CHINA PHARMACEUTICAL NEWSLETTER

Volume V 2011

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

SFDA Signed a Memorandum with the Guangxi Zhuang Autonomous Region Government on the Co-Construction of A Demonstration Area for Food & Drug Safety Cooperation In order to promote and expedite the development of food and drug administration in Guangxi, and improve the capacity of Guangxi Government for international cooperation with ASEAN in respect to food and drug safety, on June 20, 2011, SFDA signed a Memorandum with the Guangxi Zhuang Autonomous Region Government on the co-construction of a demonstration area for food & drug safety cooperation. SFDA commissioner Shao Mingli and Chairman of Guangxi Autonomous Region Ma Biao signed the Memorandum respectively on behalf of the two parties.

The Cooperation Memorandum should be made to build a scientific, unified and efficient food and drug regulatory

promote scientific development, so that Guangxi can become a National Food and Drug Safety Demonstration Area. (June 22, 2011)

SFDA Deputy Commissioner Wu Zhen meets Director-General of Public Health of the Netherlands Ministry of Health, Welfare and Sport On June 21, 2011, Wu Zhen, Deputy Commissioner of SFDA, met with the visiting Paul Huijts, Director-General of Public Health of the

S F D A C o m m i s s i o n e r S h a o Mingli meets Director of Health of the Government of the Hong Kong Special Administrative Region On the morning of June 10, 2011, Shao Mingli, Commissioner of SFDA and Dr. P.Y. LAM, Director of Health of the Government of the Hong Kong Special Administrative Region had an annual high-level meeting in Sichuan province. Both sides reviewed the cooperation i n d r u g s u p e r v i s i o n , e x c h a n g e d opinions on the implementation of the new version of Good Manufacturing Practice for Pharmaceutical Products (GMP) of China, the TCM standards and the establishment of an information n o t i f i c a t i o n s y s t e m , a n d m a d e discussions on an extensive and in-depth cooperation in the next stage.

(Jun 13, 2011)

SFDA Commissioner Shao Mingli meets CEO of MHRA On May 23, 2011, Shao Mingli, SFDA Commissioner, met with the visiting Kent Woods, CEO of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), and his entourage. Both sides exchanged opinions on the new version of GMP of China, the pharmacovigilance of Britain and how to deepen the cooperation under the framework of the Memorandum of Understanding in the future. (May 24, 2011)

Ministry of Health, Welfare and Sport of the Netherlands, and his entourage. Both sides exchanged opinions on the implementation of GMP, China's medical device supervision, the drug supervision in the Netherlands and in the Europe, and reached common understanding on bui ld ing b i la te ra l coopera t ion mechanism and signing a memorandum of understanding in the next stage.

(Jun 22, 2011)

S F D A D e p u t y C o m m i s s i o n e r Wu Zhen meets with Ms. Susanne Keitel, Director General of European Directorate for the Quality of MedicinesIn the morning of May 16, 2011, SFDA Deputy Commissioner and Secretary-General of Chinese Pharmacopoeia Commission Wu Zhen had friendly talks with Ms. Susanne Keitel, Director General of European Directorate for the Quality of Medicines in State Food and Drug Administration. The two sides exchanged views on China-EU Pharmacopoeia bilateral cooperation to further deepen the cooperation in this respect including pharmaceutical standards cooperation, personnel exchanges and certification training on API suitability etc. Meanwhile, Deputy Commissioner Wu Zhen and Ms. Susanne Keitel reached a consensus on the Global Pharmacopoeia Summit that is scheduled to be held this year in Beijing.

(May 26, 2011)

2 CHINA PHARMACEUTICAL NEWSLETTER

The Revised Provisions for Adverse Drug Reaction Reporting and Monitoring Issued

2011 5 24

7 1

2004

8 67

,

2011 5 24

T h e n e w l y r e v i s e d P r o v i s i o n s f o r Adverse Drug Reaction Reporting and Monitoring was issued on May 24, 2011, and will be officially implemented as of July 1, 2011.

