Introduction to the ICH Guidelines

Basic information for beginners...

1. Brief Introduction to the ICH Guidelines By, CHANDRA MOHAN

2. What does ICH stand for ? Initiation of ICH The Evolution of ICH What is the purpose of ICH ? Organisation of ICH Members & Observers ICH Harmonization Process ICH Guidelines

3. What does ICH stand for? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH ) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law What for Decrease country-to-country differences in guidelines Decrease differences between regulatory authorities

4. Initiation of ICH Harmonisation of regulatory requirements was started by the EC, Europe, in the 1980s, as the EC, Europe moved towards the development of a single market for pharmaceuticals. At the same time there were discussions between Europe , Japan and the US on possibilities for harmonisation. It was, however, at the WHO Conference of Drug Regulatory Authorities ( ICDRA ), in Paris, in 1989, that specific plans for action began to materialise. Soon afterwards, the authorities approached International Federation of Pharmaceutical Manufacturers and Associations ( IFPMA ) to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived . The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels.

5. The Evolution of ICH Since ICH's inception in 1990, the ICH process has gradually evolved. ICH's first decade saw significant progress in the development of ICH Guidelines on Safety, Quality and Efficacy topics. Work was also undertaken on a number of important multidisciplinary topics, which included MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common Technical Document). As ICH started into a new millennium, the need to expand communication and dissemination of information on ICH Guidelines with non-ICH regions became a key focus.

6. What is the purpose of ICH? Promotion of public health through international harmonisation that contributes to : Prevention of unnecessary duplication of clinical trials and post market clinical evaluations Development and manufacturing of new medicines Registration and supervision of new medicines Reduction of unnecessary animal testing without compromising safety and effectiveness Accomplished through Technical Guidelines that are implemented by the regulatory authorities.

7. Faster access to medicines around the world Better use of limited resources Reduced duplication Sharing experience and knowledge Fewer clinical trials needed Fewer animals needed for basic research Training and capacity building with regulators and industry will be key What is the purpose of ICH?

8. Organisation of ICH

9. The Auditors are appointed for a period of two years and may be re-appointed. The responsibility of the Auditors is to audit the financial statements of the Association upon conclusion of each Fiscal Year.  ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of ICH.   ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of all Members, including administrative and financial matters and oversight of the Working Groups (WGs). The MC is responsible for submitting recommendations or proposals to the Assembly in preparation of Assembly discussions MedDRA Management Committee (MC) has responsibility for direction of MedDRA , an ICH standardised dictionary of medical terminology. ICH Secretariat is responsible for day-to-day management of ICH, coordinating ICH activities as well as providing support to the Assembly, the ICH Management Committee and its Working Groups. The ICH Secretariat also provides support for the ICH MedDRA Management Committee. The Secretariat is located in Geneva, Switzerland

10. ICH Coordinators Fundamental to the smooth running of ICH has been the designation of an ICH Coordinator per ICH Member to act as the main contact point with the ICH Secretariat. Coordinators ensure proper distribution of ICH documents to the appropriate persons from their organisation and are responsible for the follow up on actions within their respective organisation within assigned deadlines. They also assist communication between the ICH Management Committee and/or Assembly and the ICH Working Groups as needed . An ICH Working Group (WG) is established for each technical topic selected for harmonisation. There are several different types of ICH working group: EWG: Expert Working Group is charged with developing a harmonised guideline that meets the objectives in the Concept Paper and Business Plan. IWG: Implementation Working Group is tasked with developing Q&As to facilitate implementation of existing guidelines. Informal Working Group: Is formed prior to any official ICH harmonisation activity with the objectives of developing/finalising a Concept Paper, as well as developing a Business Plan. Discussion Group: Is a group established to discuss specific scientific considerations or views i.e. Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group.

11. Members & Observers Members

12. Members & Observers Observers

13. ICH Harmonization Process

14. ICH Guidelines The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.

15. Quality Guidelines

16. Safety Guidelines

17. Efficacy Guidelines

18. ICH Successes (1)

19. ICH Successes (2)

20. ICH Successes (3)

21. THANK YOU! Questions ?