CHINA PHARMACEUTICAL NEWSLETTER

Volume VII 2011

Published byChina Center for Pharmaceutical International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

SFDA Commissioner Shao Mingli met with new Cuban Ambassador to China On September 29, 2011, Shao Mingli, Commissioner of SFDA met with Mr. ALberto Jesus Blanco Silva, the new Cuban Ambassador Extraordinary and Plenipotentiary to China, and his entourage in Beijing. The two sides held in-depth discussions on further strengthening the bilateral cooperation in

l products and drug safety supervision. (September 30, 2011)

SFDA Deputy Commissioner Bian Zhenjia attends the APEC LSIF Drug Safety and Detection Technology Workshop The APEC Life Science Innovation Forum (LSIF) Drug Safety and Detection Technology Workshop was held in Beijing on September 27-28, 2011. Bian Zhenjia, Deputy Commissioner of SFDA was present at the opening ceremony and made a speech.

Themed on Drug Safety and Detection Technologies, the workshop aims at: sharing information on the appropriate u se o f de t ec t i on and p r even t i on technologies for drug safety and quality by APEC economies; discussing the application of fast detection technologies, improv ing capab i l i t i e s o f APEC economies on cracking down counterfeit medicines; discussing the implementation of the APEC LSIF Anti-counterfeit Medicines Action Plan and building international cooperation to ensure drug safety. (September 14, 2011)

of NPC Standing Committee attended the meeting. Chen Zhu, the Health Minister & Chairman of the Forum attended the forum and delivered a speech.

Chen Zhu said in his speech, through 30 years of reform and opening up, China's GDP has maintained a 10% growth in 30 consecutive years, and created an economic miracle. In 2010, China's GDP had ranked second in the world. In the 21st century, the Chinese Government pays more attention to social development, taking the alleviation of poverty and improvement of health care, education, housing, and employment, etc. as the priorities of public policy.

Chen Zhu stressed that the "Twelfth Five-Year Plan" Period is critical period for China’s heal thcare reform and development, in order to achieve the health development goals within this Period; the Ministry of Health established the following key tasks for healthcare reform:

First, improve the health insurance system.Second, taking the reform of county hospital as a breakthrough, deepen the reform of public hospitals. Third, establish and improve the drug supply guarantee system. Fourth, strengthen the construction of public health and health service systems. Fifth, promote the gradual equalization of basic public health services. Sixth, proactively take advantage of the development of traditional Chinese medicine. Seventh, accelerate the development of health industry. (August 25, 2011)

SFDA Deputy Commissioner Wu Zhen meets the Head of Iran's Innovation and Technology Cooperation Center On the morning of September 6, 2011, Wu Zhen, SFDA Deputy Commissioner, met with the visiting Mr. Hamidreza Amirinia, Head of Innovation and Technology Cooperation Center of Iran. Both parties exchanged views on enhancing mutual exchanges and understanding, and promoting cooperation

and biopharmaceuticals. (September 8, 2011)

SFDA Deputy Commissioner Wu Zhen meets the delegation of MHLW On the morning of August 23, 2011, Wu Zhen, SFDA Deputy Commissioner, met with the visiting delegation headed by Dr. Yoshinobu Hirayama, Councilor for Pharmaceutical and food safety Bureau of the Ministry of Health, Labor and Welfare of Japan (MHLW). Both parties discussed issues such as further strengthening and implementing exchanges and cooperation under the framework of the Memorandum of Understanding, and reached common understanding on relevant issues. The Japanese delegation visited the Center for Drug Evaluation of SFDA in the afternoon. (August 24, 2011)

The Second China Health Forum Held in Beijing On August 18, 2011, the Second China Health Forum, jointly organized by the Ministry of Health, SFDA, and the State Administration of Traditional Chinese Medicine (SATCM), was held in Beijing National Convention Centre, the Forum took the "Sustainable & Healthy Development "as the theme to discuss healthcare reform and development. Han Qide, Vice Chairman

2 CHINA PHARMACEUTICAL NEWSLETTER

GMP

The SFDA Drug Safety Special Campaign Leading Group Held Its Fourth Meeting

SFDA Issued the Public Announcement on GMP

China's Pharmaceutical Industry Comprehensively Initiated

2011 9 8

2011 9 14

2011 9 13GMP 231

82010

GMPGMP 8

2011 9 13

2011 9 6

2011 9 8

On September 8, 2011, the SFDA Drug Safety Special Campaign Leading Group held its fourth meeting, Commissioner Shao Mingli of SFDA stressed at the meeting that conscientious and concrete inspection & evaluation works are called for to enhance the level of drug safety.

