Latest Regulatory Updates

The International Council for Harmonisation (ICH) has advanced the ICH Q7 Quality Risk Management guidance's Question and Answer (Q&A) document to Step 4 of the ICH process, indicating it is nearing completion and intended for release.

ICH has released a new audio presentation to provide further explanation and clarification of the ICH Q3D guideline on genotoxic impurities in drug substances.

The International Council for Harmonisation (ICH) is seeking input from stakeholders to contribute to the development of Q&A documents related to various ICH guidelines, aiming to clarify implementation and address emerging questions.

The International Council for Harmonisation (ICH) will host an Information Day at the Euro DIA conference in Paris to provide updates on ICH's ongoing work and future plans.

The ICH M8 eCTD Implementation Guide has advanced to Step 2b of the ICH process, indicating further refinement and public consultation before potential adoption for electronic submissions.

The International Council for Harmonisation (ICH) has made audio presentations available online to support understanding and implementation of ICH S10, M7, and E2C(R2) guidelines.

The ICH Steering Committee (SC) in November 2014 made several decisions including updates to guidelines on topics such as Q3A(R2), impurity thresholds, and the development of new guidance on data integrity.

The International Council for Harmonisation (ICH) has published frequently asked questions (FAQs) related to ICH E2B(R3), addressing specific points and providing further clarification on the guideline concerning post-approval adverse drug reaction submission.

The ICH Q3D guideline on genotoxic impurities in new drug substances and products has reached Step 4 of the ICH process, indicating it is finalized for adoption by regulatory authorities.

The ICH Steering Committee meeting in Lisbon, November 2014, resulted in decisions regarding ongoing and new initiatives related to technical guidance for pharmaceutical product development and regulatory harmonization.

The ICH Steering Committee (SC) in June 2014 made several decisions regarding ongoing and new projects, including updates to guidelines on topics such as impurities, gene therapy, and risk-based process analytical technology.

The ICH Steering Committee has endorsed the creation of new Expert Working Groups (EWGs) focused on efficacy considerations to advance guideline development in this critical area.

ICH is inviting bids for a contract to provide maintenance and support services for MedDRA, the international medical terminology standard used in drug regulation.

The ICH M7 guideline on cumulative dose assessment of genotoxic impurities has reached Step 4 of the ICH process, indicating it is finalized and ready for adoption by regulatory authorities.

The ICH Steering Committee meeting in Minneapolis, June 2014, resulted in decisions regarding ongoing and new initiatives related to guideline development and refinement across various areas of pharmaceutical quality, safety, and efficacy.

The International Council for Harmonisation (ICH) has published the agenda papers for its upcoming Steering Committee (SC) meeting, which will cover topics related to ongoing and potential new ICH guidelines.

The International Council for Harmonisation (ICH) has published a set of questions and answers (Q&As) to clarify aspects of ICH E2C(R2), which provides guidance on genetic data use in drug development.

The International Council for Harmonisation (ICH) has published additional questions and answers related to guideline E14, which addresses clinical evaluation of health products containing biomarkers.

The ICH Steering Committee (SC) in November 2013 made several decisions regarding guideline revisions and new topics, including Q9(R1), E2C(R2), and the initiation of work on data integrity.

The ICH Information Day at Euro DIA provided updates and facilitated discussions on ongoing ICH initiatives, including guideline revisions and future work plans for stakeholders in the pharmaceutical industry.