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Posted 31 August 2017 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The United Kingdom life sciences industry has asked the government to prioritize maintaining close ties to regulators in Europe as it shapes the post-Brexit landscape. Offered the choice between seizing potential regulatory flexibilities created by splitting from the European Union and trying to maintain something like the status quo, industry leaders have opted for the latter.
Industry leaders shared their views in a government-commissioned report authored by University of Oxford professor John Bell. The report details what the industry wants to achieve over the next decade and how the government can help. These requests will influence the deal the life sciences industry plans to strike with the government. If the industry gets its way, the requests will also guide the government’s approach to multiple aspects of the Brexit process.
Some of the requests deal directly with regulations. As Bell notes in the report, some people have talked up the prospect of the UK using its split from the EU to create a more innovative regulatory system that is faster to approve emerging technologies. This thinking is guiding by a belief the UK Medicines and Healthcare Products Regulatory Agency (MHRA) is more progressive than many of its European peers and can go further still when freed from the region-wide regulatory structure.
The sector report pours cold water on this idea while delivering a frank reminder of the status the UK will have if it opts to completely divorce itself from the European Medicines Agency (EMA).
“While this innovative strand in the MHRA approach might be theoretically desirable from a UK life sciences ecosystem point of view, it would only be additive if it did not jeopardise the UK’s participation in the EU systems and processes,” Bell wrote. “Relatively speaking, the UK market is too small even with the fastest and most innovative regulatory system in the world, to stand alone from a larger decision-making bloc.”
If enacting regulatory policies that diverge from those in place in the EU forces the UK to loosen its ties to EMA, the life sciences sector thinks the benefits are unlikely to outweigh the costs. As such, the report argues the UK should focus on ensuring a degree of harmonization with the EU before looking for opportunities to adopt innovative approaches.
Arguing the UK market is too small to make a wholly free-standing system efficient, the report calls for MHRA to remain involved with the review of dossiers and scientific deliberations by EMA. The UK could then make its own decision based on the shared information if the government wants to exclude the country from the EU voting system. This proposal seeks to enable the UK to continue to benefit from the harmonized, EU-wide regulatory machinery without causing a backlash by the newspapers and voters who saw Brexit as a chance to “take back control.”
The report advocates for the UK to continue working closely with the EU on clinical trials, pharmacovigilance and any other area in which having access to data on large numbers of patients will improve decision making. Bell also argues the UK should remain part of the CE-mark system for approving medical devices, which is already used in non-EU countries such as Norway and Turkey.
These Brexit-related considerations account for the bulk of the regulatory recommendations made in the paper, but other sections also touch on the role of MHRA. The report’s non-Brexit recommendations include the suggestion MHRA and the National Institute for Health and Care Excellence should independently process assessments in parallel.
EMA is asking former marketing authorization holders (MAHs) to continue collecting spontaneous reports of suspected adverse reactions after their products are pulled from the market. The agency thinks this continued vigilance will support the review of delayed-onset adverse reactions.
Regulatory officials outlined their stance on the responsibilities of MAHs that have their marketing authorizations withdrawn, revoked or not reviewed in its post-authorization advice document. The stance adopted by EMA falls short of demanding ex-MAHs collect adverse event reports, but makes it clear the agency sees value in continuing to monitor patients who took now-withdrawn drugs.
The agency may go a step further in some “exceptional cases” by asking the former MAH to file a final periodic safety update report (PSUR). This would entail EMA and the MAH agreeing on the procedural details of the PSUR submission. The PSUR would not be subject to a single PSUR assessment and, as such, would not go into the PSUR repository.
EMA also used the update to the advice document to address how the withdrawal of a product affects the ongoing single PSUR assessment. The assessment will continue if it includes marketing authorizations that are still valid or there are other, still-sold drugs with the same active ingredient as the withdrawn product. In all other cases the procedure will stop.
The other question added to the document in the latest revision addresses what companies must consider if there are changes to their medical devices after authorization. EMA also revised its answers to other questions about topics including re-assessment applications and mock-ups.
EMA has added a significant section on medical devices to its pre-authorization advice for users of the centralized procedure. The update covers how the two outgoing medical device directives and rules on medicines apply to products that blur the lines between these categories.
The new section starts with an introduction to the directives on active implants and all other types of device — which will be replaced by the recently adopted regulation — before addressing three specific questions about how these texts apply to certain types of product.
EMA covers when a device and medicine are considered a single integral product, when a drug delivery product is regulated as a medical device and details regarding marketing authorization applications that contain a medical device. In each case, EMA clarifies which regulations apply to the products and what this means for the sponsors seeking to bring them to market.
The revised document also features a new section on when it is acceptable to use the centralized procedure for packages that contain multiple active substances in separate dosage forms. These combination packs can only come to market under a single, centralized marketing authorization if there is a compelling public health reason. EMA will refuse applications for packs that combine drugs for convenience or commercial purposes.
Stéphane Rossini has been named as president of the Institute Council of Swissmedic. Rossini will take up the position on 1 January 2018, ending Christine Beerli’s 12-year stint in the job. The change at the top follows a decision to gradually revise the membership of the Swissmedic council. Rossini will serve a three-year term. Swissmedic Statement (French)
Novo Nordisk is recalling certain batches of its NovoPen Echo and NovoPen 5 from the UK. The action follows the discovery of cracks in the cartridge holders of some products that may result in the under delivery of insulin. News of the recall comes almost two months after Novo Nordisk withdrew some batches of NovoPen Echo from the United States. MHRA Notice
Tags: Brexit, medical device directives, PSUR
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