At the International Council for Harmonisation’s (ICH) meeting in Singapore, the status of activity of the ICH’s Working Groups was reviewed, including several important updates on implementation and communication.
A key milestone reached by the ICH Working Groups was the adoption of the new ICH Q12 Guideline (Step 4 of the ICH process) on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline, aims to promote innovation and continual improvement in the pharmaceutical industry, and strengthen quality assurance and reliable supply of products, including proactive planning of global supply chain adjustments.
Furthermore, new Working Groups finalised 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 ICH Assembly also agreed on new topic proposals including “Bioequivalence for Immediate-Release Solid Oral Dosage Forms”, and a “Guideline on Quality Risk Management”. Additionally they received a report from the MedDRA Management Committee on efforts to support the ever increasing number of global users, including the expanded number of MedDRA training offerings.
Further discussions took place on ICH guideline implementation, training related activities and effective communication with stakeholders. For more information on the Assembly meeting, click here.