The Meeting determined relevant issues to carry out the inspection & evaluation works of Drug Safety Special Campaign, listened to the Drug Safety Special Campaign

On September 6, 2011, the SFDA Work Meeting on the Revision of the Standard Classification of Occupations in China’s pharmaceuticals industry was held in a t the SFDA Ins t i tu te o f Execut ive Development. The meeting studied and formulated the "Implementation Program for the Revision of National Standard Classification of Occupations (drugs &

Office’s report on the implementation of the inspection & evaluation work plan set forth by Six Ministr ies and Commissions to jointly carry out Drug Safety Special Campaign, and the focuses of the forthcoming works. SFDA Deputy Commissioner Bian Zhenjia summarized and affirmed the achievements of Drug Safety Special Campaign in the previous

Special Campaign in the next stage. (September 14, 2011)

medical devices related occupations)", and deployed the specific research on the descr ipt ion of occupat ions . The convening of the meeting marked the overall launch of the revision of Standard Classification of Occupations related to drugs and medical devices.

(September 8, 2011)

On September 13, 2011, SFDA issued the

( N o . 2 3 1 ) . I n a c c o r d a n c e w i t h t h e requirements of SFDA’s “Measures for Drug GMP Certification”, eight pharmaceutical manufacturers including Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd., which comply with the Good Manufacturing Practice for Drugs (2010 Revised Edition),

after on-site inspection, verification and approval.

The eight manufacturers in the f i rs t batch that passed the newly revised GMP Certification are: Jiangsu Chia-

tai Tianqing Pharmaceutical Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd., Qilu Pharmaceutical Co., Ltd., Wuhan Institute of Biological Products, Beijing Tide Pharmaceutical Co., Ltd., Shanghai Celgen Bio-Pharmaceutical Co., Ltd., Nanchang Lijian Pharmaceutical Co., Ltd., and Guangdong Xing Hao Pharmaceutical Co., Ltd. (September 13, 2011)

Volume VII 2011 3

"National Safe Medication Month" Campaign Launched in

State Food and Drug Administration mandated the cessation of the production, sales and application of clenobuterol hydrochloride tablets

2011 9 1

2011 2015 9

2011 9 1

2011 9 23

2009

2011 9 29

On September 1, 2011, the "National Safe Medication Month" campaign was launched in an all-round way, the theme of this year's activity is "Beware of Online Fraud Selling Counterfeit Drugs". Centering on this theme, the food and drug administration departments at all levels will carry out a variety of science promotion activities on safe medication to lead the public to use medicines safely and live a healthy life. At 10: 00AM, SFDA and the food and drug administrations in all provinces, cities and counties held the launch ceremony; SFDA Deputy Commissioner Li Jiping attended the Ceremony at the main venue and delivered a speech.

Accord ing to the "Na t iona l Ac t ion Plan for Food and Drug Safety Science

On September 23, 2011, the State Food and Drug Administration issued a notice on the cessation of the production, sales and application of clenobuterol hydrochloride tablets, by way of revocation of its approval

Since 2009, the State Food and Drug A d m i n i s t r a t i o n h a s o rg a n i z e d a n d implemented a Re-eva lua t ion upon clenobuterol hydrochloride. Upon the literature review of its adverse reactions at home and abroad, the investigations of the production, sales and application in medical institutions at all levels, and the opinions broadly solicited from experts in medicine, pharmacy and other related fields, the Re-evaluation has concluded that clenobuterol hydrochloride tablets have potential risks and limited clinical value, its long-term and inappropriate application may impose serious impact on the cardio-pulmonary function of the patients, therefore the risk

