those from developing countries). On the basis of rigorous examination and meticulous evaluation of NIFDC submissions, the WHO Headquarters officially decided to re-designate NIFDC as WHO Collaborating Centre for Drug Quality Assurance, claiming that NIFDC is a key partner of the WHO in drug quality control with a global influence; WHO Headquarters and other WHO Collaborating Centers highly appraise NIFDC s academic levels and professional competence in drug quality control, and active participation and tremendous contribution to WHO's work." This re-designation provides not only the recognition and support for NIFDC s previous work, but also a good opportunity and platform for the construction of a modern "world-class, China-leading NIFDC in its new term. (June 25, 2012) WHO WHO. WHO WHO WHO WHO WHO WHO WHO Special Focus China's Drug R & D Enters into a New Stage of "Generics + Innovation" With the guidance and promotion of a series of national policies, China's pharmaceutical R & D has entered into a new stage of "generics + innovation" from that of "generics-orientation". In 2011, marked by Icotinib produced by Zhejiang Beta Pharma and other new drugs that have obtained the registration approval as Class I new drugs, China has achieved fruitful results in drug innovation. On the Sino-US Pharmaceutical Industry Forum held in October 2011, Sang Guowei, Vice Chairman of the NPC Standing Committee, announced the achievements of China's Major New Drugs R&D Special Project during the "Eleventh Five-Year Plan" Period: As of the end of September 2010, 16 varieties obtained New Drug Certificates; 24 varieties submitted new drug registration application; more than 10 domestic-innovated drugs were under clinical trials in developed countries; 17 varieties completed all research works; 41 varieties were in the Phase III clinical trial; 96 varieties were in Phase I, II clinical trial; nearly 200 varieties were in pre-clinical research stage; and nearly 500 drug candidates were being studied; among which nearly 2/3 of the new drugs were Class I new drugs whose chemical structures and indications had been for the first time /3 Volume VII

8 determined in the world. Data from SFDA Drug Registration Department show that, in 2011, SFDA approved a total of 644 domestic applications for drug registration, including 124 new drugs, which accounted for 19%. The proportion of new drugs approved saw an increase of 6% year on year. Among them a total of ten Class 1.1 chemicals have been approved, a significant growth compared to that of 2009 and The high level achievement of Class I new drugs is not only an outcome of the national and industry science and technology policies and institutional incentives, but also a manifestation of the initial formation of medical technology innovation system with pharmaceutical enterprises as the mainstay. ( ) 2011 SFDA % 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 Newsletter Newsletter China Center for Pharmaceutical International Exchange (CCPIE) Address: Room 1106, 11th Floor, Office Building B, Maples International Center, No. 32, Xizhimen North Street, Haidian District, Beijing, , P.R.C. 32 B Tel: Fax: lpx@ccpie.org Website: Servier (Tianjin) Pharmaceutical Co., Ltd. Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, Beijing, China Tel: Fax: julie.zhang@cn.netgrs.com Website: 8 CHINA PHARMACEUTICAL NEWSLETTER