The “P rov i s ions fo r Adve r se Drug Reaction Reporting and Monitoring” (hereinafter referred to as the" Provisions "), promulgated and took effect in 2004, is an important legal basis to carry out Adverse Drug Reaction Monitoring in China. The revision of the "Provisions" caters for the Drug Administration departments’ implementation of the Scientific Concept of Development and the requirements of health care system reform, it is another major initiative for ensuring people's well-being and guarantying the safe use of drugs. The implementation of the "Provisions" will further promote the enforcement of various works concerning the Adverse Drug Reaction Monitoring that constitutes a protective screen to guarantee drug safety for the people.

According to drug regulatory requirements a n d A D R m o n i t o r i n g r e c o r d s , t h e n e w l y r e v i s e d " p r o v i s i o n s " t h a t i s made amendments, improvements and modifications by Ministry of Health and SFDA, comprises 67 articles in eight chapters, including the general provisions, responsibilities, reporting and handling, intensive monitoring, evaluation and control, information management, legal liabilities and supplementary provisions. It gives clearer definitions of the responsibilities of the regulatory departments and Adverse D r u g R e a c t i o n ( A D R ) m o n i t o r i n g

the procedures and requirements for ADR reporting and makes additional requirements for the investigation, verification and evaluation of serious adverse drug reactions and mass adverse drug events. It adds requirements for intensive drug monitoring and makes clearer and higher requirements for manufacturers to actively carry out ADR

monitoring.

S F D A r e q u i r e s f o o d a n d d r u g administration departments at all levels s t r eng then t he l e ade r sh ip on ADR reporting and monitoring, conscientiously perform the education, publicizing and implementation of the newly revised "Provisions"; strengthen the institution-building and capacity-building for grass-roots ADR monitoring institutions to improve the capacity for ADR information c o l l e c t i o n , r e p o r t i n g , a n a l y s i s , evaluation and handling; establish and improve ADR monitoring systems and procedures, refine the implementation deta i ls , operat ional procedures and work standards for ADR monitoring, to improve its institutionalized, standardized and scientific levels; and work in close coordination and cooperation with health administrative authorities to strengthen the reporting, investigation, handling, etc. for massive ADR events, so as to ensure the enforcement, order and effectiveness of ADR monitoring work, and improve the early warning capabilities and levels for drug safety .

SFDA requires drug manufacturers , distributors and medical institutions a c t i v e l y m o n i t o r , r e p o r t , a n a l y z e and evaluate adverse drug reactions, i n p a r t i c u l a r , t h e p h a r m a c e u t i c a l manufacturers should take the initiative to strengthen ADR monitoring, and take active risk management measures to control drug risks. (May 24, 2011)

Volume V 2011 3

SFDA’s Three Major Projects in the Support Program of the "Eleventh Five-Year Plan Period" are All Accepted

24 15

8

H1N1 EV71

11 15

12 16S rRNA

7

13439 2010

238

34RFID

2011 6 13

R e c e n t l y, t h e S o c i a l D e v e l o p m e n t Department of the Ministry of Science and Technology held the Acceptance Meeting for Projects in the National Key Technology Support Program of the "Eleventh Five-Year Plan Period", two SFDA-sponsored Projects: "Research on the Safety Evaluation Technology for Biological Products and the Safety of Raw Materials and Excipients" and "Research on China's Drug Administration and Testing Technologies that Urgently Need to Be Established and Improved" all obtained the acceptance of the experts. Plus the "Drug Safety Action Plan" that has been accepted by the experts On 15 April this year, at this point, SFDA’s three major projects in the Support Program of the "Eleventh Five-Year Plan Period" are all accepted.

The "Research on the Safety Evaluation Technology for Biological Products and the Safety of Raw Materials and Excipients" project is composed of eight sub-projects, which aim to develop a series of key technologies on the safety of biological products (particularly about vaccine safety), from the safety testing of the production of raw materials (toxic bacteria species, cells, excipients, animal-derived materials) to pre-clinical safety evaluation, toxicity evaluation

time in China developed the safety evaluation technologies for new vaccines such as BCG,

and inactivated EV71 virus vaccine; and key technologies and methods for the testing and control of vaccine immunotoxicity, employing these technologies, the Project has completed relevant vaccine safety evaluation. The Project has also developed a series of testing methods for bacteria (virus) strains in vaccine production, safety testing for cells, and residue detection in biological products like ampicillin, kanamycin, gentamicin, glycoprotein conjugate vaccines

etc. The Project has made the complete gene sequence analysis of 11 kinds of vaccines for routine immunization and 15 bacteria (virus) strains, and established the genome database for relevant bacteria (virus) strains,

16S rRNA in 12 kinds of bacteria for vaccine production, and established corresponding gene genome database and archives.