Popularization (2011-2015)" formulated and promulgated by SFDA, In the "Twelfth Five-Year Plan" Period, the "National Safe Medication Month" activities shall be held in September each year. Under the action plan, SFDA will also organize on a nationwide scale the "Food and Drug Safety Knowledge Forum", "Public Service of Video Broadcasts on Food and Drug Safety Knowledge " and outdoor publicity activities for public interest. (September 1, 2011)

of its application in China outweighs its

According to relevant provisions in the Drug Administration Law of China, the State Food and Drug Administration mandated the cessation of the production, sales and application of clenobuterol hydrochloride tablets via revocation of its approval and certification documents; the drugs already produced shall be destroyed under the supervision of local Food and Drug Administration departments.

The other dosage forms of clenobuterol hydrochloride such as aerosol, micropowders and compound preparations are subjected to the management of Prescription Drugs, their appropriate application under the guidance of doctors is safe, and their potential risks of drug abuse are comparatively low, therefore these dosage forms are to be retained.

(September 29, 2011)

4 CHINA PHARMACEUTICAL NEWSLETTER

48SFDA Released the Notice on Converting 48 Kinds of

( ) 10

48 8

40 2011 8 2

48

2006 540

2011 8 16

According to the "Classified Management Measures for Prescription Drugs and Non-Prescription Drugs (Trial)" (State Drug Administration Order No. 10), and with the approval of SFDA, 48 kinds of drugs such as Wound ointment (8 chemicals and 40 Chinese patent medicines) were converted into non-prescription drugs. On August 2, 2011, SFDA released the list of 48 converted drugs and the format of the instruction for these non-prescription drugs. Since the release date, the instructions & labels alteration work for the above varieties can be carried out

in light of the "Notice on the Issuance of Specification Details of the Instructions of Non-Prescription Drugs" (SFDA Department of Drug Registration [2006] No. 540) and the relevant SFDA regulations. (August 16, 2011)

Ketoconazole Preparations

40

2004 1 1 2011 7 12

1621

/

116 7.16%

2 116

157

92

58.60%

2011 8 31

R e c e n t l y, t h e N a t i o n a l C e n t e r f o r Adverse Drug Reac t ion Moni tor ing issued the 40th "Adverse Drug Reaction I n f o r m a t i o n B u l l e t i n " t o r e m i n d healthcare professionals, pharmaceutical manufacturers, distributors and the public to be wary of the severe hepatotoxicity of oral ketoconazole preparations.

From January 1, 2004 to July 12, 2011, the case-report database of the National Center for Adverse Drug Reaction Monitoring has reported a total of 1621 ADR cases of oral ketoconazole preparations, the adverse reactions / events are mainly manifested in damages to the gastrointestinal system, skin and i ts accessories, central and

peripheral nervous system, hepatobiliary system, and systemic damage. In view of the severe hepatotoxici ty of oral k e t o c o n a z o l e p r e p a r a t i o n s , S F D A recommends healthcare workers and patients to choose this drug only when other antifungal therapy fails, and the benefits of its application outweigh its risks; SFDA suggests patients to perform liver function tests prior to treatment, and perform regular checkups during treatment, so as to monitor the signs and symptoms potentially elicited by hepatotoxicity, and reduce the incidence of serious adverse reactions. (August 31, 2011)

Volume VII 2011 5

GMPNotice on the Issuance of the New Version of GMP

2010 GMP

GMP 2011 8 20

GMP

20102011 101

GMPGMP

2011 3 11998

GMPGMP

GMP

GMP

GMP 2011 8 24

For the successful implementation of Good Manufacturing Practice for Drugs (2010 Revised Edition) (Drug GMP), SFDA revised the pattern of "Drug GMP Certificate" and issued the notice on August 20, 2011.

