Europe: Food, Drugs, Healthcare, Life Sciences

Belgium introduces significant reforms to pharmaceutical law through the Act of 30 May 2026, addressing critical medicine shortages through enhanced export controls and stock allocation measures. The legislation also modernizes the Federal Agency for Medicines and Health Products' operational framework and adapts clinical trial regulations to support decentralized research models.

The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin

An investigation is underway after multiple sclerosis patients in the UK reported adverse effects following a switch from the originator medicine Tysabri to its biosimilar Tyruko. Despite regulatory approval confirming no clinically meaningful differences between the two natalizumab-based treatments, subtle variations in manufacturing processes, formulation buffers, and molecular characteristics may explain why some patients have experienced worsening symptoms or side effects.

L’arrêt rendu le 29 avril 2026 par le Tribunal administratif fédéral suisse (TAF) dans l'affaire B-6574/2025 (CF & C Finance Suisse SA et Swiss DermaCosmetics SA contre Mossad Abounahi...

A new report from ITU, WHO, and WIPO reveals how AI-health innovators can transform breakthrough technologies into scalable healthcare solutions through integrated intellectual property strategies. The guidance explores the intersection of patents, trade secrets, regulatory approvals, and data governance in building commercially viable AI-enabled medical innovations.

Belgium introduces significant reforms to pharmaceutical law through the Act of 30 May 2026, addressing critical medicine shortages through enhanced export controls and stock allocation measures. The legislation also modernizes the Federal Agency for Medicines and Health Products' operational framework and adapts clinical trial regulations to support decentralized research models.

The Regulation on Aromatherapeutic Products (the "Regulation"), published in the Official Gazette dated 2 July 2026 and numbered 33298, establishes, for the first time, a comprehensive regulatory framework governing the authorisation, manufacture, importation, packaging, distribution, placing on the market and supervision of aromatherapeutic products.

L’arrêt rendu le 29 avril 2026 par le Tribunal administratif fédéral suisse (TAF) dans l'affaire B-6574/2025 (CF & C Finance Suisse SA et Swiss DermaCosmetics SA contre Mossad Abounahi...

2 Temmuz 2026 tarihli ve 33298 sayılı Resmî Gazete'de yayımlanan Aromaterapötik Ürünler Hakkında Yönetmelik (“Yönetmelik”) ile aromaterapötik ürünlerin ruhsatlandırılması, üretimi, ithalatı, ambalajlanması, dağıtımı, piyasaya arzı ve denetimine ilişkin usul ve esaslar ilk kez kapsamlı şekilde düzenlenmiştir.