A new regulation just adopted by the Council of the EU will give the UK Medicines and Healthcare products Regulatory Agency (MHRA) responsibility for approving innovative new medicines on a UK-wide basis, making it easier for pharmaceutical companies to market such products in Northern Ireland.
EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.