EU Targets Generics, Inspection Shortfalls & Environmental Assessments
As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.
You may also be interested in...
The adoption of a new common standard opens the way to the implementation of EU-wide electronic formats for documents such as the summary of product characteristics and the patient information leaflet.
New supply arrangements with the two firms are expected to offer greater protection to people in Europe as the autumn/winter season approaches. The EU’s health crisis preparedness body HERA has also identified its “top three health threats.”
A coordinated effort will be needed if Africa is to increase its manufacturing capacity and ensure a market for domestically produced vaccines.