T h e " R e s e a r c h o n C h i n a ' s D r u g Administration and Testing Technologies that Urgently Need to Be Established and Improved" project is composed of seven sub-projects, involving the identification

impurities, tests for the composition and harmful elements of mineral drugs and preparations, detection technology of harmful residues of exogenous material in TCM, narcotic drug safety testing methods, the safety evaluation methods for pharmaceutical excipients, injection safety and quality control standards, on-site rapid testing system for drugs, research on radio frequency identification technology for traceability management of drug safety etc. The Project has developed a total of 134 pharmaceutical quality standards, 39 of which have been recorded in the 2010 edition of Chinese Pharmacopoeia, two of which have been promulgated as national drug standards. The Project has developed 38 species of reference substance for impurities in national chemical drugs, and 34 calibration standards of reference substance for impurities, established on-site rapid testing system for drugs, and developed a RFID-based traceability technology information system for drug distribution.

The relevant technologies researched and developed in these Projects will play an important role for the technical support to enhance drug safety monitoring and administration. (June 13, 2011)

4 CHINA PHARMACEUTICAL NEWSLETTER

SFDA Sets Limit Standard for Residual Sulphur Dioxide in Chinese Crude Drugs and Prepared Slices of Chinese Crude Drugs

SFDA Raises Alert against Serious Allergic Reactions of Asarone Injections

2011 610

11

400 mg/kg150 mg/kg

WHO

2011 9 9 (2011 6 10 )

38

-

2004 1 1 2011 2 28

5631710

/

1

62

3

(2011 06 10 )

In order to prevent abuse or excessive usage of su lphur fumiga t ion in the primary processing of Chinese crude drugs and ensure the quality, safety and effect iveness of t radi t ional Chinese medicines, SFDA formulated the limit standard for residual sulphur dioxide in Chinese crude drugs and prepared slices of Chinese crude drugs. The draft standard is open to public opinion by the Chinese Pharmacopoeia Commission as of June 10, 2011. According to the draft standard: the maximum residue l imit of sulfur

Recently, the National Center for ADR Monitoring released the 38th Volume of "Adverse Drug Reaction Information Bulletin" to notify the serious allergic reactions of asarone injections.

The main ingredients of Asarone injection

gramineus, an Araceae plant. There are three dosage forms, namely, asarone injection, asarone for Injection, and asarone sodium chloride injection.

From January 1, 2004 to February 28, 2011 , the Case-Repor t Da tabase o f National Center for ADR Monitoring (hereinafter referred as "the Case-Report Database ") has reported a total of 5631 cases in connection with asarone injection, and a total of 710 serious cases, the main adverse reactions / events are: anaphylactic shock, anaphylactoid reaction, dyspnea, laryngeal edema, cyanosis, palpitations and so on.

According to the analysis of the information from the Case-Report Database, SFDA requires that:

1. Before prescribing asarone injection,

dioxide is 400 mg/kg for 11 specified kinds of Chinese crude drugs and prepared slices of Chinese crude drugs which traditionally applied sulphur fumigation, such as Chinese yams, achyranthes roots and lobed kudzuvine roots; the maximum residue limit of sulfur dioxide is 150 mg/kg for all the other kinds of Chinese crude drugs and prepared slices of Chinese crude drugs.The deadline for the comments solicitation will be September 9, 2011.

(June 10, 2011)

the doctors should ask in detai l the pa t ien t ' s p rev ious a l l e rg ic records , so as to prohibit the prescription for patients allergic to the ingredients of this product, and prescribe with caution to patients of allergic constitution and children under 6.

2. Administrate asarone injections in strict accordance with the methods and dosages provided by the instructions, avoid overdose, and apply monotherapy as much as possible. Close monitoring should be made during the administration, should chest tightness, shortness of breath and other early allergy symptoms occur, drug withdrawal or appropriate treatment measures should be immediately taken.

3. Manufacturing enterprises should improve the product instructions with more safety-related information; enhance the publ ic i ty of reasonable c l in ica l application of drugs, to ensure that the product safety information can access in a timely manner to the patients and physicians; and conduct post-marketing safety studies.