The new Certificates shall be officially in use as of the release date of this Notice. The information on relevant matters is as follows:

F i r s t , a l l p rov inc ia l food and d rug administration departments should follow the requirements of the "Notice on the Implementation of Good Manufacturing Practice for Drugs (2010 Revised Edition) " (SFDA Department of Drug Safety & Inspection [2011] No. 101), re-code and issue new versions of the "Drug GMP Certificates" to formulations (products) that

newly revised Drug GMP. While the original

be issued to formulations (products) that have been accepted for & passed the inspection

Manufacturing Practice for Drugs (1998 Revised Edition) before March 1, 2011.

Second, the new version of the "Drug GMP Certificate" is light blue in paper, while the content, format are identical with the original version.

Third , a l l provincia l food and drug admin i s t r a t i on depa r tmen t s shou ld strengthen the management of "Drug GMP Certificates", conscientiously and orderly performing the coding, registration, and issuance of the Certificates, to ensure the smooth transition.

All provincial food and drug administration departments can, in light of the actual work

in their respective administrative area, contact the SFDA Administrative Service Center and receive the new version of the

(August 24, 2011)

CTDQ & A Answers from the Center for Drug Evaluation of SFDA for submitting dossiers in CTD format

HPLC GC

XVI. In the CTD application dossiers, the quality control section includes the validation of the established analytical methods. However, during the drug product development, much research has been done to establish the analytical method, such as the selection of chromatographic systems, the improvement of method, etc. Is it required to include the development history in the dossier in CTD format? If yes, how should it be described?

A: Actually, establishment of analytical methods includes the analytical method select ion and method val idat ion. Method selection includes the selection of analytical methods (HPLC, GC, HPCE and etc.), the screening and optimization of the chromatographic systems, which includes selection of chromatographic column, constitution and propor t ion of mobi le phase , elution program, flow rate, detection wavelength, e tc . Besides, during drug development, the analyt ical

(To continue)

6 CHINA PHARMACEUTICAL NEWSLETTER

HPCE

3.2.P.5.3

1. 1

2.2

3. 3

4.4

method could also be modified due to manufacturing process and scale changes, al l of which are part of analytical method development and optimization process. The screening and optimization of the chromatographic systems should be provided in the “Validation of Analytical Procedures” section, as required by this module. In addition, information about method improvement should also be shown in the “Val ida t ion of Analy t ica l Procedures” section, especially when the research results obtained by pre- and post-revision methods are used in the drug development, information about method improvement should also be provided in the method research and validation. Meanwhile, it should be noted which data is obtained by the method before revision and which data is obtained after revision. Besides, comparative analysis of the test results obtained by the methods before and after revision should be conducted in order to demonstrate that the improved method can be used to control product quality more effectively.

Above contents can also be submitted as attachments. For example, the following can be listed in the section 3.2.P.5.3 Validation of Analytical Procedures:

1. See Attachment 1 for the development report of related substances test method (The corresponding section of the attachment in the dossier should be noted)

2. See Attachment 2 for the validation protocol and validation report of related substances test method (The corresponding section of the attachment in the dossier should be noted)

3. See Attachment 3 for the development report of dissolution test method (The corresponding section of the attachment in the dossier should be noted)

4. See Attachment 4 for the validation protocol and val idat ion repor t

of dissolution test method (The c o r r e s p o n d i n g s e c t i o n o f t h e attachment in the dossier should be noted)

Detailed data and chromatographic spectrum should be provided in the corresponding attachments.

is provided in the dossier, but they should be easy to read and look for.

X V I I . I n a c c o r d a n c e w i t h t h e requirements of section 3.2.S.4.4 Batch Analyses, in addition to the batch analyses report, the data summary of analyses results of each batch should also be provided. Is it also required to provide corresponding chromatograms for these data? Are there any requirements for the size of these batches?

A: Data summary includes the quality information of the samples at different s tages , wi th different scales and different purposes (such as validation, stability, clinical use, etc.) in drug development; it is helpful to understand the overall conditions of product quality. Different from the batch analyses report, data summary is the summary of important quality specification test results of each batch. The corresponding chromatograms are not necessary to be attached, but they should be properly kept for review.

