Michelle Limoli, Pharm.D. Conference of the Pan American Network for Drug Regulatory Harmonization September 5, 2013 Overview of ICH Governance: Lessons Learned Michelle Limoli, Pharm.D. International Programs/OSP Center for Drug Evaluation and Research US Food and Drug Administration The views expressed in this presentation are those of the author and do not necessarily represent the views of the U.S. Food and Drug Administration

ICH: A Unique Approach ICH was created in 1990 Agreement between the European Union, Japan and the United States to harmonize technical requirements for registration of pharmaceuticals for human use Joint effort by regulators and associated trade associations

Three Regions, Six Parties Europe EU EFPIA Japan MHLW JPMA United States of America FDA PhRMA Observers: Canada, EFTA, WHO The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in 1990. It is a unique initiative involving both regulators and industry from the EU, Japan and the US as equal partners.

Monitors and Facilitates EWGs Expert Working Groups SAFETY EFFICACY QUALITY REGULATORY COMMUNICATIONS STEERING COMMITTEE Monitors and Facilitates EWGs

Steps of ICH Harmonization STEP 5--Implementing Guidelines in ICH Regions STEP 4--Adopting Harmonized Guidelines STEP 3--Consulting Regional Regulatory Agencies STEP 2--Agreeing on Draft Text The five steps the ICH process represent joint initiatives between regulators and industry and agreement between the European Union, Japan, and the USA. In the last decade, the ICH has published more than 50 guidelines in the areas of animal testing, drug quality, and clinical testing. STEP 1--Building Scientific Consensus

Steering Committee Governs ICH Determines ICH policies, procedures and direction Decides on adoption of new topics/projects Monitors & facilitates progress of Expert Works Groups (EWGs) Signs off ICH documents

ICH Products 60 Guidelines on technical requirements: Quality - 21 Guidelines Safety - 14 Guidelines Efficacy - 20 Guidelines Multidisciplinary - 5 Guidelines Electronic Standards for the Transfer of Regulatory Information (ESTRI, E2B) Common Technical Document (CTD & eCTD) Medical dictionary for adverse event reporting and coding of clinical trial data (MedDRA) Consideration documents

Keys to ICH Success: Well-defined process and procedures Effective management and administration (permanent Secretariat) Limited number of participants with common focus Science-based and consensus driven Frequent, concurrent meetings of SC and WGs that are outcomes based Comparable regulatory, technical and financial capacity Commitment of all parties to implementation

Evolution of ICH Success of ICH and uptake of work products => catalyst for modifications: Expanded participation Outreach to other countries Governance changes Increased transparency

Expanded Participation May 1996 Generic industry experts included in Quality Expert Working Groups (EWGs) OTC industry experts included in Quality and appropriate Efficacy topics EWGs

Expanded Participation November 2003 Regional Harmonization Initiatives (RHIs) invited to ICH mtg & included in the Global Cooperation Group APEC ASEAN GCC PANDRH SADC EAC (2011)

Expanded Participation May 2005 Definition of Interested Parties created (those that regulate by or are regulated by ICH guidelines) to assure that they were included in appropriate ICH discussions and EWG meetings. (OTC, generics, API, biotech industry) 12

Expanded Participation November 2005 RHIs invited to observe ICH Experts Working Group meetings. 13

Expanded Participation October 2006 SC Decides to collaborate with Standards Development Organizations (SDOs) to take advantages of their open, consensus based process in the development of electronic standards associated with the eCTD 14

Expanded Participation June 2008 Regulators from individual countries invited to ICH meeting and joined the Global Cooperation Group: Australia India Brazil Korea China Russia Chinese Taipei Singapore 15

Expanded Participation April 2011 ICH SC opens Expert Working Groups to RHIs, DRAs, DoH as expert members (not only as observers), with following criteria: Demonstrated support for the use of ICH guidelines Experts possess appropriate knowledge Commitment to participate in all discussions over life of topic development Self-financed travel 16

Expanded Participation June 2013 The ICH Global Cooperation Group was integrated into sessions of the ICH Steering Committee in order to promote greater involvement of global regulators. 17

Expanded Participation 2013 - Ongoing The ICH SC is currently discussing options to increase the opportunity for more active engagement of regulators & industry stakeholders beyond the “founding” regions: Preserving/increasing the efficiency & accountability of ICH process Controlling costs Increasing transparency of the process 18

Revised Governance June 2012 ICH SC creates new Regulatory Chair position for EWGs, to ensure regulatory oversight & integrity of the entire process: Must be from a regulatory ICH party Oversees EWG work at Steps 1-4 Monitors timeframes, scope adherence and process Work closely with Rapporteur and reports to the SC 19

Revised Governance June 2012 In order to better define the roles of the regulatory and industry parties, the SC revised the harmonization process by separating Step 2 into Step 2a & Step 2b. This distinguishes and separates technical standards work from regulatory policy decisions. 20

Increased Transparency November 2005 Decision to publish summary of SC actions and decisions (summarized report) on ICH website 21

Increased Transparency June 2006 SC decides to post Concept Papers and Business Plans for all new ICH topics. This provided for earlier notice of new topics under discussion (instead of at Step 3 when documents were posted for public comment) 22

Increased Transparency June 2013 SC decides to post on the ICH website: Agenda Report of SC meetings Work plans of active EWGs ICH Procedures document 23

Increased Transparency Newly revised ICH Website User Friendly All guidelines, draft & final, press releases, meeting information Educational modules Anyone can comment on ICH Guidelines ICH Website PANDRH rep ICH Coordinators Public Consultations Help to Shape the ICH Guidelines 24

www.ich.org

Continuing Evolution of ICH Given the global environment in which we now operate, the continued success & relevance of ICH will depend upon broader use of ICH guidelines and standards ICH must evolve to meet the changing global paradigm Expanded participation in ICH is expected to benefit, industry, regulators and patients => Faster access to innovative medicines

Thank you for your attention