(June 10, 2011)

Volume V 2011 5

Four Government Departments Jointly Issued a Notice to Further Crack down Government on Releasing False Drug Information and Selling Drugs Illegally via the Internet

2011 5 18

2011 5 31

In order to consolidate the rectification achievements, continuously intensify the crackdown on releasing false drug information and selling drugs illegally via the Internet, and maintain strict supervision, SFDA, Ministry of Industry and Information Technology, Ministry of Public Security and State Administration for Industry and Commerce jointly issued a notice May 18, 2011, to further crack down on releasing false drug information and selling drugs illegally via the Internet.

The Notice requires the strengthening of daily supervision on the drug information services and Internet trading service websites that have already been approved, strengthen the dynamic monitoring on false drug information, advertising and illegal sale of drugs on the Internet, and severely crack down criminal acts of selling counterfeit drugs via the Internet.

The Notice stressed that the departments o f 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 , communications management, public

secur i ty, industr ia l and commercial administration in all provinces (autonomous regions and municipalities) should fully recognize the importance and urgency of cracking down on releasing false drug information and selling drugs illegally via the Internet; earnestly implement various tasks with close attention and careful deployment; set great store to the publicizing of the importance and work achievements of cracking down on releasing false drug information and selling drugs illegally via the Internet; expose websites that release false drug information and sell drugs illegally, and guide the public to purchase drugs from legitimate channels.

( May 31, 2011)

2010

SFDA Releases Information about the National Drug Abuse Monitoring Annual Report (2010)

2010

2010

2010

2010

2006 2010

Recently, SFDA released the information about the National Drug Abuse Monitoring Annual Report (2010).

D r u g a b u s e m o n i t o r i n g r e l i e s o n systematic collection of cases of narcotic and psychotropic drug abuse in special populations, to study and analyze the characteristics and changes of drug abuse, forecast drug abuse trends, and provide basic data and decision-making reference for the scientific monitoring of narcotic and psychotropic drugs and anti-drugs works.

The National Drug Abuse Monitoring Annual Report (2010) makes an analysis

on the overall situation of China’s drug abuse monitoring in 2010, and describes the condition of drug abuse in China in 2010. Through an analysis on relevant monitoring data from 2006 to 2010, it presents the change of features of the drug abuse in China as well as the prediction on the future trend of drug abuse in China.

The Report includes five aspects of the overall situation of drug abuse monitoring in 2010, covering the monitoring of new drug abusers, heroin abuse, new-type drug abuse, and medical drug use and abuse. The report shows that in 2010 China's drug abuse status and trends has the following characteristics: First, heroin

6 CHINA PHARMACEUTICAL NEWSLETTER

2010

2010

2011 5 19

and methamphetamine ("ice") are the major and most popular substance for drug abusers; Second, new drug abuse represented by "ice" showed a rising trend, while the popularity of traditional drugs l ike heroin decreased; Third , medical narcotic drugs and psychotropic drugs abuse remained at a low level, early warning reports for these kinds of drug abuse reduced. Fourth, the "multiple drug abuse" is rather serious in some areas. The Report shows that China's drug-abuse situation remains severe, and its prevention task remains arduous.

Drug abuse prevent ion i s a k ind of complex system engineering. Relevant works such as preventive education, treatment and behavioral interventions, drug administration, the fight against

illegal manufacturing and trafficking of drugs involves a lot of areas and d e p a r t m e n t s . N a r c o t i c d r u g s a n d psychotropic substances are indispensable in medical practice, to prevent the abuse of these drugs for medical use, SFDA and relevant departments have taken a series of measures to strengthen the routine supervision and inspection, regulate production and operational order, timely adjust the control range of varieties, so as to protect the legal demands for narcotic and psychotropic drugs, and prevent the trafficking to illicit channels. SFDA has also set up Drug Abuse Monitoring N e w s l e t t e r C o l u m n i n g o v e r n m e n t websites to introduce relevant information of drug abuse, and warn the public to consciously stay away from drug abuse.