XVIII. For drug substances, where should the detailed research report of impurities be placed?

A: The impurities study is one of the important information in the quality control research of drug substances. The major study information includes

potential process impurities according to the synthetic process and analysis of possible degradation products according to degradation research), establishment and validation of analytical method, and determination of impurities limit, etc.

In the files in CTD format, the focus

Volume VII 2011 7

CTD 3.2.S.3.2

3.2.S 4.33.2.S.4.5

3.2.S.23.2.S.3 3.2.S.4

3.2.S.5 3.2.S.63.2.S.7

3.2.P.4

1.

2.

of section 3.2.S.3.2 is to analyze the potential impurities (including organic impuri t ies , inorganic impuri t ies , residual solvents and catalysts) in the product in combination with the manufacturing process and degradation pathway study and to describe the control conditions. The establishment and validation information of the impurity analysis method should be provided in section 3.2.S 4.3; the focus of section 3.2.S.4.5 is to explain the jus t i f ica t ion of the impur i ty control limits, including the results of comparative studies.

XIX. In the specif ication l ist , i t is required to “list the number of the methods” in the “method” item, what “number” is it? Does it refer to the number in the appendix of Chinese Pharmacopoeia?

A: The number here refers to the number made by the company according to the internal file management requirement for the convenience of technical management, search and use. It is not related to the number in the appendix of Chinese Pharmacopoeia, unless the method used in the company is the method in the appendix of Chinese Pharmacopoeia.

XX. The dossiers in CTD format require establishing cross index table for t h e a t t a c h e d C h ro m a t o g r a m s . I s i t t o e s t a b l i s h a g e n e r a l C h r o m a t o g r a m s i n d e x o r t o establish the Chromatograms index for each section? Is i t required to submit electronically scanned Chromatograms?

A: For the convenience of review, it is suggested to establish the cross index tables inc luding Chromatograms number, page number in the application dossiers and the test contents in the Chromatograms. (Numbering should be made based on the major items, for example , 3 .2 .S .2 Product ion Information, 3.2.S.3 Characterization, 3.2.S.4 Control of Drug Substance,

3.2.S.5 Reference Standard, 3.2.S.6 Packaging Materials and Containers and 3.2.S.7 Stability). At present, it is not required to submit electronically scanned Chromatograms.

XXI. According to ICH guideline, for the drug product application, the relative technical documents of drug substance (ie.Section 3.2.S) should be submitted together in Module 3. For the domestic drug product application, should this part also be submitted?

A: According to the current regulations, if the drug substance, which is used for the applied drug product, has been approved in China, it is unnecessary to submit its detailed technical documents in drug product application. In this situation, the information of drug substance should be reflected by the corresponding certificates provided by the applicant.

In section 3.2.P.4, regarding drug substance, it is required to provide the source, relative certificates and specification, CoAs from supplier and test report of the drug product manufacturer. Besides, it may also be required to provide the following information:

1. If the drug substance is refined from the approved drug substance

of drug administration route, for

it is required to provide the rationale of developing such a refinement process, the detailed refinement process and the validation data as well as the comparative study report of the quality for the drug substance

specification of the refined product for injection and the justification of

2. If the manufacturer of the drug product has established its own in-house specification for the drug

8 CHINA PHARMACEUTICAL NEWSLETTER

The 16th China International Pharmaceutical

Event of CCPIE

16CHINA-

PHARM 2011 201110 25 28

16

CHINA-PHARM 2011 2011 10 2528CHINA-PHARM

T h e 1 6 t h C h i n a I n t e r n a t i o n a l Pharmaceutical Industry Exhibition (CHINA-PHARM 2011) co-organized by China Center for Pharmaceutical International Exchange and Messe Düsseldorf (Shanghai) Co., Ltd. will be held at Shanghai New International Expo

Center from October 25 to 28, 2011.

CHINA-PHARM has developed into a famous international trade fair which is the most authoritative, representative and influential in pharmaceutical field for more than a decade. The space of

SFDA

CTD

CTD

of the durg substance from the

for the drug substance made by the drug product manufacturer should be provided.

