The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.
The European Commission’s proposals for revising the general EU pharmaceutical legislation, which were published on 26 April, have now been sent to the European Parliament and the Council of the EU, which are preparing to scrutinize them under the ordinary legislative procedure – formerly called the “co-decision” procedure.
The proposals are in the form of a draft regulation and a draft directive that will repeal or amend several...
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.
Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.
