ICH Approves Four New Regulatory Observers and Reviews Progress of Harmonization Efforts

June 19, 2019
Pharmaceutical Technology Editors

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

During its biannual meeting in Amsterdam, The Netherlands, the International Council for Harmonization (ICH) Assembly has approved four new regulatory observers from Argentina (ANMAT), Israel (CPED), Jordan (JFDA), and Saudi Arabia (SFDA), and reviewed the progress made on global harmonization efforts.

At the meeting, ICH reviewed progress made by its working groups, of which 16 were present in Amsterdam. Out of the 16 groups, two were found to have made substantial progress, which resulted in the adoption of various documents by the ICH Assembly. Significant progress was found to have been made in the development of Q&A documents and training materials that will help with the understanding of the developed guidelines.

Four new areas for harmonization were approved during the meeting, which are a proposed update to the ICH Q5A guideline, a revision to the existing ICH E6(R2) guideline, an update to the existing ICH E2D guideline, and a new guideline on non-clinical biodistribution studies for gene therapy products. Work will begin on these new areas as soon as working groups have been established. A further topic, a guideline on impurity, was adopted with a delayed starting timeframe.

Additionally, results of a survey, conducted in early 2019, monitoring the implementation and adherence to ICH guidelines, were presented during the meeting. Aggregated survey results will be made available on ICH’s website later on in the year. 

Source: ICH