Biologicals

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On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.

The Communication, while directed towards the broader biotech sector, refers to the aim to have a resilient EU biotech ecosystem to safeguard the supply of innovative and generic medicines. It recognizes the significance of vaccine and mRNA technology research for cancer, cardiovascular infectious, and rare diseases, as well as the role of AI in personalized healthcare and diagnostics, including generative AI for medicines discovery and complex genetic diseases.

At the same time, it acknowledges the challenges found in the biotech sector in the EU due to complex regulatory obstacles both nationally and at EU level; or the uncertainty over the return of their investments. Continue Reading Commission Communication on biotechnology and biomanufacturing

On 11 March, the European Commission adopted the proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use: Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024. The amendments will apply from 1 January 2025.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.Continue Reading European Commission proposal to amend the Variation Regulation for Medicines

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.Continue Reading Evaluation of New Active Substance Status for Biological Products in the EU

Earlier this month, the European Commission and representatives of the EU Member States discussed potential revisions to the European Commission’s Note on handling of duplicate marketing authorisation applications (the 2011 Note). According to the information published by the Commission, the discussion took place on 7 November 2019 during the latest Pharmaceutical Committee meeting. The discussion was intended to be focussed on duplicate marketing authorisations for biological medicinal products and the outcome of the related public consultation that took place in 2018.

Background

As we set out in our previous blog, the 2011 Note provides guidance on how the European Commission handles requests for duplicate marketing authorisations submitted through the centralised marketing authorisation procedure in accordance with Article 82.1 of Regulation (EC) No 726/2004 which was motivated by concerns that several MA’s granted for the same product could lead to partitioning of the market. As a general principle, the Regulation contemplates the existence of duplicate marketing authorisations only in two situations; first, where co-marketing with an independent company is envisaged and secondly “where there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients”. In this latter case the Commission has required the applicant to demonstrate that the grant of a duplicate marketing authorisation will result in improved availability of the medicinal product in the EU. The 2011 Note states that, in principle, the grant on “public health” grounds of a duplicate marketing authorisation for a “first generic” granted to an originator (known as an “authorised generic” in the USA) is possible because of its potentially positive impact on the availability of the medicinal product.Continue Reading Update on EU Duplicate Marketing Authorisations