Articles

Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023: the amendments to the Food Safety Agency’s administrative fining regime, the introduction of nutrivigilance, and the announced revision of the food hygiene legislation.

The Clinical Trials Regulation (CTR), effective from January 31, 2022, introduced a pivotal change in the EU’s clinical trial landscape. Transitioning from the previous Clinical Trial Directive (CTD) to the CTR involves submitting a streamlined “transitioning application” before January 30, 2025. This regulatory evolution underscores efficiency and transparency in clinical trials, urging sponsors to initiate the transition process promptly for uninterrupted trial continuity under the CTR.

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.

Despite many initiatives by the (former) Minister of Health, the uptake of biosimilars in Belgium has remained rather low. In this blog, we summarise the new rules, which apply since 2 October 2023. 

Global pharmaceutical industry has become the field for serious patent-related battles between producers of original drugs and manufacturers of generics.

Particularly this trend is widely observed in EAEU and CIS, where the regulatory bodies and courts have not yet developed an efficient mechanism for maintaining the balance of interests between the pharmaceutical businesses, state and patients.

Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies in EAEU and CIS, Lidings publishes Legal Digest highlighting the most notable patents disputes in Life Sciences that have been recently taking place in those jurisdictions.