| Unique harmonization initiative for regulators and pharmaceutical industry ; Founded in 1990
Reformed as a non profit legal entity under Swiss Law on
October 23, 2015
An international nonprofit association that brings regulatory
authorities and pharmaceutical industry together to
HARMONIZE scientific and technical aspects of drug
registration.
Global platform for harmonization | ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) |
| A process where regulatory authorities align
technical requirements for the development and
marketing of pharmaceutical products | REGULATORY HARMONIZATION |
| REGULATORY HARMONIZATION BENEFITS AND REASONS | BENEFITS
- Ensuring favorable marketing conditions to support
early access to medicinal products
- Promoting competition and efficiency
- Reducing unnecessary duplication of clinical testing
REASONS
- Rising costs of healthcare
- Escalation of the cost of R&D
- Need to meet the public expectation |
| Initiation of ICH | 1980s = European Commission, Europe
Discussions between Europe, Japan, US |
| Initiation of ICH: PLANS FOR ACTION BEGAN | WHO conference of Drug Regulatory Authorities (ICDRA), Paris (1989) |
| Initiation of ICH: Joint regulatory-industry initiative on international harmonization | International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) |
| birth of ICH took place | April 1990, Brussels
(European Federation of
Pharmaceutical Industries and Associations (EFPIA) |
| ICH Founding Member Countries | Europe, Japan, US |
| Basis for approving and authorizing new medicinal products | SAFETY, QUALITY, EFFICACY |
| ICH Logo explanation | I, C, H = speaks for benefits of harmonisation for better global health
ABSTRACT HUMAN FORM
Blue Color = Health Care
Purple = Complementary to Blue |
| ICH Slogan | Harmonisation for Better Health |
| to achieve greater harmonisation
worldwide to ensure that safe, effective and high
quality medicines are developed, and registered and
maintained in the most resource efficient manner
whilst meeting high standards. | MISSION |
| PURPOSE OF ICH | 1 REDUCTION OF UNNECESSARY ANIMAL TESTING without compromising safety and effectiveness accomplished through technical guidelines implemented by the regulatory authorities
2 Prevention of unnecessary duplication of clinical trials
and post-market clinical evaluations
3 Development and manufacturing of new medicines
4 Registration and supervision of new medicines
5 Post-authorisation safety reporting and
pharmacovigilance
Accomplished through Technical Guidelines that are
implemented by the regulatory authorities |
| ICH MEMBERS AND OBSERVERS | 1 Founding / Standing Member
2 Member
3 Observer
4 Standing Observer |
| ICH SUCCESSES | 1 GCP (Good Clinical Practice)
2 CTD / eCTD (Common Technical Document)
3 MedDRA (Medical Dictionary for Regulatory Activities) |
| Clinical Trials conducted in one ICH region can be used in other ICH regions by setting common standards on science and ethics | GCP (Good Clinical Practice) |
| Brings together all Quality, Safety, and Efficacy information in a common, harmonised format, accepted by regulators in all ICH regions. It has revolutionised regulatory review processes for regulators and industry | CTD / eCTD (Common Technical Document) |
| Highly specific, standardized medical terminology developed by ICH to facilitate sharing of regulatory information
It is used for registration, documentation and safety monitoring of medical products both before and after marketing authorisation | MedDRA (Medical Dictionary for Regulatory Activities) |
