Latest Regulatory Updates

The ICH M13 draft guideline on analytical target profile (ATP) for biotechnological and biologic products has advanced to Step 2 of the ICH process, signifying public consultation and expert review following initial assessment.

The ICH Assembly meeting in Incheon, Republic of Korea, November 2022, resulted in several key decisions including the approval of new guideline drafts and updates to existing guidelines related to pharmaceutical quality, clinical trials, and other areas.

The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH E19, providing guidance on ethnic factors in clinical trials.

The ICH M11 draft guideline on generation of clinical data to support drug authorization has reached Step 2 of the ICH process, indicating it is now open for public consultation and review by regulatory authorities and stakeholder groups.

The ICH Q5A(R2) draft guideline, addressing chemical drug substance and product quality, has advanced to Step 2 of the ICH process, signaling a public consultation phase for stakeholder feedback.

The ICH E19 guideline on Health Technology Assessment (HTA) considerations for drug development has reached Step 4 of the ICH process, indicating it is finalized and ready for adoption by regulatory authorities.

The ICH Addendum to S1B, which provides guidance on the generation of clinical data for registration purposes, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory authorities.

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH M12 guideline available on its website, focusing on statistical principles for clinical trials.

The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH Q3D(R2), providing guidance on impurity thresholds in new drug substances and products.

The ICH Assembly held a hybrid meeting in Athens, May 2022, focusing on strategic priorities and ongoing work related to international harmonization of technical requirements for pharmaceuticals.

The ICH has published a report detailing free text comments received on its guidelines and an implementation study comparing 2019 and 2021 data to assess progress in guideline adoption.

The ICH MIDD DG (Medicinal Product Impurities: Developing Guidance) roadmap outlines the planned activities and expected timelines for developing new guidance related to medicinal product impurities.

The International Council for Harmonisation (ICH) has published an introductory training presentation on its website to facilitate understanding and implementation of the revised ICH E8(R1) guideline on general considerations for clinical trials.

The International Council for Harmonisation (ICH) released a statement expressing its solidarity with Ukraine and outlining measures to support continued operations and engagement despite the ongoing situation.

The ICH E11A draft guideline on nonclinical evaluation of juvenile formulations has reached Step 2 of the ICH process, indicating public consultation and refinement are next.

The draft revised ICH Q2(R2) guideline on quality risk management has advanced to Step 2 of the ICH process, signaling a move towards public consultation and stakeholder feedback.

The ICH Q14 draft guideline on Quality Considerations for Viral Vaccines: Process Development and Manufacturing has reached Step 2 of the ICH process, indicating it is now open for public consultation and refinement.

The International Council for Harmonisation (ICH) has published training material to support the implementation of the ICH E9(R1) guideline on estimation of between-subject variability.

The International Council for Harmonisation (ICH) has published a leaflet providing an overview of ICH's purpose, structure, and activities related to standards development in the pharmaceutical industry.

The ICH Assembly held a virtual meeting in November 2021, discussing progress on various guideline developments and strategic priorities for the organization.