EMA Postpones User Testing Of New e-Application Forms For Variations
A new web-based form is being introduced by the European Medicines Agency to improve the filing and processing of applications for variations to medicines authorized under the EU's centralized procedure. The form will later be extended to nationally approved drugs.
You may also be interested in...
Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”
The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.