The Progress of ICH

1. The Progress of ICH C. Michelle Limoli, Pharm. D June 2010 VICH Conference

2. International Conference on Harmonisation

3. Three Regions, Six Parties

4. Expert Working Groups STEERING COMMITTEE Monitors and Facilitates EWGS

6. Over 60 ICH Guidelines Efficacy � 9 topics/ 21 guidelines Safety - 9 topics/14 guidelines Quality - 10 topics/36 guidelines Medical Dictionary - MedDRA Electronic Standards - ESTRI, E2B Common Technical Document - CTD Guidelines extend over entire product life cycle

7. Regulators� Concerns About CTD Initially the ICH regulators were resistant to change to their submission format Regulators felt it would be too disruptive to their review process They needed to be convinced there was value in harmonizing the submission format A feasibility study was requested of industry

8. Industry Resource Survey Conducted in May 1996 The survey evaluated the time it took to convert an FDA NDA into an EMEA submission (and the reverse) It also evaluated the number and types of staff needed to carry out the conversion of submission formats

9. Conversion Times

10. Staff Needed for Conversion

11. Conclusion: Tackle CTD Regulators realized the amount of time and energy needed to rearrange paper from one ICH region submission format to another Conversion caused a delay in submitting an application to that ICH region Resulted in delayed access to new innovative medicines for patients in that region

12. One of the integrating uniform numbering system for the entire CTD. measures that was agreed to in May was a Here we have a �refinement� of the CTD pyramid reflecting that system. One of the integrating uniform numbering system for the entire CTD. measures that was agreed to in May was a Here we have a �refinement� of the CTD pyramid reflecting that system.

13. Benefits of the CTD - FDA Perspective More reviewable applications More logical order of presentation Follows development scheme More predictable format More consistent reviews Easier analysis across applications Easier exchange of information Facilitates electronic submissions

15. Electronic Submissions

16. Summary-Influence of the CTD/eCTD The CTD format of a submission influences the content of a review by imposing a consistent order of information and data provided The CTD shapes both the conduct of the review and the presentation of the results of the review Consistency of CTD format should promote consistent review practices (GRPs) and efficiency As more countries utilize ICH guidelines and the CTD format a common regulatory language will evolve promoting interactions between regulatory authorities

17. CTD Timeframe CTD signed off November 2000 Mandatory in EU and Japan and Highly Recommended by FDA July 2003 Less than five years later eCTD and review templates! Lightening speed in government time!

18. ICH Outreach Efforts:Global Cooperation Group Created in 1999 to address increasing interest by non-ICH parties in ICH guidelines and operations Facilitates dissemination of information on ICH activities, guidelines and their use GCG underlying principle: ICH will not seek to impose its views--rather, GCG will serve as resource for information Four brochures published on ICH and GCG, available at ICH website

19. ICH GCG Members Asia Pacific Economic Cooperation (APEC) Australia, Brunel Darussalam, Canada, Chile, People�s Republic of China, Hong Kong, China, Indonesia, Japan, Republic of Korea, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, Philippines, Russia, Singapore, Chinese Taipei, Thailand, United States, Vietnam Association of Southeast Asian Nations (ASEAN) Brunel Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam The Cooperation Council for the Arab States of the Gulf (GCC) United Arab Emirates, Bahrain, Saudi Arabia, Oman, Qatar, Kuwait Pan American Network for Drug Regulatory Harmonization (PANDRH) Regulators from PAHO/WHO, Regulatory Associations of the Pharmaceutical Industry, NAFTA, SICA, CARICOM, MERCOSUR, TLCA, Consumer Groups, Academia, Regional Professials Associations, Latin American Association for Integration (ALADI), The Andean Community Southern African Development Community (SADC) Angola, Botswana, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Narribia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia, Zimbabwe

20. Shift in Focus for GCG: Initial focus on information-sharing Soon became clear that more active engagement was necessary to respond to increasing interest in ICH and ICH guidelines November 2003: An Important Milestone Endorsement by ICH SC of new Mandate and Terms of Reference that call for The ongoing participation of regional harmonization initiatives Greater transparency

21. GCG Mission Statement Finalized 2003: To promote a mutual understanding of regional initiatives in order to facilitate harmonization processes related to ICH guidelines regionally and globally; and to strengthen the capacity of drug regulatory authorities and industry to utilize them.

22. Regulators Forum Initiated in 2008 ICH Regulators, GCG and regulators of Australia, China, Chinese Taipei, India, Korea Assist with implementing ICH guidelines Regulators only Met for the first time prior to ICH meetings in Portland, June 9, 2008 Created to promote discussion and sharing of best practices among regulatory authorities on issues related to the implementation of ICH guidelines and impact on regulatory systems The Regulators� Forum will complement activities and objectives of GCG

23. ICH Week

24. ICHAct Strategically: New Topics Maintenance Mode

25. Maintenance Mode Continued Modernization Updating Guidelines Strengthening Partnerships: WHO Pharmacopeias SDOs

26.