RAPS on delayed Brexit26 Mar 2019
The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals.
In an attempt to find a way forward - or perhaps the exit! - in Brexit negotiations, Prime Minister Theresa May has now secured an extension to the 29 March deadline. Paul Brooks, Executive Director, RAPS, comments on recent proceedings.
"Now that Prime Minister Theresa May’s request for a Brexit deadline extension has been granted, it will provide time to make needed preparations. Uncertainty about what will happen after the UK leaves the European Union has been a major concern for regulatory affairs professionals working in pharmaceutical and medical device companies since the day the result of the Brexit referendum was announced in 2016.
"Regulatory professionals provide strategies and guidance to ensure needed healthcare products continue to flow into healthcare systems and are available to patients across Europe. Clarity on how the post-Brexit EU regulatory system and a newly separate UK system will operate relative to one another is urgently needed. Regulatory strategies responding to any change take significant time and resources to implement and need to continuously address clear regulator expectations.
"Unfortunately, now more than 2 years later, many important details remain unclear. Taking additional time to hammer out important points and possibly get a deal in place can only help, but it will be critical to use the extra time productively. In the end, if UK and EU regulations, processes and procedures diverge significantly, or if the two sides fail to agree on some form of mutual recognition, it could lead to duplication of regulatory efforts, most likely resulting in increased costs, time and resourcing for manufacturers, and possibly threatening the availability of current life-saving medicines and medical technology for healthcare providers and patients, as well slowing down access to enhanced or innovative solutions.
"The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals who must guide and advise companies wishing to preserve access to such products. It is one of the major topics we will be examining at the upcoming RAPS Regulatory Conference – Europe 2019, this May in Brussels with separate sessions regarding pharmaceuticals and devices in the post-Brexit era."
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products
18 Jun 2019
Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.Read more
Lessons learned from early EU FMD adopters
13 May 2019
Data exchange, investment costs, resources and hardware identified as some of the biggest challenges.Read more
Brexit's trick or treat on patient safety
29 Apr 2019
Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.Read more
Surge of Indian biosimilars market forecast in 2019
22 Apr 2019
India predicted to be one of the world’s ‘fastest growing bio’ hubs in 2019, fuelled by new biosimilars production.Read more
Sizeable growth potential for global drug delivery and packaging in 2019
19 Mar 2019
Patient-centricity, eco-friendly and smart packaging trends marked as the biggest growth drivers and innovations in 2019.Read more
'Tamper-evident' benefits are evident
28 Feb 2019
2019 will mark Uniplast's debut at this year's edition of CPhI Worlwide in Frankfurt, where it will showcase its expertise in plastic packaging.Read more
All Recipharm facilities ready for EU serialisation, regardless of Brexit
15 Feb 2019
The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.Read more
Brexit - the EU FMD's painful problem
7 Feb 2019
Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.Read more
Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering
27 Jan 2019
New report highlights Germany, France and Switzerland as tier-one nations for ‘drug delivery innovation’, and warns the challenge will be to scale-up and approve promising prototypes.Read more
New API screening program strengthens Particle Sciences' nanomilling offering
22 Jan 2019
Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation