MHRA Outlines Regulatory Goals in Preparation for Leaving the EU
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit.
One of its top priorities is to devise a five-year plan encompassing national and international strategies for collaboration; delivering the agency’s new Patient Safety and Vigilance Strategy, securing global supply chains for medicines and medical devices, and expanding the services provided by the Clinical Practice Research Datalink.
Specific deliverables include chairing the International Coalition of Medicines Regulatory Authorities, and developing relationships with China and India. The agency also plans to establish a working group of European regulators to develop a consistent approach to combination products.
Regarding the use of real-world evidence, the MHRA plans to achieve one ongoing pragmatic clinical trial plus one new study before the end of the year, after expanding the use of the agency’s big data software. Additionally, the agency plans to liaise with the FDA and observe its implementation of the 21st Century Cures Act and real-world evidence initiatives.
In pharmacovigilance, MHRA plans to develop a mobile-friendly reporting website for adverse drug reactions and counterfeited medicines, using a formalized methodology for detecting signals, before the end of the year. The agency is also planning a health summit to discuss safety messages in the healthcare system.
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). Terms of departure are to be negotiated over the coming two years. What will the final outcome look like? Will there be a deal for duty-free movement of goods among nations? Or will punitive tariffs ensue? These are just a few of the questions to which you need answers — ASAP. Tap in the know by ordering the webinar CD/Transcript Brexit and Life Sciences Companies now to plan your next move.