International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
Europe – EMA Management Board: highlights of March 2024 meeting
EMA annual report 2023
The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which...
USA – FDA offers guidance on minor label changes for OTC drugs
The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance...
UK – Guidance published on the new international regulatory recognition routes for medicines approvals
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how...
Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
USA – FDA revises final guidance on nitrosamine impurities
The US Food and Drug Administration (FDA) on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in...
USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and...
USA – FDA moving in the right direction with psychedelic drug guidance
The US Food and Drug Administration’s (FDA) recent guidance on psychedelic drug development is a “policy landmark” and a step in the right direction...
International – ICH charts new topics, touts progress in updating existing guidelines
The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for...
