Regulatory Flexibilities Help Ease EU Amoxicillin Shortages
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.
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New French Body To Lead Efforts Against Drug Shortages
A new committee including representatives of the French pharma industry, health professionals and patients is to lay the groundwork for a longer-term approach to preventing and managing medicine supply chain issues. A separate initiative launched by the prime minister will look at medicines access issues and strengthening the French manufacturing base.
EU Sets New Date For Publication Of Delayed Pharma Revision Proposals
Lengthy legislative procedures are expected after the commission publishes its “pharma package” and the “patent package,” which are now due towards the end of April.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.