TGA and Medsafe

ICH aim to become more transparent in pursuit of greater harmonization

The ICH Steering Committee and its Expert Working Groups met in Belgium in June 2013. The Steering Committee agreed measures aimed at increased transparency in pursuit of greater harmonisation and will provide more detail to the public via the ICH website, including agendas and the reports of meetings as well as the work plans of active expert working groups.

A new organisational structure will also be adopted and will set the framework for new rules on governance, decision making and membership. To promote greater involvement of global regulators, the ICH Global Cooperation Group (GCG) was successfully integrated into sessions of the ICH Steering Committee.

Q3D: Impurities: Guideline for Elemental Impurities was also discussed. This draft guideline (not yet released to the public) contains 3 elements: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE.

The Q7 (GMP Guide for API’s) Working Group met for the second time in view of developing a Q&A document to address current issues raised by the use of the Q7 Guideline. This work is carried out in collaboration with PIC/S.

The Press release for the meeting in June can be found here. Further information is available on the ICH website.

The next ICH Steering Committee and its Expert Working Groups meetings will be held in Japan in November 2013.