EMA draft guideline

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On 18 November 2022, the European Medicines Agency (EMA) published a draft reflection paper (Paper) for public consultation on the criteria for the evaluation of new active substance (NAS) status for biological substances. The Paper provides guidance for applicants on the elements required for a successful NAS claim, including practical examples and a Q&A. This is an area of significant practical importance for pharmaceutical companies and the Paper is a key element to consider during the development of regulatory strategies for biological, biotechnology-derived and advanced therapy medicinal products (ATMPs).

Chemical active substances are excluded from the scope of the Paper, given they are already addressed in two previous reflection papers. The Paper builds on these reflection papers and provides guidance to applicants based on the EMA’s experience with biological products to date, and the current scientific thinking.

The public consultation on the Paper is open until 31 May 2023.…

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On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.

DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but supplied and obtained separately.…

Continue Reading EMA releases draft guidelines on drug-device combinations