(May 19, 2011)

SFDA Revised the Instructions Templates for Some Non-Prescription Drugs

2010

( )

2011 05 19

To ensure the safe use of drugs for the public, according to the "Provisions for the Classified Management of Prescription and Non-Prescription Drugs (Interim)", relevant laws and regulations, and the

edition "Chinese Pharmacopoeia", SFDA revised the instructions templates for some non-prescription drugs such as the Ejiao Sambo Cream, Baikejing Syrup, Alopecia Areata Pills, Bupi Yichang Pills, Buzhong Yiqi Wan, Buzhong Yiqi Wan (Watered Pills), Changyanning Tablets, Changyanning Syrup, Danguixiang Granules, etc.

(May 19, 2011)

Volume V 2011 7

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

I. Are the data in the format of CTD submitted now equivalent to the original No.7-15 data in the CMC part? Are the remaining parts still written in the original format? Is it submitted electronically in the original path? Will No. 7 data be written separately in the CMC part? Is there any need to submit paper data for those in CTD format? If needed, is it available to be written and bound in parts? Is there any principle for volume division?

A: Yes, only the research data in the CMC part can be written and submitted in CTD format at present. The remaining parts including the overview data, the research data about pharmacology and toxicology as well as the clinical e x p e r i m e n t a l d a t a r e g u l a t e d i n Attachment 2 of the Provisions for Drug Registration are still written and submitted in the original format.

The CMC par t in CTD format i s equivalent to No.7-15 data of the pharmacological research data regulated in Attachment 2 of the Provisions for Drug Registration. It should be declared in CTD format. The data in the CMC part should be written according to the requirements in the attachment of the Notification on Relevant Matters of Writing Data about Registration and Declaration of Chemical Drugs in CTD Format (SFDA [2010] No.387) issued by State Food and Drug Administration on September 25, 2010. There is no need to write No.7 data regulated in Attachment 2 of the Provisions for Drug Registration separately, but it should be noted that the Summary List about the Declaration of Major Research Information in CTD Format must be submitted according to the requirements.

The paper data of the declaration data

and the summary list of major research information in CTD format should be submitted and bound in parts as the case may be. If volume division is needed, it should be noted that “Volume , volumes in total” on the cover of the declaration data. It is suggested that the contents in the same module should not be bound in parts.

The summary list of major research informat ion should be submit ted electronically, and the contents in the electronic version should be identical to the paper documents. The present submittal way is the same as that for specification, instruction manual, packing label and manufactur ing process.

II. Will it be accepted if the data in CTD format are submitted in IND stage? The original data about imported drugs of which the declaration data are prepared according to Registration Classification 3 is in CTD format, while would it be required to submit them in the format of Attachment 2 in the IND period and in CTD format in the NDA period?

A: No matter whether it is the application for imported drugs or domestic drugs, applicants can select the format of the declaration data by themselves. It is acceptable to submit data in CTD format in IND stage.

For your reference, no matter whether the CTD format or the format in Attachment 2 of the Provisions for Drug Registration is selected, the requirements of research data and information which need to be submitted are identical, so as the standard during the review.

III.Is it needed to rearrange and submit complete CMC data in CTD format

CTD

CTD

7-15 CTD

2010 9 25 CTD

[2010]387

7CTD

CTD

CTD

CTD

8 CHINA PHARMACEUTICAL NEWSLETTER

in time of Class 3, 4, 5 declaration of production?

A: N o m a t t e r i n w h a t r e g i s t r a t i o n classification and declaration period, applicants should sort out and submit complete pharmacological if the CTD format is selected.

IV. Should the chromatogram attached to the declaration data be put together or attached in parts separately?

A: It is suggested that the chromatogram should be attached to every part for the convenience of review.

V. Is there any need to divide the data in CTD format into open part and

A: CTD is a kind of format file used to offer guidance in writing and submitting declaration data. At present, since declaration data are only used in the supervision and regulatory authority, there is no need to distinguish open and confidential part. The division and management of open and confidential parts will be defined through other management policies such as Drug Master File (DMF).

VI.The data in CTD format need to be submitted electronically, is it also needed to submit the chromatogram in electronic version?

A: At present, it is only required to provide the electronic version of the summary list of major research information. There is no need to submit the electronic version of the text and chromatogram of declaration data for the time being.

VII. It is required not to change the serial numbers of the items in CTD format, while different contents may be involved in the corresponding experimental process. Is it available to make the secondary numbering in the corresponding item numbering?

A: The serial numbers and order of every module specified in “the composing requirements of declara t ion data of chemical drugs in CTD format”

including “the Summary List about the Declaration of Major Research Information in CTD Format” (SFDA [2010] No.387 attachment ) can not be changed.

