Belgium

New updates to 2006 regulations expand the existing framework governing drug shortages in Belgium.

Delegates from European institutions and industry representatives unpacked the many challenges of improved access to critical medicines on the continent in a session at this year’s European Health Forum.

Hyloris’ dispute with AltaThera over the cardiovascular drug Sotalol IV has reached another milestone with a final verdict from an arbitration panel, which cleared Hyloris of financial liabilities while also denying its own claims.

Sanofi CHC names new Italy country manager; Uriach appoints head of France & Belgium; EFSA announces leadership of Scientific Committee.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.

Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.

The aim of the pilot project is to demonstrate that an electronic package leaflet has no negative effects on the proper use of medicinal products in a hospital setting, says the industry body VIG. 

While the introduction of joint clinical assessments under the new EU HTA Regulation could be “fruitful,” the bloc should take a more “integrated approach” to enabling access to ATMPs, according to a Belgian HTA expert.

Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.