Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

EU member states have agreed to routinely use a flexible process that can facilitate the use of multilingual packaging for prescription-only medicines.

The European Medicines Agency has issued draft recommendations on how vaccine developers can generate efficacy data to enable their product’s safe use in immunocompromised individuals.

EU regulators say they have tackled many of the concerns raised by study sponsors in two surveys regarding the implementation of the EU Clinical Trials Regulation and are now focused on addressing the five “most critical remaining challenges.”

A UK-based CRO specializing in human challenge trials says there is a big shift in industry sentiment towards such studies. Companies targeting infectious diseases are now actively accommodating challenge trials in their development plans instead of needing persuasion.

Swedish regulator Ulla Wändel Liminga, the incoming chair of the European Medicines Agency’s Pharmacovigilance Committee, will oversee a number of projects including those she was already with such as those related to the safety of medicines during pregnancy and breastfeeding.