The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published and updated multiple guidance documents in preparation for changes to the UK@s clinical trial legislation.

Understanding global regulatory guidelines and requirements for chemistry, manufacturing, and controls (CMC) is crucial in developing cellular and gene therapies (CGTs). While the FDA and the EMA ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The 2025 edition of the Chinese Pharmacopoeia (CPh) of the People@s Republic of China includes systematic revisions and improvements across a range of entries. A key aim of the Chinese Pharmacopoeia ...

This article presents a comparative analysis of the regulatory requirements for convenience kits and procedure packs in the US and EU, with an emphasis on classification criteria, labeling and unique ...

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...

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Tweet Deck Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in ...

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This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting ...