Brexit is likely to be costly for the European Medicines Agency. Its management board is unhappy the agency was not allowed to use funds from its original 2016 budget to create a “contingency reserve” for dealing with the challenges relating to the departure of the UK from the EU.
The European Medicines Agency’s management board “regrets” that the agency was not permitted to use funds from its original budget for 2016 for a Brexit contingency reserve.
The currently London-based EMA saw its initial 2016 budget cut by €16.3m from €324.7m to €308.4m as a result of...
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The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.
The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
