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1、GMP IN CHINAChallenges & OpportunitiesShanghai Food and Drug Administration Center for Certification & EvaluationHua Zhang June 28 , 2010 1GMP Challenges and OpportunitiesOverview of China pharmaceutical industryImportance of GMP for developing pharmaceutical industry in ChinaGMP trends in China21.O
2、verview of China Pharmaceutical Industry3Status of China Pharmaceutical Industry 2004 2007100 millions of RMB100 millions of RMBSource: The Southern Medical Economy Research Institute, SFDA4Sales Revenue of China Pharmaceutical Industry - 2007 100 millions of RMB100 millions of RMBSource: The Southe
3、rn Medical Economy Research Institute, SFDA5100 millions of RMB100 millions of RMBSales Revenue of China Pharmaceutical Industry - 2007Source: The Southern Medical Economy Research Institute, SFDA6Profit of China Pharmaceutical Industry 2007100 millions of RMB100 millions of RMBSource: The Southern
4、Medical Economy Research Institute, SFDA7100 millions of RMB100 millions of RMBProfit of China Pharmaceutical Industry 2007Source: The Southern Medical Economy Research Institute, SFDA8Overview of China Pharmaceutical Manufacturers - 2007Source : SFDAUnit：Company9Overview of Injectable Products Manu
5、facturers in China - 2007Source : SFDA10Sale Revenues Concentration Degree of China Pharmaceutical Industry 20032005Source: The Industrial Map of Pharmaceuticals 20062007 11Characteristics of China Pharmaceutical IndustryHighly dispersedLack of diversityMostly generic drugsLow profit with intensive
6、competitionWeak brandNo global business development experiencesA lot potential but unstable 12Dilemmas faced by China Pharmaceutical IndustryGaps in management philosophy and methodology with global standardsNegative effects of medicine scandalsWeak R&D capability, absent of new productsIncreasing p
7、ressure in energy, environment protectionUncertainty of medical insurance policies132. GMP is very important for Development of Pharmaceutical Industry in China14We Are Entering into a New EraHigh economic growth of ChinaImprovement of peoples living standardScientific innovation is consensusIncreas
8、ing attentions and protections of Intellectual PropertyGlobalizationGlobal harmonization of drug regulations and standards15We Are Entering into a New EraChinese manufacturers begin to go beyond low cost Increasing attentions to technology and design Improving product added valueUK Financial Times M
9、ay 29, 200816Possible Ways Out of DilemmasDomestic market To reduce cost and increase efficiency To strength product development and extend market share To adjust product profiles To start new drug R&D17Global market Drug formulation OEM from overseas CRO R&D of generic drug API & formulations Devel
10、opment of new drugsPossible Ways Out of Dilemmas18Importance of GMP Compliance for China Pharmaceutical Industry GMP is the major measure to assure the safety, efficacy, quality of medical products From quality compliance to quality suitability19Total Control Strategy to Ensure Product Quality & Con
11、sistencyQuality SpecificationProduct characterization during developmentGMP: suitable facilities, validated mfg. process, validated test procedure, raw material testing, IPC, stability testing, etc.Product quality and consistencyReference: ICH Q6A20GMP is the major measure to assure the safety, effi
12、cacy, quality of medical products From quality compliance to quality suitability Realistic requirements and possibilities of Chinese pharmaceutical industry to improve GMP implementation Pressure for survive Profound lessons learned from medicine scandals With necessary talents and related resources
13、 GMP is foundation to benefit from the manufacturing advantagesImportance of GMP Compliance for China Pharmaceutical Industry21Formulation OEM from OverseasAvoid the weakness of innovation，bring out advantages in large production capacity and low costsStarting from oral solids and external dosage fo
14、rmsStarting from terminal-sterilized injections22Experiences and LessonsClear market position is criticalThe early bird catches the worm Need well-trained talents Guarantee of product qualityTechnical innovation is the foundation23Successful Case studyShenzhen Lijian Pharmaceutical Co., Ltd Funded i
15、n 2001 Passed EU GMP inspection of Cephalosporin products including sterile powder injections, capsules, tablets, suspension and granules in July 2006 Reasons for success Plant built with global standard Sterile APIs are provided from associated companies Long term cooperation with foreign partners
16、Excellent team Achieved by persistence 24Failed Case StudyOne Domestic company OEM was foreseen Passed EU GMP inspection in 2003 Under utilized production capacityReasons Lack of experience Inaccurate market position Small production scale253. GMP Trends in China26GMP Defectives Analysis in Shanghai 2003200427Trends of GMP i
