Latest Regulatory Updates

The ICH E17 guideline on clinical data from exploratory, real-world studies to support drug development has reached Step 2b of the ICH process, indicating that draft guidance is being developed for public consultation.

The ICH Assembly meeting in Lisbon, Portugal, June 2016, resulted in several decisions including the approval of new guidance documents and continued work on existing initiatives related to pharmaceutical quality, safety, and efficacy.

This ICH Q&A document clarifies the processes and requirements for membership and observership within the International Council for Harmonisation (ICH).

The International Council for Harmonisation (ICH) has advanced the ICH S3A Q&As document to Step 2b of the ICH process, indicating further refinement and public consultation are anticipated.

This ICH S1 status report provides an update on the ongoing refinement of regulatory testing paradigms for carcinogenicity in rats, aiming to harmonize approaches and potentially reduce animal use while maintaining patient safety.

The International Council for Harmonisation (ICH) has released training modules 0 to 7 on its website, designed to educate stakeholders on the Q3D guideline regarding elemental impurities in drug products.

The International Council for Harmonisation (ICH) will host an Information Day at the Euro DIA conference in Hamburg to provide updates on ICH initiatives and engage with stakeholders.

The Therapeutic Goods Administration (TGA) of Australia has officially joined ICH as an Observer, signifying increased participation in the development of global technical guidelines for pharmaceuticals.

The ICH E18 guideline on estimating safe starting doses for first-in-human clinical trials has reached Step 2b of the ICH process, indicating that draft elements have been agreed upon and are now open for public consultation.

The International Council for Harmonisation (ICH) has announced that the ICH E14 Q&As (R3) document, providing guidance on clinical evaluation of health products, has reached Step 4 of the ICH process, indicating near finalization and potential adoption by regulatory authorities.

The International Council for Harmonisation (ICH) has announced updates to its application process for new membership and observership, outlining requirements and timelines for interested organizations.

The ICH Assembly meeting in Jacksonville, FL, USA, December 2015, focused on discussions and decisions related to ongoing and future ICH guideline development efforts impacting global pharmaceutical standards.

The International Council for Harmonisation (ICH) has announced changes to its organizational structure, including the establishment of new expert working groups and revisions to existing committee roles, aimed at enhancing efficiency and responsiveness in developing harmonized guidelines.

The ICH M4E(R2) guideline, which addresses questions of mutual recognition for marketing authorization applications, has advanced to Step 2b within the ICH process, indicating public consultation is next.

The ICH E6(R2) Integrated Addendum, which aims to modernize clinical trial standards and address evolving technologies, has advanced to Step 2b of the ICH process, indicating further refinement and stakeholder consultation are underway.

The International Council for Harmonisation (ICH) has released ICH Q3C(R6), revising the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone and establishing a new PDE for Triethylamine to reflect updated toxicological data.

The ICH Steering Committee (SC) in June 2015 made several decisions regarding guideline revisions and new topics, including Q3A(R2), M7, E2C(R2), Q9(R2), and the initiation of work on a new topic related to data integrity.

The ICH M7(R1) Addendum, which addresses genotoxicity assessment, has advanced to Step 2b of the ICH process, signifying public consultation and refinement before potential adoption.

The ICH Steering Committee meeting in Fukuoka, Japan, resulted in decisions regarding the advancement of several guideline projects related to topics including gene therapy and cell therapy quality considerations, control strategies for biotechnological/biological products, and data integrity.

Dawn Ronan has succeeded Odette Morin as the Director of the ICH Secretariat, marking a transition in leadership for the international regulatory harmonization organization.