Latest Regulatory Updates

The ICH Assembly meeting in Charlotte, NC, USA, November 2018, resulted in decisions regarding the progression of several guideline projects related to topics such as gene therapy and real-world evidence.

The ICH MedDRA Management Committee held a meeting in Charlotte, NC, USA, in November 2018 to discuss and progress various activities related to medical terminology maintenance and standards.

The International Council for Harmonisation (ICH) has released the updated ICH Q3C(R7) guideline and associated support documents, providing revised guidance on impurities in new drug substances.

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH S11 guideline, which addresses nonclinical safety studies for human pharmaceuticals, available on its website for review and feedback.

The International Council for Harmonisation (ICH) has made a presentation associated with the draft ICH M9 guideline on residual solvents, risk assessment available on its website for review and feedback.

The International Council for Harmonisation (ICH) has published Step 2 training material to support the implementation of ICH E9(R1) guideline on estimation of between-subject variability.

The International Council for Harmonisation (ICH) has made a presentation of the draft Q3D(R1) guideline, which addresses impurity qualification, available on their website for review and feedback.

The International Council for Harmonisation (ICH) has published reports detailing the discussions and decisions made during its Assembly and Management Committee meetings held in Kobe, Japan in June 2018, which are now available on the ICH website.

The International Council for Harmonisation (ICH) has published its 2017 Annual Report, detailing the progress and activities of ICH committees related to technical guidelines for pharmaceutical product registration.

The International Council for Harmonisation (ICH) has published a Q&A presentation to clarify aspects of the ICH S9 guideline on control strategies for medicinal products containing biologicals.

The International Council for Harmonisation (ICH) has published Q&A training material related to ICH Q11, providing guidance on developing and manufacturing drug substances.

The ICH M9 guideline on Residual Solvents, which provides updated scientific guidance on acceptable limits for residual solvents in drug substances and products, has reached Step 2b of the ICH process, indicating that draft guidelines are being developed for public consultation.

The ICH MedDRA Management Committee held a meeting in Kobe, Japan, to discuss and progress work related to medical terminology standards for regulatory submissions.

The ICH Assembly meeting in Kobe, Japan, resulted in decisions regarding the advancement of several guideline projects related to pharmaceutical quality, clinical trials, and other areas impacting global regulatory harmonization.

The revised ICH Q3D(R1) guideline on elemental impurities has reached Step 2b of the ICH process, indicating progress towards finalization and potential adoption by regulatory bodies worldwide.

The International Council for Harmonisation (ICH) has moved the ICH S9 Q&As on Control of Excipients in Drug Products to Step 4 of the ICH process, indicating a draft guidance is nearing completion and will soon be released for public consultation.

The International Council for Harmonisation (ICH) has published reports from its Assembly and Management Committee meeting held in Geneva in November 2017, detailing discussions and decisions related to ongoing standards development efforts.

The ICH Assembly meeting in Geneva, Switzerland, November 2017, resulted in decisions regarding the advancement of several guideline projects related to topics including gene therapy and cell therapy, quality risk management, and data integrity.

The ICH MedDRA Management Committee held a meeting in Geneva, Switzerland, to discuss and progress various initiatives related to medical terminology standards for regulatory submissions.

The International Council for Harmonisation (ICH) has made a presentation related to the E18 guideline on control of genetically modified organisms used in manufacturing biological drug substances available on its website.