News about GMP/cGMP


ICH: What's new?

The ICH (International Council for Harmonisation) met from 1 to 6 June 2019 in Amsterdam, Netherlands. 

The meeting was the largest biannual meeting of the ICH to date, attended by nearly 500 participants from the sixteen member states and twenty-eight observers of the ICH.

The global circle of the ICH continued to grow in Amsterdam. The ICH Assembly newly admitted the following institutions as "Regulatory Observers":

  • ANMAT, Argentina
  • CPED, Israel
  • JFDA, Jordan
  • SFDA, Saudi Arabia

This brings the total number of ICH observers to 32.

The ICH expert working groups will start work on the following four new topics:

  • Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • E6(R3) Guideline for Good Clinical Practice
  • E2D(R1) Post Approval Safety Data Management: Definition and Standards for Expedited Reporting
  • Guideline on Non-clinical Biodistribution Studies for Gene Therapy Products

Another topic addressed was the Guideline on Impurity: Assessment and Control of Extractables and Leachables (E&L) for Pharmaceuticals and Biologics.

The next ICH meeting will take place from 17 to 21 November in Singapore.

Source: ICH Press Release