Starting 1 January 2026, the Belgian Federal Agency for Medicines and Health Products (“AFMPS”) will implement accelerated evaluation timelines for initial applications for clinical trials involving medicines for human use....more
On 10 September 2025, the Belgian Competition Authority (the BCA) published a communication clarifying the conditions under which pharmaceutical companies may exchange information specifically in the context of reimbursement...more
On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products. ...more
On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human...more
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more
On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more