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US Generics Approvals Will Decline
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
Harmonization Needed For Complex And Value-Added Drugs
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.
Regulatory Measures Could Mitigate EU Coronavirus Risks
As part of its response to the coronavirus outbreak, Medicines for Europe has set out a series of policy recommendations that it says could help to mitigate the risks of COVID-19.
Globalized Approach Is Critical To Regulation
Regulatory processes need to be optimized and must reflect increasing globalization, heard delegates to Medicines for Europe’s 2020 Regulatory & Scientific Affairs conference. Digital technologies are part of the solution.
UK's MHRA Looks Beyond Brexit Transition Period
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.
EU Parliament Urges Post-Brexit Cooperation
Life science companies will be pleased to hear that the European Parliament is pressing for close cooperation between the UK and the EU in the area of medicines regulation.
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