When research data are filled in every module, applicants may make secondary numbering in the existing numbering themselves according to the conditions in order to show the research result clearly. It should be noted that numbering must

made in the contents for the convenience of reference.

VIII. F o r i m p o r t e d p r o d u c t s , i f application is only made for the import of Drug products, is there any difference in the declaration requirements of drug substance and pharmaceutical preparations?

A: For imported products, even though application is only made for the import of preparations, considering the demand on supervision and control, it is required to not only provide the research data of pharmaceutical preparation, but also provide the research data of drug substance. It can be sorted and submitted according to the requirements for drug substance and pharmaceutical

You are advised that the declaration data of drug substance should include complete information of open part and confidential part. If applicants o f p h a r m a c e u t i c a l p r e p a r a t i o n s really have difficulty in submitting confidential part of drug substance, the manufacturer can submit relevant data to the SFDA Center for Drug

CTDCTD

CTD

DMF

CTDCTD

2010387

CTD

Volume V 2011 9

Evaluation directly.

IX.Is it also needed to provide detailed data about structure elucidation for impurities less than the identification limit in characteristic identification? For impurities in the starting raw materials not affecting the quality of finish products, is there any need to

in the intermediates, is there any need

A: Generally, there is no need to provide research data about structure elucidation

threshold. If it is genotoxicity impurity or potential genotoxicity impurity, the structure needs to be specified. If the impurities in the starting raw materials are not brought into finish products and have no impact on the quality of finish products, generally, there is no need to make structure elucidation of the impurities. If the impurities in the intermediates have no impact on the quality of finish products, there is generally no need to make structure elucidation either.

X. If the crystallization of products from the synthetic process we design is needed in the pharmaceutical preparations, and the production process can make the crystallization s t e a d i l y ( c o n f i r m e d t h r o u g h

study of other crystallization of the product, or only needed to list the indicator method and properties of other crystallization?

A: First of all, the research purpose should be clarified. For innovative drugs, the research purpose of crystallization is to screen crystallization with stable nature and relatively high bioavailability; for generic drugs, the research purpose of crystallization is to obtain the same crystallization as that in the product of the original listed manufacturer, or the crystallization whose stability and bioavailability has no difference from that of the crystallization in the product of the original listed manufacturer in

spite of different crystallization. For the foresaid issue, if it is innovative drug, the overall research should be made on crystallization; if it is generic drug, the crystallization is needed in pharmaceutical preparations, it can be obtained steadily in commercialized production, and the crystallization will not be changed in the process of the storage of crude drugs as well as the product ion and s torage of pharmaceutical preparations, there is no need to make further study on other crystallization.

XI.Is it needed to verify the upper limit and the lower limit of the scope of key process parameters in process development and process validation? How about general parameters? If validation must be made, is it available to take the requirements of validation with the highest point, the middle point and the lowest point?

A: The scope of key process parameters is generally determined according to the results of study at early stage (Bench-scale test and pilot-scale test) and the experience in large-scale production. If the boundary challenging test of parameter scope has been completed in the study at the early-stage, the challenging study on the highest point and the lowest point will not be carried out generally when process validation is made. For general process parameters, if it is proved through study that the change of parameters is irrelevant to production scale, it can be directly enlarged when production is expanded.

10 CHINA PHARMACEUTICAL NEWSLETTER

New Books Introduction

IMS

2015 1.1

5

3% 6%

5 6.2%

A recent Research report of IMS shows that by 2015, global pharmaceutical consumption will reach $ 1.1 trillion, the data reflects that the compound annual growth rate of the global drug consumption over the next five years is about 3% to 6%, a relatively slow growth compared with the 6.2% rate in the past

IMS 20151.1

IMS Forecast: 2015 Global Pharmaceutical Consumption Amount to $ 1.1 Trillion

Special Focus

Accelerated decline in the proportion of Brand Consumption

All in all, the market share of the global Brand Name Drugs has fallen from 70% in 2005 to 64% in 2010, and further decline to 53% by 2015 as estimated.