XXII. For the ChP format specification electronically submitted to the CDE website, is it the release specification

A: It refers to the shelf-life specification. After being reviewed and approved by SFDA, the shelf-life specification becomes registration specification of the product which is mandatory and binding.

XXIII. How should one understand the

between them? How to control the limit ranges when establishing the

A: Compared with the corresponding contents in Annex 2 of the Drug Registration Regulation, the release s p e c i f i c a t i o n a n d t h e s h e l f - l i f e specification are specified in CTD format. The establishment of release specification not only completes the quality system, but also shows the quality of process management. The shelf-life specification is used in the quality control from release to the end of expiry date, it is equivalent to the

to ensure that product quality in the shelf life meets the requirements for safety

based on the consideration of safety and efficacy. The release specification is the standard executed when enterprise releases product; it aims to increase certain assurance factor in order for that the product quality after release can

and it is established mainly based on the quality control data and the long-term stability study data of many batches of products after the process is stable. Due to the different purposes of the two specifications, their items and limits are also different. For example, for the impurities limit, it is considered that the impurity content of product will be increased in the process of storage, so

will be generally tighter than the shelf-

XXIV. Can the applicants design relevant tables by themselves and add them into the dossier in CTD format as needed?

A: Relevant tables in the dossier in CTD format can be properly adjusted as needed. When necessary, the tables can be designed by the applicant. It should be noted that relevant information as recommended in CDT format must be shown in the tables designed by the applicant.

Volume VII 2011 9

Special Focus

CHINA-PHARM 2011 is 28,000 m2, and the fair will welcome over 500 exhibitors and 20,000 visitors. Renowned exhibitors and the national pavilions from Germany and UK will expand their stand space to exhibit the state-of-the-art devices and equipment which meets the requirement of new GMP.

CHINA-PHARM 2011 will present the trade visitors with more concurrent academic and technology forums and events. ISPE-CCPIE China Conference, which has cooperated with CHINA-PHARM, will be held in Shanghai from October 25 to 27, 2011 with the theme “Share global best practices and explore the implementation of new GMP”. National Institutes for Food and Drug Control and IPEC China will hold 2011 China Pharmaceutical Excipient Regulatory Conference on October 26.Pharmaceutical and Cleanroom

Technology International Training will be held from October 25 to 26. The Chinese Medicine Injection Forum to be held on October 27.In the meantime, World Health Organization (WHO) and International Drug Information Association (DIA) will also organize training sessions during the fair and release more information to the industry.

On the basis of the exper ience of preceding 15 Exhibitions, The 16th China International Pharmaceutical Indus t ry Exh ib i t i on con t inues t o innovate and tries to build up a good platform of exhibition, communication and coordination for the domestic and foreign enterprises, has a positive effect upon promoting Chinese pharmaceutical equipment, and makes a outstanding contributions to the implementation of the new GMP.

28,000 50020,000

GMPCHINA-PHARM 2011

10 25 27GMP

IPEC China10 26 10 25

2610 27

WHODIA

GMP

Industry Released

2011 8 17 2011 28

2010 TOP

50

On August 17, 2011, the "2011 (28th) Annual Meeting of the Information of National Pharmaceutical Industry" was held in Shanghai. The Meeting released the list of TOP enterprises of China’s

Pharmaceutical Industry in 2010, which comprehensively ranked the business scale of the pharmaceutical enterprises in the previous year; the list of the top 50 enterprises is as follows.

