Latest Regulatory Updates

The ICH M9 guideline on Pharmaceutical Quality Lifecycle Strategy and its associated Q&As have reached Step 4 of the ICH process, indicating they are available for adoption by regulatory authorities.

The ICH Q12 guideline on quality considerations for technical pharmaceutical product lifecycle management and its associated annexes have reached Step 4 of the ICH process, indicating near completion and potential adoption by regulatory bodies.

The ICH E9(R1) Addendum, which provides additional guidance on estimating the population parameters for clinical trials, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory bodies.

The ICH Assembly meeting in Singapore, November 2019, resulted in decisions regarding the progress of various guideline developments and strategic initiatives related to pharmaceutical quality, safety, and efficacy.

The International Council for Harmonisation (ICH) has published a report detailing the findings of its 2019 implementation survey, assessing adherence to ICH guidelines by regulatory authorities and pharmaceutical industries globally.

The ICH Q3C(R6) guideline, which addresses impurities in new drug substances, has been reinstated and is now available on the ICH website for use by pharmaceutical companies.

The International Council for Harmonisation (ICH) has published training materials to support the implementation of the ICH E17 guideline on fertility assessments for anti-reproductive medicines.

The International Council for Harmonisation (ICH) will host a global meeting to discuss and progress the E8(R1) guideline on general considerations for clinical trials, aiming to refine and update the existing standards.

The International Council for Harmonisation (ICH) has published the minutes from its Assembly meeting held in Amsterdam, Netherlands, in June 2019, detailing discussions and decisions made regarding ongoing harmonization efforts.

The International Council for Harmonisation (ICH) is holding a public stakeholder meeting to discuss revisions to the E8(R1) guideline on general considerations for clinical studies, focusing on statistical principles and data analysis.

The ICH MedDRA Management Committee held a meeting in Amsterdam, Netherlands, to discuss and progress various maintenance and enhancement activities related to the Medical Dictionary for Drug Regulatory Affairs (MedDRA).

The ICH Assembly meeting in Amsterdam resulted in decisions regarding ongoing and new initiatives, including the approval of a concept paper on Real-World Evidence for Clinical Trial Outcome Assessment.

The International Council for Harmonisation (ICH) has made a presentation associated with the draft ICH E8(R1) Guideline available on its website, focusing on general considerations for clinical data to support drug development.

The ICH E8(R1) guideline, which provides updated guidance on the statistical principles for clinical trials, has advanced to Step 2b of the ICH process, indicating that draft material is available for public consultation.

The International Council for Harmonisation (ICH) is seeking expressions of interest from qualified individuals to serve as ICH Training Associates, supporting the development and delivery of training programs related to ICH guidelines.

The ICH Q3D(R1) guideline on elemental impurities has reached Step 4 of the ICH process, indicating it is finalized and ready for adoption by regulatory authorities worldwide.

The International Council for Harmonisation (ICH) has published a draft guideline M10 on the requirements for registration dossiers and a related presentation, seeking stakeholder feedback to refine the guidance on regulatory submission formats.

The International Council for Harmonisation (ICH) has published the minutes from its Medical Committee meeting held in Charlotte, NC, USA, in November 2018, detailing discussions and decisions related to ongoing ICH guidelines.

The International Council for Harmonisation (ICH) has released a reflection paper exploring further opportunities to harmonize standards for generic drug quality, aiming to improve efficiency and consistency across regions.

The International Council for Harmonisation (ICH) has published the minutes from its Assembly meeting held in Charlotte, NC, USA, in November 2018, detailing discussions and decisions made by member organizations.