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The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”).  In this blog, we provide an overview of the potential impact of the Proposal

The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products.  In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites.  In this blog

The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.

1. Draft Regulation – Further Clarity Regarding Public Access to Documents

Disclosure of documents in response to an access request under the EU

The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”).  At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use

On 19 December 2022, the parties to the Convention on Biological Diversity (CBD) decided to create a new global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund

The new fund is expected to generate up to 15 billion USD per year, based on contributions from companies that “use

On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application.  The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells.  These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.  Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.Continue Reading European Commission to Harmonize Rules on the use of Substances of Human Origin

On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.Continue Reading EU Plans Ban on Titanium Dioxide in Food

In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions.  This is the case even where the CBD is derived from the whole cannabis plant.  The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union.  This is likely to have wide implications for the CBD industry.
Continue Reading CJEU Confirms that CBD is Not a Narcotic Drug