NO Company Name

1 Yangtze River Pharmaceutical Group

2 Xiuzheng Pharmaceutical Group

3 Harbin Pharmaceutical Group Holding Co., Ltd.

4 Shanghai Pharmaceuticals Holding Co., Ltd.

5 CSPC Pharmaceutical Group Limited

6 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

7 North China Pharmaceutical Group Corporation

NO Company Name

8 Weigao Holding Company Limited.

9 Yunnan Baiyao Group Co., Ltd.

10 Northeast Pharmaceutical Group Co., Ltd.

11 China National Pharmaceutical Group Corporation

12 Bayer HealthCare

13 Taiji Group Co., Ltd.

14 Tianjin Tasly Group Co., Ltd.

10 CHINA PHARMACEUTICAL NEWSLETTER

33 Shanghai Roche Pharmaceutical Co., Ltd.

34 Hangzhou Sano -Aventis Minsheng Pharmaceutical Co., Ltd.

35 NHU Holding Group Co., Ltd.

36 Heze Ruiying Pharmaceuticals Group Co., Ltd.

37 China General Technology (Group) Holding Co., Ltd.

38 Lunan Pharmaceutical

39 Nanjing Pharmaceutical Co., Ltd.

40 Renhe (Group) Co., Ltd.

41 Kangmei Pharmaceutical Co., Ltd.

42 Jiangsu Hanson Pharmaceutical Group

43 Fresenius Kabi (China) Investment Co., Ltd.

44 AstraZeneca Pharmaceutical Co., Ltd.

45 Shandong Xinhua Pharmaceutica Co., Ltd.

46 Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.

47 Simcere Pharmaceutical Co., Ltd.

48 Livzon Pharmaceutical Group Inc.,

49 Jiangsu Kanion Pharmaceutical Group Co., Ltd.

50 Henan Wanxi Pharmaceutical Co., Ltd.

2011 8 24(August 24, 2011)

15 Tianjin Zhongxin Pharmaceutical Group Co., Ltd.

16 Beijing Double-Crane Pharmaceutical Co., Ltd.

17 Guangzhou Baiyunshan Pharmaceutical Co., Ltd.

18 Qilu Pharmaceutical Co., Ltd.

19 Zhuhai United Laboratories Co., Ltd.

20 Huiren Group Co., Ltd.

21 Reyoung Pharmaceutical Co., Ltd.

22 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

23 Zhejiang Medicine Co., Ltd.

24 Heilongjiang ZBD Pharmaceutical Co., Ltd.

25 Sichuan Kelun Pharmaceutical Co., Ltd.

26 Xi'an-Janssen Pharmaceutical Co., Ltd.

27 Zhejiang Hisun Pharmaceutical Co., Ltd.

28 P zer Pharmaceutical Co., Ltd.

29 China Resources Sanjiu Medical and Pharmaceutical Co., Ltd.

30 Furen Medicine Group

31 Shandong Buchang Pharmaceutical Co., Ltd.

32 Jiangsu Hengrui Medicine Co., Ltd.

The Export of Western Medicine Products Witnessed a

210.56 31.19%2010 5.74

17.73% 11.43%

131.3627.05% 2010

25.02% 1.63%

In the first half of 2011, China's total import and export value of western medicine products amounted to $ 21.056 billion, an increase of 31.19% in equal terms, and up by 5.74 percentage points comparing with the 2010 full-year growth rate. The momentum of rapid development still maintained. Meanwhile, the import & expor t volume and the average price increased by 17.73% and 11.43%

that the international market’s demand for Western medicine products is growing steadily, and China’s international trade of western medicine products is expected to

maintain a rapid pace of development.

western medicine products topped 13.136 billion U.S. dollars, up by 27.05 percent, and maintained a high growth trend since 2010.

In the first half of 2011, the exports of western medicine products continue to improve, the exports grew by 25.02%, the average export price increased by 1.63%, and it is gratifying that the volume and price still both increased. However, the price-volume relation of three major categories of products changed greatly, the exports of

Volume VII 2011 11

35.16% 4.83%96% 43.19%

68.42%314% 9.45

30.71%110.43 28.63%11.49 11.34%

185

86.52%56.78

31.72%38.53 22.95%

26.33%13.83% 18.35

8.86%140%

46.16% (2011 8 18 )

APIs and biochemicals rose in volume while drop in price, the export volume of APIs increased 35.16%, but the prices fell 4.83%; biochemical exports jumped up by 96%, but the average price plummeted by 43.19%. Western patent medicine, by contrast: export volume plummeted by 68.42%, while the average export price rocketed by 314%. From the perspective of export value, the export of Western patent medicine is $ 945 million, which enjoyed the greatest increase up to 30.71%; that of APIs is 11.043 billion U.S. dollars, an increase of 28.63%; that of biochemicals is $ 1.149 billion, up by 11.34%.

