News about GMP/cGMP


ICH: What's new?

The ICH (International Council for Harmonisation) met in Singapore from 16-20 November 2019. More than 450 participants attended the meeting and fourteen Working Groups met to progress their work.

A particularly noteworthy milestone is:

  • ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalised in Singapore and has reached Step 4 of the ICH process.

“The guideline complements the ICH Quality Guidelines Q8 - Q11, aims to promote innovation and continual improvement in the pharmaceutical sector and strengthens quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments” the ICH says.

  • E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analysesand the new M9 Guideline on Biopharmaceutics Classification System-Based Biowaivers have also reached Step 4.

Furthermore, the Assembly approved concept paper outlines for two topics raised at its previous meeting in Amsterdam last June:

  • ICH Q9 Guideline on Quality Risk Management and
  • M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The start time for a revision of ICH Q9 will be delayed in view of other ongoing quality work.

A new  Working  Group  is  now  being  established  to  initiate  work  on  the  new  topic  proposal  on  ICH  Q3E  Guideline  Impurity:  Assessment  and  Control  of  Extractables and Leachables for Pharmaceuticals and Biologics.

Several new  Working  Groups  also  advanced  work  in  Singapore  on  their  respective  new  topics  with  the  finalisation of Concept Papers and Business Plans on:

  • E6(R3): Good Clinical Practice
  • E2D(R1): Post Approval Safety Data Management: Definition and Standards for Expedited Reporting
  • E20: Adaptive Clinical trials
  • Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • S12: Nonclinical Biodistribution Studies for Gene Therapy Products
  • M12: Drug Interaction Studies

The next ICH meeting will take place on 23-27 May 2020 in Vancouver, Canada.


ICH: Press Release