80

2011 6 30

"The Latest Provisions and Guidelines for Drug Registration"

Food and drug safety is an essential component of public safety, it is directly related to people's livelihood and social stability. Recently, a Book Series on the laws and regulations for food and drug administration is being compiled under the auspices of the State Food and Drug Administration. The Book Series is the first official publication that has

the current laws, regulations, rules and normative documents for food and drug

administration, it aims to provide a practical, exercisable and comprehensive reference book series for the majority of food and drug administration law enforcement personnel and related professionals, and to facilitate the citizens, legal persons or other organizations to systematically study, grasp, abide by and enforce relevant laws, regulations and administrative rules in food and drug administration.

listed on the market - "The Latest Provisions and Guidelines for Drug Registration" has comprehensively recorded the latest laws and regulation documents for China’s current drug registration and nearly 80 technical guidelines for drug research, highlighting the comprehensive, authoritative and practical features of the Book Series. The publication of the book shall play a positive role to promote the popularization of China’s provisions and policies related to drug registration, comprehensively carry out administration according to law in the drug administration system, and guide pharmaceutical manufacturers to conduct scientific drug registration works accordingly. (June 30, 2011)

Volume V 2011 11

2005 70% 2010 64%

2015 53% IMS

2015 80%

2005 2010

540 2015

980

220 2015

1200

5

2850 3150 2010

1510

IMS 2015

2010

5

2500 3000

2010

600 650 2015

650 750

IMS believes that although there has been a robust growth in branded products in the emerging markets, it is estimated that by 2015, 80% of the drug consumption in the emerging markets shall transfer to that of the generic drugs.

Mature markets benefit from high-volume expired patents

According to statistics, from 2005 to 2010, patent expiration of branded products has saved $ 54 billion for consumers, by 2015, this net savings shall exceed $98 billion; with $ 22 billion generics consumptions, by 2015, patent expiration shall have a total of $ 120 billion savings for consumers.

gaps

Many new drugs recently released or to be released aim to prolong life or improve the patients' life quality with significant and brand new treatment options. These include: oral drugs for multiple sclerosis has greater efficacy and facilitate drug administration; two recently promoted arrhythmia therapies have for the first time expanded the treatment choices in

melanoma therapy that improves survival rate; breakthrough in personalized health care and so on.

Drug consumpt ion in emerg ing markets approximates to U.S. levels

drugs in emerging markets is estimated to reach $285 - 315 billion, doubled as compared to the $ 151 billion in 2010. This result is attributed to the robust economic growth in these areas and the government's support to expand treatment options. IMS forecasts that by 2015, drug consumption in emerging markets will be close to the U.S. levels, and become the second largest pharmaceutical consumer market.

Health care policy’s long-term impact on consumption

A series of policies released in 2010 globally will have a significant impact on drug consumption in the next five years, including: the U.S. Affordable Care Act has expanded the heal th insurance coverage from 25 million to 30 million; China's drug price control policy that ensures the sustainability of universal health care; Japan has for

policy under the policy protection of new drugs; Spain and Italy have marked down the prices of generic drugs and drugs with expired patents; and Germany's mandatory cost-benefit evaluation of new drugs. In addition, the rebates and discounts not reflected on the amount of invoices are also becoming more widely accepted by the public and private consumers, which have amounted to about $60 billion to 65 billion in 2010, and will rise to 65 billion to $ 75 billion by 2015.

The rapid development of biosimilars but its application is limited

IMS speculated that by 2015, annual consumer spending on biosimilars will exceed $ 2 billion, or account for about 1% of the total expenditure for global biological agents. New biogenerics are

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

Newsletter http://www.ccpie.org

IMS 2015

20

1%

2014

2010 31.1

IMS 2015

5% 8%

4% 7%

2% 5%

2010 370

310 2011 6 14

expected to enter the U.S. market in 2014. European market will also introduce other biosimilar drugs. This will accelerate the pace of biosimilars consumption on the

basis of $ 3.11 billion in 2010.

IMS also pointed out a number of important therapeutic categories by 2015: cancer treatment will continue its leadership position, targeted therapy that has been widely used maintained a 5% to 8% slow growth; With the rising prevalence of diabetes and the emergence of new oral drugs against diabetes, DM spending shall have a growth of 4% to 7%; while the growth for asthma and chronic obstructive pulmonary disease treatment will slow down to 2% to 5%; and the spending of lipid regulating agents will decline from U.S. $ 37 billion in 2010 to $ 31 billion. (June 14, 2011)