Latest Regulatory Updates

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.

The ICH Q3C(R9) guideline, which addresses impurities in new drug substances, has reached Step 4 of the ICH process, indicating it is ready for adoption by regulatory authorities.

The ICH E2D(R1) draft guideline on clinical investigation of post-approval/post-authorization efficacy endpoints has reached Step 2 of the ICH process, indicating public consultation is now open for review and feedback.

The International Council for Harmonisation (ICH) is seeking proposals from qualified firms to provide technical and regulatory writing services to support its ongoing standards development activities.

The ICH Assembly held a meeting in Prague, Czech Republic, during October/November 2023 to discuss ongoing and future initiatives related to technical guidelines for pharmaceutical product registration.

The International Council for Harmonisation (ICH) has published training materials related to ICH Q9(R1) Quality Risk Management, making them freely available on the ICH website to support implementation and understanding of the guideline.

The International Council for Harmonisation (ICH) has released a reflection paper for public consultation aiming to harmonize terminology related to real-world evidence (RWE) across regulatory regions.

The WHO and ICH have launched a new collaboration to align the International Classification of Diseases (ICD) with MedDRA, enhancing standardized medical terminology for regulatory submissions and improving data quality.

The ICH Assembly meeting in Vancouver, Canada, resulted in decisions regarding the advancement of several strategic initiatives and guideline developments related to pharmaceutical quality, safety, and efficacy.

The International Council for Harmonisation (ICH) has made a presentation detailing the draft ICH E6(R3) Guideline, which focuses on addendum to Good Clinical Practice – Integrated Addendum to ICH E6(R1): Post-Approval/Post-Marketing Clinical Data, available for review and feedback on the ICH website.

The International Council for Harmonisation (ICH) has published introductory training presentations to facilitate understanding and implementation of the ICH M7(R2) guideline on impurities in new drug substances.

The ICH E6(R3) draft guideline on Good Clinical Practice has reached Step 2 of the ICH process, indicating that it is now open for public consultation and review by regulatory authorities and stakeholder groups.

The ICH M7(R2) guideline, which provides international guidance on genotoxic impurities in drug substances and products, has reached Step 4 of the ICH process, indicating it is ready for adoption by regulatory authorities.

The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH Q9(R1), providing guidance on Quality Management principles.

The ICH S12 guideline on clinical evaluation of health products, addressing potential risks related to genetic information, has reached Step 4 of the ICH process, indicating near finalization and readiness for adoption by regulatory authorities.

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH M13A guideline on clinical investigation of drug products containing biotechnologically-derived active substances available on their website, inviting feedback and further discussion.

The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH Q13, providing guidance on quality considerations for technical pharmaceutical product development.

The International Council for Harmonisation (ICH) has advanced the updated Q&As for ICH E2B(R3), concerning post-approval adverse drug reaction submissions, to Step 4 of the ICH process, indicating near finalization and potential publication.