Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulation

Set Alert for Regulation

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.

Generic Drugs Regulation

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.

Europe Regulation

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.

Regulation Europe

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.

Regulation Europe

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.

Regulation United Kingdom

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.

Europe Regulation
See All
UsernamePublicRestriction

Register