The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.
The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.
The EMA is sending its survey directly to companies based in the United Kingdom that hold central EU marketing authorizations for medicines—as well as companies that have their quality control, batch release, import manufacturing sites, or pharmacovigilance operations in the United Kingdom—about their Brexit-related plans. Specifically, the EMA hopes to gain insight into companies’ plans to submit transfers, notifications, or variations to their marketing authorizations.
The EMA says that it hopes that the survey will identify companies in which “…there is a need for concerted action” to ensure the uninterrupted supply of medicines after Brexit and that it can help the EMA and the European Commission plan how to best use their resources in the days ahead. The survey, says the EMA, may also “…serve to stimulate those companies who have not yet taken any action” in planning for Brexit to begin developing and implementing plans.
Concerns about the availability of medicines in the United Kingdom and European Union following Brexit have intensified in recent months; despite recent assurances from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency that there will be no sudden overhauls to UK regulatory frameworks after Brexit, the continued lack of progress on a UK—EU trade deal raises the specter of potential drug shortages.
In November, the European Federation of Pharmaceutical Industries and Associations (EFPIA), an industry group, released the results of its own survey of 43 pharmaceutical companies and 33 national associations, which found that 45% of respondents expect trade delays in the event of a “no deal” Brexit. Currently, 45 million patient-ready packages of medicines are supplied to the European Union from the United Kingdom each month (and the United Kingdom receives 37 million packages each month from the European Union). Any trade delays, according to the EFPIA, could create significant issues for medicine availability.
Pharmaceutical companies will have until February 9 to complete the newly launched EMA survey, and the agency will share its findings and recommendations with the European Commission.
Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans
October 17th 2024Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
October 14th 2024During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.