EMA says pharma industry now more prepared for Brexit
pharmafile | September 27, 2018 | News story | Manufacturing and Production, Medical Communications | EMA, EU, brexit, products, qppv
In July of this year the European Medicines Agency (EMA) identified significant gaps in the pharmaceutical industry’s preparedness for Brexit. However, since then much progress has been made, as the number of medicines that it is believed could be subject to disruption has dropped from 108 to 39, according to the European regulator.
“Over the past few months, EMA has made a concerted effort to reach out to the marketing authorisation holders of these 108 centrally authorised medicines to minimise the risk of supply issues for patients,” said Noël Wathion, the EMA’s Deputy Executive Director. “This is a positive development for human and animal health, and, as regards the remaining 39 medicines, we want to take this opportunity to remind the marketing authorisation holders of these medicines to step up their planning now to protect patients and animals from non-supply.”
While in July the EMA held concerns as to the preparedness of 108 marketing authorisation holders in regards to the steps they had made towards implementing changes in preparation for Brexit, such as the relocation of Qualified Persons for Pharmacovigilance (QPPVs), Pharmacovigilance System Master Files (PSMFs) and manufacturing sites; as of now that number has dropped by nearly two thirds as pharma firms have made steps towards preparing for the UK’s exit from the European Union.
In regards to the 39 remaining products, the agency said in a statement that: “For each of the 39 remaining products (25 human medicines and 14 veterinary medicines), EMA is analysing how to minimise supply disruptions and any resulting impact on public and animal health.
The Agency will work directly with the marketing authorisation holders of these products to address the outstanding issues on an ongoing basis. It will also discuss with its scientific committees relevant mitigation measures, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.”
Louis Goss
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s …
