Latest Regulatory Updates

The International Council for Harmonisation (ICH) is inviting interested parties to submit an Expression of Interest for a tender related to the Management Support Services Office (MSSO).

The ICH S10 guideline, addressing nonclinical safety testing of gene therapies and cell therapies, has reached Step 4 of the ICH process, indicating it is finalized for adoption by regulatory authorities.

The ICH Steering Committee meeting in Osaka, November 2013, resulted in decisions regarding the advancement of several guideline projects related to topics including gene therapy and risk minimization guide.

The International Council for Harmonisation (ICH) has published a brochure, "Understanding MedDRA," to provide an introductory overview of the Medical Dictionary for Drug Regulatory Activities (MedDRA) and its role in regulatory submissions.

The International Council for Harmonisation (ICH) has made its procedures, which detail the operational aspects of ICH working and management, available for download on the ICH website to ensure transparency and facilitate understanding of ICH's processes.

The ICH Steering Committee (SC) in June 2013 made several decisions regarding ongoing and new projects, including updates to guidelines on topics such as Q3A(R2), impurity thresholds, and gene therapy.

The ICH Q3D guideline, addressing genotoxic impurities in drug substances and products, has advanced to Step 2b of the ICH process, indicating a draft version will soon be available for public consultation.

The International Council for Harmonisation (ICH) has launched a new MedDRA (Medical Dictionary for Regulatory Activities) website, providing enhanced functionality and resources for users involved in regulatory submissions.

The ICH Steering Committee meeting in June 2013 resulted in several decisions including the endorsement of Q9 Quality Risk Management and the approval of a new strategic approach for future guideline development.

The ICH Management Board held a meeting in La Hulpe, Belgium, discussing progress on various standards projects related to medical device terminology and other regulatory harmonization initiatives.

The ICH M7 guideline on genotoxic impurities in drug substances and products has advanced to Step 2 of the ICH process, indicating public consultation is now open for review and feedback.

The ICH E2C(R2) guideline on Good Clinical Practice - Bridging Reports, has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.

The ICH S10 guideline, addressing the electronic submission of nonclinical data for pharmaceutical products, has advanced to Step 2 of the ICH process, signifying public consultation and refinement.

The ICH Steering Committee has revised the S1 strategy, focusing on a more structured and phased approach to addressing evolving scientific and technological advancements in drug substance manufacturing.

The ICH Steering Committee meeting in San Diego resulted in several decisions including endorsement of the Q3A guideline on impurities in new drug substances and approval of a strategy for addressing real-world data.

The MedDRA Management Board meeting in San Diego, November 10-11, 2012, focused on ongoing and future activities related to the maintenance and enhancement of the Medical Dictionary for Drug Regulatory Activities (MedDRA).

The ICH is seeking feedback on a draft eCTD Implementation Guide as part of Step 2 testing, aiming to refine the guidance for electronic submissions.

This announcement provides a detailed record of the discussions that occurred during the International Council for Harmonisation (ICH) Genetic Characterization (GCG) Committee meeting in June 2012, focusing on topics related to genetic characterization guidelines.

The International Council for Harmonisation (ICH) has released updated guidance documents to support the implementation of MedDRA (Medical Dictionary for Regulatory Activities) version 15.1, providing clarity and instructions for users.

The ICH Steering Committee meeting in Fukuoka resulted in decisions regarding the progression of several guidelines, including Q12 on pharmaceutical product registration strategy for clinical trial data and a roadmap for future guideline topics.