Latest Regulatory Updates
516 articles from official regulatory sources
The reports of the ICH MC and Assembly Virtual meetings in May 2020 available now on the ICH Website
Reports detailing the discussions and decisions made during the International Council for Harmonisation (ICH) Management Committee (MC) and Assembly virtual meetings in May 2020 are now available on the ICH website.
The ICH M7 Q&A draft document presentation available now on the ICH website
The International Council for Harmonisation (ICH) has made a draft Q&A document related to ICH M7 guideline on genotoxic impurities available for review and feedback on the ICH website.
The International Council for Harmonisation (ICH) has published a Q&A document and its support document related to guideline M7, providing further clarification on genotoxic impurities in drug substances.
The ICH S5(R3) introductory training presentation including a voice over available now on the ICH website
The International Council for Harmonisation (ICH) has released an introductory training presentation, including a voice-over, to explain the updated ICH S5(R3) guideline on mutagenicity testing of genotoxic impurities in drug substances.
The International Council for Harmonisation (ICH) has moved the eCTD v4.0 Q&A v1.3 document to Step 4 of the ICH process, indicating it is nearing completion and potential adoption as a standard.
The ICH Assembly held a virtual meeting in May 2020, discussing progress on various guideline developments and strategic priorities related to pharmaceutical quality, safety, and efficacy.
Summary of the E6(3) Stakeholder Engagement Approach available now on the ICH website
This announcement details the approach ICH has taken to engage stakeholders during the development of E6(3) guidelines, which focuses on clinical trial standards and aims to ensure patient involvement and transparency.
The International Council for Harmonisation (ICH) has launched a series of videos on the ICH website, titled "ICH Perspectives," to provide insights into ICH's work and processes.
The ICH S11 guideline, Development and Use of Nonclinical Safety Pharmacology Data for Drug Risk Assessment, has reached Step 4 of the ICH process, indicating it is available for adoption by regulatory authorities.
The International Council for Harmonisation (ICH) has published a notification detailing updated MedDRA terms related to coronavirus concepts, intended for use in regulatory submissions and adverse event reporting.
The International Council for Harmonisation (ICH) has released a draft revision (R8) of the Q3C guideline, which addresses impurities in new drug substances, available for public review and comment on the ICH website.
The International Council for Harmonisation (ICH) announced the cancellation of its Vancouver meeting scheduled for May 2020 due to travel restrictions and safety concerns related to the COVID-19 pandemic.
The ICH M9 introductory training presentation available now on the ICH website
The International Council for Harmonisation (ICH) has made an introductory training presentation on ICH M9 (Quality Risk Management) available on its website to facilitate understanding and implementation of the guideline.
The ICH S5(R3) introductory training presentation available now on the ICH website
The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH S5(R3), providing guidance on the generation of additional pharmacokinetic data to support clinical assessment of potentially carcinogenic substances.
Summary report of the ICH Global Meeting on E8(R1) available now on the ICH website
A summary report detailing discussions and outcomes from the ICH Global Meeting on E8(R1) (Revised) - General Considerations for Clinical Trials of Therapeutic Proteins is now available on the ICH website, focusing on updates to guidance related to clinical trial design.
The ICH Q12 introductory training presentation available now on the ICH website
The International Council for Harmonisation (ICH) has published an introductory training presentation on ICH Q12, providing guidance on quality considerations for technical pharmaceutical product registration.
ICH S5(R3), concerning guidelines for nonclinical safety studies in support of human pharmaceuticals, has reached Step 4 of the ICH process, indicating it is finalized and ready for adoption by regulatory authorities.
The minutes of the ICH Assembly meeting in Singapore, in November 2019, available now on the ICH Website
The International Council for Harmonisation (ICH) has published the minutes from its Assembly meeting held in Singapore in November 2019, detailing discussions and decisions made by member organizations.
The minutes of the ICH MC meeting in Singapore, in November 2019, available now on the ICH Website
The International Council for Harmonisation (ICH) has published the minutes from its Management Committee meeting held in Singapore in November 2019, detailing discussions and decisions made by the committee.