Latest Regulatory Updates

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.

The International Council for Harmonisation (ICH) has released finalised and draft guidelines, alongside publishing the membership of its working parties for the first time, to advance harmonized regulatory standards across multiple regions.

The International Council for Harmonisation (ICH) has made a presentation related to the draft ICH S5(R3) guideline on quality of multi-source drug substances available on its website, inviting stakeholders to review and provide feedback.

The International Council for Harmonisation (ICH) announced confirmed meeting schedules for several working groups during the upcoming ICH meeting in Geneva, focusing on ongoing standards development initiatives.

The ICH is launching two new training pilot programmes focused on the Q12 guideline for Pharmaceutical Product Quality System and the M10 guideline for Analytical Procedures, designed to enhance understanding and implementation of these standards within the industry.

The International Council for Harmonisation (ICH) has published reports from its Assembly and Management Committee meetings held in Montreal, May/June 2017, detailing discussions and progress on various guideline development initiatives.

The ICH E11(R1) Addendum, which provides updated guidance on clinical trials for non-inferiority or equivalence studies, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory bodies.

The ICH E18 guideline on base-line clinical data has reached Step 4 of the ICH process, indicating it is finalized and ready for adoption by regulatory authorities worldwide.

The ICH Q11 Questions & Answers document has reached Step 4 of the ICH process, indicating it is nearing completion and potential adoption by regulatory bodies worldwide.

The ICH S5(R3) revised guideline on quantitative assessment of drug substance impurities has reached Step 2b in the ICH process, indicating it is now open for public consultation and further refinement.

The ICH E9(R1) Addendum, which provides additional guidance on estimating the exposure-response relationship for dose selection in clinical trials, has advanced to Step 2b of the ICH process, indicating further public consultation and refinement are planned.

The International Council for Harmonisation (ICH) has launched pilot training programmes focused on ICH guidelines to enhance understanding and implementation across various regions.

The International Council for Harmonisation (ICH) is developing a new guideline, E19, focused on optimizing the collection of safety data during clinical trials to enhance patient safety and improve drug development efficiency.

The International Council for Harmonisation (ICH) has published revised versions of its Articles of Association, Rules of Procedure, and Standard Operating Procedures, which are now available on the ICH website to ensure continued operational effectiveness.

The ICH M7(R1) Addendum, which provides additional guidance on genotoxic impurities in drug substances and products, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory bodies.

The ICH Assembly held a meeting in Montreal, Canada in May/June 2017 to discuss and advance various topics related to technical harmonization for pharmaceutical product registration.

The ICH MedDRA Management Board held a meeting in Montreal, Canada, discussing ongoing and future maintenance of the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

The International Council for Harmonisation (ICH) announced the confirmed working groups that will convene during their upcoming meeting in Montreal to progress ongoing standards development initiatives.