LATEST ARTICLES
Belgium
Altius
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of "negative formulations" on the packaging...
Cooley LLP
Ten medical device and IVD developers will receive free advice on their clinical development strategies from medical device expert panels.
Crowell & Moring
The Belgian regulatory framework for medical devices is highly complex, and the already dense legal landscape was recently added to by the adoption of two new Belgian royal decrees...
Innovation Park
Belgium's biotech industry is well-established. The country has long supported advancements in life sciences and biotechnology.
Arnold & Porter
On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice).
European Union
Cooley LLP
The European Commission has adopted Commission Delegated Directive (EU) 2023/1526, which amends Directive 2011/65/EU of the European Parliament and European Council...
Cooley LLP
On 12 July 2023, the European Commission published a factsheet for authorities outside the European Union (EU) and the European Economic Area (EEA)...
Van Bael & Bellis
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
Cooley LLP
In the EU, medicinal products, medical devices, food supplements and cosmetics are governed by distinctive legislative frameworks.
Timelex
On May 3, 2022 the European Commission released a proposal of the European Parliament and of the Council for a European Health Data Space Regulation.
Cooley LLP
The extension of the transitional periods in the MDR and the removal of the "sell-off" deadline in the MDR and the IVDR were approved by the Council of the EU today.
Cooley LLP
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...
Cooley LLP
The European Commission has adopted a draft implementing regulation that will up-classify certain products without a medical purpose that nevertheless fall within the scope...
Cooley LLP
The EU Medical devices Regulation Cooley's Productwise Bitesize brings you a short overview of the EU Medical Devices Regulation.
Cooley LLP
On 14 January 2022, the European Commission published a draft Implementing Regulation laying down the Common Specifications for the groups of products without an intended medical purpose...
Cooley LLP
Cooley's Productwise Bitesize brings you a short overview of the transitional provisions in the new Clinical Trials Regulation.
Hogan Lovells
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
Hogan Lovells
The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.
Hogan Lovells
Shortly after updating the related draft Questions and Answers document, the European Commission has published two new...
Hogan Lovells
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
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