Latest Regulatory Updates

ICH Q11, which addresses Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), has advanced to Step 2 of the ICH process, signifying public consultation on a draft guidance document.

The ICH Steering Committee meeting in Cincinnati resulted in several key decisions, including advancing the Q3A(R2) guideline on CTMP impurity assessment and initiating a new project to develop guidelines for data sharing in clinical trials.

The MedDRA Management Board meeting in Cincinnati resulted in decisions regarding the maintenance and enhancement of the MedDRA coding dictionary, including updates to adverse event terms and related activities for standardized medical terminology.

This announcement provides a detailed record of the discussions that occurred during the ICH GCG meeting in November 2010, focusing on various topics related to guideline development and international harmonization.

This article commemorates the 20th anniversary of the International Council for Harmonisation (ICH), highlighting its evolution, achievements in harmonizing technical requirements for pharmaceuticals across regions, and outlining future directions for standards development.

The International Council for Harmonisation (ICH) will host a regional public meeting in the US on September 26-27, 2024, to discuss ongoing and future ICH initiatives and solicit feedback from stakeholders.

The ICH Quality Interest Working Group (Q-IWG) has developed training materials to support understanding and implementation of ICH guidelines Q8, Q9, and Q10 related to pharmaceutical quality systems.

This announcement details the key decisions made by the ICH governing body in November 2010, covering topics such as Q3A(R2) impurity guidance, Q9 quality risk management, and other ongoing initiatives related to harmonized technical requirements for pharmaceuticals.

The International Council for Harmonisation (ICH) has released a revised Pharmaceutical Development Excipient (PDE) for Cumene, updating ICH Q3C(R5) to reflect current scientific understanding and industry practices.

The International Council for Harmonisation (ICH) has announced a new guideline, E2C(R2), which will replace the existing E2C(R1) guideline on genetic and analytical characterization of substances for pharmaceutical quality.

The International Council for Harmonisation (ICH) is marking its 20th anniversary with a new visual identity to reflect the organization's ongoing evolution and commitment to harmonization of technical requirements for pharmaceuticals.

The International Council for Harmonisation (ICH) is expanding its engagement with non-ICH regions to foster greater alignment and adoption of ICH guidelines globally.

Health Canada now formally recognizes all ICH Q4B pharmacopoeial texts, aligning its regulatory approach with international standards for pharmaceutical quality.

The International Council for Harmonisation (ICH) has released updated MedDRA guidance alongside the release of MedDRA version 13.1, providing revisions and clarifications to terminology used in adverse event reporting.

The ICH Steering Committee held its 61st meeting and made decisions regarding the advancement of several guideline projects, including those related to mRNA vaccines, continuous manufacturing, and data integrity.

The International Council for Harmonisation (ICH) has released several newly updated and finalized guidelines addressing topics including quality risk management, impurity qualification, statistical principles for clinical trials, and good pharmacovigilance practice.