Science Committee
IGBA (formerly IGPA) was initially founded to be able to participate as an Interested Party at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This forum brings together the regulatory authorities and the pharmaceutical industries of the European Union, Japan and the USA to discuss scientific and technical aspects of drug registration and develop scientific guidelines. The aim is to achieve greater harmonization and convergence between the various regions so that high quality, safe and efficacious medicines can be developed and registered in the most resource-efficient manner. The IGBA Science Committee’s main activity rotates consequently around the bi-annual ICH meetings. It nominates experts from the generic medicines industry to those Expert Working Groups (EWGs) which are relevant for our industry sector.
Industry experts also participate on an ad-hoc basis in the following WHO activities, programmes and issues:
- Prequalification Programme
- Specification for pharmaceutical preparations
- Paediatrics guideline
- Essential medicines list
- Generics guideline
- INN Programme
- Biological Standardizations
- Similar biotherapeutics guideline
Documents
- IGBA Re-Elected to ICH Management Committee (June 2024)
- IGBA Welcomes update to ICH M7 on Assessment and Control of Nitrosamine Impurities (June 2024)
- Single global development of generic medicines (April 2023)
- IGBA applauds long-awaited scientific harmonization process of bioequivalence studies (December 2019)
- IGBA Joins ICH Management Committee and Welcomes the Positive Vote of the General Assembly (June 2018)
