Latest Regulatory Updates

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.

The International Council for Harmonisation (ICH) has published Q&As to clarify the structure and content of clinical study reports, providing further guidance on adherence to ICH E3 guidelines.

The MedDRA Management Board meeting in Fukuoka, Japan, on June 2-3, 2012, focused on ongoing and future activities related to the maintenance and enhancement of the Medical Dictionary for Drug Regulatory Activities (MedDRA).

The ICH Steering Committee has endorsed the creation of an Expert Working Group (EWG) S1 to address evolving expectations for process understanding and control in drug substance manufacturing.

The International Council for Harmonisation (ICH) has advanced ICH Q11, Development and Manufacture of Drug Substances, to Step 4 of the ICH process, indicating it is nearing completion and publication as an official guideline.

The International Council for Harmonisation (ICH) has released updated guidance documents to support the implementation of MedDRA (Medical Dictionary for Regulatory Activities) version 15.0, providing clarity and instructions for users.

The International Council for Harmonisation (ICH) has published additional questions and answers related to the M3(R2) guideline on statistical principles for clinical trials, providing further clarification for stakeholders.

The ICH E2C(R2) guideline on Good Clinical Practice - Bridging Report, has reached Step 2 of the ICH process, indicating that it is now open for public consultation and review.

The International Council for Harmonisation (ICH) has published a set of Questions and Answers (Q&As) related to combination drug toxicity testing, providing further clarification on the M3(R2) guideline.

This announcement details the key decisions made by the ICH governing body in November 2011, covering topics such as Q3A(R2) impurity guidance, Q5D technical document on excipient control of drug substances, and other ongoing initiatives related to international harmonization of pharmaceutical standards.

The International Council for Harmonisation (ICH) has added supplementary points to consider regarding Quality Risk Management (Q8), Pharmaceutical Quality System (Q9), and Development Lifecycle Interconnectedness (Q10) on their website, providing further clarification and guidance for stakeholders.

The International Council for Harmonisation (ICH) has updated its webpages dedicated to the Expert Steering Committee on Regulatory Information (ESTRI), providing revised information and resources related to regulatory submission standards.

ICH S2(R1), which addresses clinical safety data, has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.

The ICH Steering Committee meeting in Seville resulted in several decisions including the approval of a new Q&A document on ICH E10, Clinical Trials Data, and progress updates on various guideline projects related to quality, safety, and efficacy.

The MedDRA Management Board meeting in Seville, November 5-6, 2011, focused on ongoing and future activities related to the maintenance of the Medical Dictionary for Drug Regulatory Activities (MedDRA) terminology.

The International Council for Harmonisation (ICH) has released updated guidance documents to support the implementation of MedDRA (Medical Dictionary for Drug Regulatory Activities) version 14.1, providing clarity and instructions for users.

The International Council for Harmonisation (ICH) has released the Implementation Guide for ICH E2B(R3) on Periodic Protocol Safety Update Reports (PSURs) for consultation, aiming to provide further clarity and facilitate consistent application of the guideline.

The ICH is expanding its collaborative efforts with Africa through increased training, engagement of African regulatory authorities in ICH guideline development, and exploring opportunities for resource sharing to harmonize global standards.