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Regulatory News | 22 June 2017 | By Nick Paul Taylor
Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
The European Medicines Agency (EMA) has tasked working groups with redistributing regulatory workloads in anticipation of the United Kingdom ceasing to be a member. EMA is ordering the preparations to cut the risk of Brexit disrupting its operations or resulting in the loss of knowledge from the organization.
Today, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) handles a sizable slice of EMA's workload. EMA will lose access to that capacity on 30 March 2019 unless the UK and European Union agree a temporary or permanent agreement that keeps MHRA in the agency. If the clean split goes ahead as anticipated, EMA will need to find additional capacity and expertise from elsewhere to continue providing uninterrupted, unaffected regulatory services.
EMA has put responsibility for laying the groundwork for such a smooth transition on two working groups, one for human medicines, another for veterinary medicines. The tasks facing the groups are similar. EMA expects the groups to distribute the workload for processing of initial marketing authorization applications, scientific advice and pharmacovigilance procedures. The changes to the handling of marketing authorizations include the reassignment of procedures that are yet to start but have been allocated to the UK.
The working groups will figure out how to redistribute this work using responses from surveys EMA is planning to run. EMA wants to conduct the surveys to better understand current and future capacity at the regulatory bodies of member states. This should reveal where gaps exist and whether member states are willing to invest to build out their capabilities.
EMA thinks the best approach to redistributing the regulatory workload will differ between the two sectors, but it wants the groups to work from a shared set of principles.
The top item on the list of principles endorsed by EMA's management board is to "ensure business continuity and proportionality in the distribution of workload." In doing so, the working groups should take the expected date of Brexit in 2019 and the average timelines for different regulatory procedures into account. Other related criteria are that the redistribution must allow EMA to meet legally required timelines and maintain its standards.
EMA's desire to avoid losing knowledge gets its own spot on the list. The agency thinks that could be achieved either by building on existing knowledge or through knowledge transfer. Either way, the goal is to ensure EMA is as equipped to do its work the day after Brexit as it is today. The agency is also looking beyond the Brexit deadline. One objective of the working groups is to distribute the workloads in a way that equips EMA to prosper long after Brexit.
That objective is secondary to the main goal of preventing a disruptive transition. To that end, EMA wants the working groups to develop implementation plans with specific timelines for reassigning work in advance of 30 March 2019. Those plans may include operational changes at EMA.
Human Group, Veterinary Group
MHRA has started a consultation about the impact of human medicines regulations implemented in the UK in 2012. The feedback-gathering exercise is part of a broader initiative to gauge the effect of regulations that aimed to consolidate and simplify decades of British legislation and implement European Union pharmacovigilance requirements.
That broad scope made the regulatory package a landmark moment in the recent history of drug oversight in the UK. The government now wants to know how specific aspects of the regulations have affected the industry and other groups.
One section of the consultation focuses on the pharmacovigilance requirements. MHRA wants to know whether the requirements have been implemented in a way that reduces or adds to burdens. The questions also address how the UK's implementation of the requirements compares to that of other member states and whether changes could reduce the burden the directive places on industry.
The agency is also keen to learn whether the directive had unforeseen consequences, how it has affected patient safety and if it has caused any additional benefits or costs.
Other sections of the consultation document cover changes to cross-border prescriptions and the rights of pharmacies to wholesale without a license. The questions on cross-border prescriptions seek to ascertain what effect the regulations have had on different groups and whether they have caused any difficulties. MHRA has asked similar questions about the changes to pharmacies. This section also addresses the effect on drug supply and the administrative burden to the healthcare service.
The final set of questions covers the effectiveness, consequences and burdens of the consolidation of old regulations.
MHRA is accepting comments until 6 July.
EMA wants to streamline the process patients use to register to contribute to regulatory activities. The agency has initiated the search for a better way to get patients and other groups registered after a survey found dissatisfaction with the current process.
Almost 20% of patients and consumers polled about the level of support they received from EMA rated it as no better than fair. A handful of patients went as far as to class the support they received as poor or very poor. The reasons for these ratings varied, but EMA identified issues with the registration process as a theme running through the comments it received. One patient said the online registration process takes too long.
EMA has responded to the criticism by making the exploration of ways to improve registration one of its goals for this year.
The other improvements proposed by EMA also seek to address points made by respondents. One goal is to "endeavour to send out the documents earlier to allow adequate preparation." Some of the healthcare professionals polled — who on the whole were more positive than patients — said documents arrived too close to meetings for them to have time to prepare.
The Health Products Regulatory Authority (HPRA) of Ireland has published a guide to bringing medical device standalone software to market. The guide covers software that is classed as a medical device and operates independently of hardware.
Medical device standalone software must have a CE mark to come to market in Ireland. The guide covers the steps needed to gain a CE mark, including points of specific relevance to developers of standalone software. The first step is to confirm the product is a medical device.
When doing so, HPRA advises "It is essential that the manufacturer has clearly defined the intended purpose of the software, taking into consideration all of the functions performed by the software."
This means developers of software that performs multiple calculations or features several modules must consider all of them, even if some have non-medical purposes.
The guide also covers conformity assessments, technical documentation, data protection and cybersecurity. On that last point, HPRA advises manufacturers to implement data encryption and authentication mechanisms.
The UK Competition and Markets Authority (CMA) has released the full report on its investigation into the pricing practices of Pfizer and Flynn Pharma. Publication of the report comes six months after CMA fined the companies a total of £90 million ($114 million). CMA Report
Tags: European Regulatory Roundup, Regulatory Roundup