Regulatory Focus™ > News Articles > 2019 > 10 > EU Regulatory Roundup: UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

Posted 17 October 2019 | By Zachary Brennan 

EU Regulatory Roundup: UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

3020 Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup
The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.
Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week. The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases.
To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.
The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.”
Other plans discussed in the briefing document include the implementation of a scheme to stop fake drugs from entering the supply chain, plans to register online retailers and the creation of a framework that supports the updating of legislation. The government wants the ability to update legislation on all aspects of life sciences in response to patient safety issues and changes to the UK’s future global relationships.
The government presented details of the planned bill as part of the Queen’s Speech, which is used to set out the legislative agenda for the upcoming parliament. On this occasion, the Queen’s Speech took place in an unusual context that means it is questionable whether any of the proposed texts will be debated and passed.
As it stands, the government lacks a majority to pass legislation, meaning it would need to rely on the support of opposition parties to bring the Medicines and Medical Devices Bill into law. The likelihood of the current parliament passing the law is further diminished by the fact that observers expect a general election either this year or in 2020. If the government wins the election, it may then make the Medicines and Medical Devices Bill part of its legislative agenda for the next parliament.
Briefing Document
MHRA Shares Guidance on Meeting Post-Authorization Obligations After Brexit
MHRA has updated its guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal. The revised guidance features new sections on post-authorization measures (PAMs) and the implementation of the outcomes of referrals and procedures.
In the PAM section, MHRA details how it will handle post-authorization obligations, such as Annex II conditions, that are in place at the time the UK leaves the EU. These obligations will remain in place and the companies they apply to will need to submit information to MHRA as a post-authorization commitment.
MHRA wants companies to follow the submission principles it set out in the variations section of its guidance on the conversion of centrally authorized products. If data relating to a PAM is being reviewed by regulators at the time of Brexit, MHRA will finish the assessment.
The updated guidance also features a new section on the implementation of the outcomes of referrals and procedures relating to PAMs, periodic safety update reports, post-authorization safety studies and signal assessments. If Brexit happens between a procedure being concluded and a variation being filed, MHRA will implement the outcome using the same mechanism as in the EU.
MHRA added the new sections as part of a revision that also updated existing parts of the text.
The section on signal detection, formerly referred to as signal generation, underwent fairly substantial changes. The revised text states companies must submit “standalone signal notifications submitted to the EMA as well as signals raised by the EMA” to MHRA after Brexit. MHRA will assess signals identified locally and internationally and issue UK decisions. 
MHRA Guidance
Dutch MEB Urges Manufacturers to Update Product Information Faster
The Dutch Medicines Evaluation Board (MEB) has accused manufacturers of taking too long to update product information affected by referrals and periodic safety update single assessments (PSUSA).
MEB monitors when referrals or PSUSA necessitate changes to product information and when the companies involved submit a variation. That experience has shown MEB that the product information remains unchanged for a large number of medicines, leading it to state that companies must make the required updates more quickly.
The notice issued by MEB does not name manufacturers that have failed to make timely updates to their product information but does feature examples of classes of medicine affected by recent referrals and assessments.
MEB lists fluoroquinolones and inhaled corticosteroids for chronic obstructive pulmonary disease among the recent Article 31 referral procedures, which member states and the European Commission use to request scientific reviews of medicines. The Dutch regulator also cited hydrochlorothiazide and paracetamol as product classes affected by recent Pharmacovigilance Risk Assessment Committee recommendations.
MEB Notice (Dutch)
Allergy Therapeutics Vows to Change Website After Rival Complains to MHRA
Allergy Therapeutics has told MHRA it will make changes to a website about living without allergies. MHRA requested the changes after upholding a complaint by Alk-Abelló, a Danish company that competes with Allergy Therapeutics for the allergy immunotherapy market.
Alk-Abelló complained to MHRA on the grounds that a website published by Allergy Therapeutics advertised a prescription-only medicine to the general public. MHRA upheld the complaint.
In response, “Allergy Therapeutics agreed to review the content of their website, reduce the emphasis on the role of immunotherapy for the treatment of allergies and provide a more balanced view of allergy treatment options,” MHRA wrote.
The current website features a page focused on anti-allergic medications such as nasal sprays and antihistamine tablets that was absent from a version that was live last year. Both versions feature a page focused on immunotherapies such as the products sold by Allergy Therapeutics.
MHRA Notice
Other News:
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has named Pirkko Lepola as the new chair of its Coordinating Group. Lepola, who belongs to the Finnish Investigators Network for Pediatric Medicines, will co-chair the Enpr-EMA Coordinating Group for a three-year term. EMA Notice
EMA has tracked a 32% fall in sales of veterinary antibiotics. The decline happened between 2011 and 2017. EMA picked out a 66% decline in sales of polymyxins and a more than 20% drop in sales of third- and fourth-generation cephalosporins as being particularly important given the role they play in the treatment of multidrug-resistant bacteria. EMA Statement
The UK government has entered into agreements with ferry companies to ship medicines after Brexit. The contracts, which are worth up to £86.6 million ($110.2 million), will run for six months to mitigate the risk that disruption created by a no-deal Brexit will stop medicines reaching patients in the UK. MHRA Notice


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Tags: Brexit, EMA, MEB, MHRA

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