Latest Regulatory Updates

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH M15 guideline available on its website, providing further explanation and context for stakeholders.

The ICH PQKM (Pharmaceutical Quality, Knowledge Management) Task Force is seeking input through a Request for Information (RFI) to inform the development of principles and guidance on knowledge management strategies within pharmaceutical quality systems.

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH E6(R3) Annex 2 guideline, which focuses on addendum to clinical trial report format, available for review and feedback on their website.

The International Council for Harmonisation (ICH) has published video training material modules 1-12 related to ICH Q13, providing guidance on quality considerations for technical pharmaceutical product registration.

The ICH Assembly held a meeting in Montréal, Canada, where discussions and decisions were made regarding ongoing and future ICH guidelines and initiatives related to pharmaceutical standards.

The ICH Quality Management Working Group (Q9(R1) IWG) has updated its training materials to facilitate understanding and implementation of the Q9(R1) guideline on quality risk management.

The International Council for Harmonisation (ICH) has released an introductory training video to explain the key concepts and considerations outlined in ICH E8(R1) General Considerations for Clinical Studies, intended to assist stakeholders in understanding and applying the guideline.

The International Council for Harmonisation (ICH) has published a report detailing the results of its 2024 implementation survey, assessing progress in adopting ICH guidelines across various regions and industries.

The International Council for Harmonisation (ICH) has published an introductory training presentation on its website to educate stakeholders about the ICH E11A guideline concerning nonclinical evaluation of juvenile formulations.

The ICH E11A guideline on nonclinical evaluation of juvenile formulations has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.

The International Council for Harmonisation (ICH) is seeking input through a Request for Information (RFI) to inform the potential establishment of a Prospective Pharmaceutical Quality Knowledge Management (PQKM) Task Force, aiming to explore and develop approaches for managing quality-related knowledge throughout the product lifecycle.

The ICH M13A guideline on clinical trial data management and integration has reached Step 4 of the ICH process, indicating it is finalized for adoption by regulatory authorities worldwide.

The ICH Assembly meeting in Fukuoka, Japan, confirmed the adoption of several new guidelines and strategic priorities related to pharmaceutical quality, clinical trials, and other areas impacting global regulatory harmonization.

The ICH M12 guideline on the structure and content of clinical study reports has reached Step 4 of the ICH process, indicating it is ready for adoption by regulatory authorities.

The ICH M14 draft guideline on solid pharmaceutical dosage forms has reached Step 2 of the ICH process, indicating public consultation and feedback are now being sought to refine the guidance.

The International Council for Harmonisation (ICH) has published an introductory training presentation on its website to support understanding and implementation of the updated ICH Q2(R2)/Q14 guidelines regarding quality considerations for clinical trials.

The ICH Q12 IWG has published regulatory and technical considerations for pharmaceutical product lifecycle management, aiming to provide guidance on managing changes throughout a product's lifecycle.

The International Council for Harmonisation (ICH) has made a presentation of the draft ICH E2D(R1) guideline, which addresses clinical investigation protocols and statistical analysis plans, available on its website for review and feedback.

The International Council for Harmonisation (ICH) has published training material for Module 8 of ICH Q12, which addresses regulatory and technical considerations for pharmaceutical product lifecycle management.

The International Council for Harmonisation (ICH) has published training material related to ICH M10 guideline, “Bioanalytical Method Validation and Study Sample Analysis,” to support its implementation and understanding within the industry.