On 18 December 2024, the European Commission published a proposed implementing regulation relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU (“Proposal”), which will update European Commission Implementing Regulation (EU) 520/2012 (“Implementing Regulation”). While the core PV requirements, including the obligation to establish and operate a PV system and the key reporting
The Secretariat of the Convention on Biological Diversity (CBD) has opened four consultations inviting stakeholder input on the development of the new Multilateral Mechanism on Benefit-Sharing (MLM) for Digital Sequence Information (DSI), including the establishment of the global benefit-sharing fund known as “The Cali Fund.”
Companies are encouraged to actively participate in these consultations
In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework. From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective. The new measures
In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court of Justice (“ECJ”) for a
The European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal. The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the EU. Member States must implement
Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).
On 14 November 2024, the MHRA
The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the
In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover,
On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here). Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Deon Govender discuss Regulatory and policy developments from South Africa: SAHPRA’s proposed Black Economic Empowerment (BEE) policy and its potential impact on license holders for medicines and medical devices