medicine products have exported to 185 countries and regions. Asia, Europe and

North America remain to be China’s major export markets with a share of 86.52%. The volume and price of export to Asian and European market both increased, the export to Asian market amounting to $ 5.678 billion, an increase of 31.72%; exports to European markets is $ 3.853 billion, up by 22.95%. While the market conditions in North America were slightly different, exports grew 26.33%, but the average export price fell by 13.83%, the final exports value is $ 1.835 billion, an increase of only 8.86% in equal terms. The exports to the fastest-growing Oceania market increased by 140%, while exports to Latin America market, which ranked second in growth rate, increase by 46.16%. (August 18, 2011)

Table The export statistics of China's Western medicine products in the First half of 2011 Quantity Unit: ten thousand tons Value Unit: U.S. $2011

Commodity Name Exportamount

Growth rate inequal terms (%)

Exportvalue

Growth rate inequal terms (%)

AveragePrice

Growth rate inequal terms (%) Proportion

Western Medicine 335 25.02 131.36 27.05 3.92 1.63 100

APIs of Western Medicine 307 35.16 110.42 28.63 3.6 -4.83 84.06

Western patent medicine 95 -68.4 9.45 30.71 9.49 3.14 7.2

Biochemicals 17.73 96 11.49 11.34 6.48 -43.2 8.47

On June 1, 2011, China Pharmaceutical Association (CPA) organized experts to assess the 20 candidates of “The 14th CPA - Servier Pr ize for Young Investigators in Medicinal Chemistry”. F i v e w i n n e r s , i n c l u d i n g Z h o u Yu , who came from Shanghai Institute of Materia Medica of Chinese Academy of Sciences, were determined as awardees

after the final assessment by French Serv ie r Resea rch Ins t i tu te . Awards will be presented at Chinese Medicinal Chemistry Symposium (CMCS 2011) that will be held in Guangzhou during 17-20 November 2011.In 1997, the French Servier Research I n s t i t u t e p r o p o s e d t o t h e C h i n e s e Pharmaceutical Association (CPA) the

The Assessment Results of “The 14th China

Investigators in Medicinal Chemistry” Announced

2011 6 1

–

20

2011 11

17 20 2011

1997

Special column

Provided by Servier (Tianjin) Pharmaceutical Co., Ltd.

12 CHINA PHARMACEUTICAL 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, 100082, P.R.C.

32 B 11 1106100082

Tel: 010-8221 2866 Fax: 010-8221 2857Email: lpx@ccpie.orgWebsite: www.ccpie.org

Servier (Tianjin) Pharmaceutical Co., Ltd.

Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, 100020 Beijing, China

Tel: 010-6561 0341Fax: 010-6561 0348E-mail: julie.zhang@cn.netgrs.comWebsite: www.servier.com.cn

Notes: All Chinese information in Newsletter extracted from Newspapers and Internet. AllEnglish articles are the translations from the Chinese version.Read the electronic version of the newsletter please visit http://www.ccpie.orgNewsletter

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2004

creation of the “CPA-Servier Prize for Young Investigators in Medicinal Chemistry”. This proposition was accepted immediately and supported s trongly by the CPA, especially inspired by Pr. ZHANG Li-He, the former Vice-President of the CPA. It is an annual prize and provides RMB 15,000 for each winner (RMB 10,000 before 2005). It aims to encourage the outstanding y o u n g i n v e s t i g a t o r s i n M e d i c i n a l Chemistry to dedicate to drug research based on domest ic circumstances in China. Since 2004, an additional prize, “CPA - Servier Special Funded Project for Young Investigators in Medicinal

Chemistry”, was established to help the young postgraduates from depressed areas improve their levels of scientific research.Fourteen years since its creation, “CPA - Servier Prize for Young Investigators in Medicinal Chemistry” has made positive contributions in the encouragement of outstanding young investigators in novel drugs research and development. As the most important prize in medicinal chemistry that encouraging and rewarding the young researchers in China, CPA and French Servier Research Institute will continue to sustain the Prize.