The New Drug R&D Technical Guidelines Development in China – Perception of RDPAC Member Companies

1. The New Drug R&D Technical Guidelines Development in China – Perception of RDPAC Member Companies May 17, 2011 Beijing, China • Maggie Chang • Director – Drug Regulatory & Medical Affairs China Association of Enterprises with Foreign Investment • R&D-based Pharmaceutical Association Committee (RDPAC)

2. Outline • RDPAC introduction • ICH technical guidelines • Implementation in China • Introduction of China ICH Study Group • Other technical guidelines • Technical Guidelines Construction in China • Translation of foreign technical guidelines • Recommendation of technical guidelines development in China • Closing remarks

3. Healthier China Through Innovation 创新引领健康中国 Healthier China Through Innovation 为提高患者的生活质量提供医疗保健解决方案 以创新的医疗保健产品和投资，为中国的高速增长提供支持 Providing healthcare solutions to improve patients' quality of life Contributing to the rapid growth of China through innovative healthcare offers and investment

4. 37 Members are R&D-based Pharmaceutical Companies

5. 药学专业组 CMC 治疗用生物制品专业组 Biotherapeutics

6. ICH Technical Guidelines Implementation in China • ICH technical guidelines are well considered during review • Applicants are encouraged to submit CTD format • ICH technical guidelines development are closely followed • Efforts of SFDA/CDE are highly appreciated by RDPAC Member companies

7. Introduction of China ICH Study Group CCD: Center for Drug Certification CDE: Center for Drug Evaluation CDR: Center for Drug Reevaluation CPC: Chinese Pharmacopoeia Commission CQAP: China Quality Association for Pharmaceuticals RDPAC: R&D based Pharmaceutical Association Committee NIFDC: National Institute for Food and Drug Control • Established in 2009, aimed to • Study the ICH technical guidelines in a systematically manner , considering the situation in China, to transform to the technical guidelines suitable for China, organize training and promulgation activities • Follow the progress and changes of ICH technical guidelines, enhance the exchange and cooperation with International Organizations, provide comments and suggestions from the perceptive of China • Boost the continuous improvement of the administration of drug R&D and registration • Led by SFDA, participated by SFDA Technical Affiliates, including NIFDC, CPC, CDE, CCD, CDR, CQAP and RDPAC and academia, experts from local leading R&D-based drug manufacturers to be invited • Major areas including Quality, Safety, Efficacy and Multidisciplinary

8. Major Progress of China ICH Study Group • Working procedures formulated, priorities identified • Studies and training ongoing as planned, webpage and Annual Report 2010 under development • Regular meetings held twice a year • Establishment and activities reported ICH Steering Committee and ICH GCG in 2010 • 22 ICH guidelines translated and to be published in 2011

9. 22 ICH Guidelines Translated in 2009 – 2010 and to be Published in 2011 Q Q3C(R5)、Q4B Annex 1(R1)、Q4B Annex 2(R1)、Q4B Annex 3(R1)、Q4B Annex 4A(R1)、Q4B Annex 4B(R1)、Q4B Annex 4C(R1)、Q4B Annex 5(R1)、Q4B Annex 6(R1)、Q4B Annex 7(R2)、Q4B Annex 8(R1)、Q4B Annex 9(R1)、Q4B Annex 10(R1)、Q4B Annex 11、Q4B Annex 12、Q4B Annex 13、Q4B Annex 14、Q8/9/10 Q&A(R4) 18 S S6(R1) 1 E E2F、E7 Q&A、E16 3

10. MSD’s Efforts on Translation and Publication of ICH Technical Guidelines (1/2) The 1st Edition: Quality: 14 Efficacy: 14 Safety: 13 The 2nd Edition: Quality: 23 Efficacy: 17 Safety: 14 The 3rd Edition: (Guidance updated from 2006 to 2008) Quality: 6 Efficacy: 3 Safety: 4 2001 2007 2011 MSD’s initiative since 1999 and the continuous support and efforts are ongoing…… 1 common goal 10 + experts 100 + translators 108 technical guidelines translated

11. Technical Guidelines Construction Ongoing in China Encouraging Start Solid Progress • 75 technical guidelines officially published by SFDA • 6 general guidelines officially published by CDE • 13 technical standard officially published by CDE • 236 foreign reference technical guidelines translated • 147 foreign reference technical guidelines published by CDE • 31 foreign technical guidelines under conversion

12. 236 Foreign Technical Guidelines Translated by RDPAC Member Companies in 2009-2010

13. Recommendation of Technical Guidelines Development in China • Conversion of prioritized guidelines one by one and step by step • Beginning to end involvement of experts from local companies and MNCs in a systemic way • At least two round publication of draft for seeking public comments • Development of compatible regulations • In parallel translation of latest foreign technical guidelines

14. Closing Remarks • RDPAC member companies are encouraged well by very positive movements of CDE recently • positive re-structuring of the CDE • “Principles and Procedures for Drug Review” published by – a milestone • CTD Format submission • China ICH Study Group is play an important role to introduce ICH technical guidelines into practice in China • Technical guidelines construction in China is a long term project, important for all R&D based pharmaceutical companies in China • RDPAC Member Companies are prepared to support SFDA/CDE for the development of technical guidelines in China

15. Many thanks for your kind attention! maggiechang@rdpac.org • www.rdpac.org