This regular update (no. 59 | 16 August 2021) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices...

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new...

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.

The European Commission has started to consider whether Directive 2001/ 20/EC, better known as the Clinical Trials Directive (the Directive), needs to be revised.

The European Commission has authorised a new food health claim recognising the digestive health benefits of green kiwifruit. The claim—"Consumption of green kiwifruit contributes...

On 7 March 2016, the Government submitted to the Chamber of Representatives a bill on the counterfeiting of medical products and similar crimes involving threats to public health.

This regular update (no. 69 | 29 November 2021) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices...

This regular update (no. 81 | 5 April 2022 ) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines...

This regular update (no. 83 | 6 June 2022 ) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices...

On 2 May 2023, the Belgian federal Minister of Social Security and Health published a brief policy document defining three proposed action points to deal with medicine shortages in the EU

On 28 January 2015, in two separate decisions, the European Commission conditionally approved a complex transaction between pharmaceuticals producers GlaxoSmithKline (GSK) and Novartis.

The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.

Following the entry into application of the Clinical Trials Regulation (EU) 536/2014 (CTR) for all initial clinical trial applications on 31 January 2023, the European Medicines Agency...

European Commission approves new and amended Member State measures to support the economy...

On 5 March 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive...

The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.

With formal adoption by both the Council of the EU and the EU Parliament expected by summer 2026, stakeholders should start looking into implementation preparations...

Implementing legislation to enact the United States-Mexico-Canada Agreement (USMCA) is expected to be introduced as early as the week of 16 December following extensive discussions...

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union ("Council") and the European Commission...