International – ICH releases guidelines on developing medicines for pregnant population and quality information...
The International Council for Harmonisation (ICH) has recently released two draft guidelines for public consultation. One draft guideline focuses on assessing new drugs for...
International – Press Release: ICH Assembly Meeting, Madrid, Spain, May 2025
The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May 2025, in Madrid, Spain in parallel of meetings...
International – International group proposes best practices for AI in pharmacovigilance
The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration...
UK – BMS receives NICE recommendation for immunotherapy combination in colorectal cancer
The health technology assessment agency has recommended in final draft guidance that Opdivo (nivolumab) plus Yervoy (ipilimumab) be used on the NHS in England,...
International – ICH releases overhauled stability guideline for consultation
The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and...
International – Clinical Trials Information System designated as WHO primary registry
The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry Platform (ICTRP). Becoming a...
International – WHO adds first maternal RSV vaccine to prequalification list
The World Health Organization (WHO) has announced that it has added Pfizer’s maternal respiratory syncytial virus (RSV) vaccine to its list of prequalified vaccines.
Abrysvo,...
International – Health agencies recommend best practices for using surrogate endpoints
A consortium of health technology assessment (HTA) agencies has released a white paper that aims to help pharmaceutical manufacturers provide better data on using...
International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
International – ICH adopts E6(R3) guideline on good clinical practices
The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical...
