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EU Regulatory Roundup: UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan

Posted 05 March 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan
The United Kingdom government has detailed what it hopes to get out of its Brexit trade deal talks with the European Union. UK officials are seeking multiple provisions intended to facilitate trade in medicinal products, for example by proposing for each side to recognize good manufacturing practice (GMP) certificates issued by the other.
Unlike the European Commission, which provided scant details of its thinking about medicines and medical devices in its negotiating guidelines, the UK government detailed multiple specific objectives related to the industry in a document outlining its approach to the talks. The UK government wants an annex on medicinal products designed to facilitate cross-border trade and “support high levels of patient safety.”
Specific goals include the aforementioned mutual recognition of GMP certificates. The UK also wants to agree to mutual recognition of batch testing certificates, citing the Comprehensive Economic and Trade Agreement between the EU and Canada as a suitable framework for that part of the deal.
Other parts of the document also look to existing relationships between the EU and other countries for inspiration. If the EU agrees, the reuse of elements of existing agreements could cut the time it takes to strike a deal, thereby helping the UK to hit the tight deadline for completing negotiations.
The other areas in which the UK wants the EU to copy existing agreements include the sharing of confidential information. Agreements between the European Medicines Agency (EMA) and its counterparts in Canada, Switzerland and the United States are in line with the type of arrangement the UK wants to reach with the EU. The UK also wants to cooperate on pharmacovigilance.
UK officials focused their goals for the annex specifically on medicinal products. However, they are open to expanding its scope to “cover procedures relating to vaccines and other biological medicinal products, and clinical trials” in order to “further promote public health.”
The UK outlined its plans for the EU negotiations shortly before publishing a document about planned free trade talks with the US. Reflecting public concerns about the US deal, most of the references to the biopharma industry in that document seek to provide reassurance that the agreement will not affect the price of, or access to, medicines in the UK. The document also reveals that continued alignment with the EU emerged from a survey as the top priority for the biopharma industry.
With the UK government keen to free the country from the constraints it faced as part of the EU, it is unclear if the biopharma industry will get its wish. The government continues to talk up the benefits of leaving the EU, including in a recent debate about the Medicines and Medical Devices Bill that is making its way through parliament.
“This bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world ... all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit,” Matt Hancock, the secretary of state for health and social care, said during a debate about the bill.
Government Document, US FTA, Debate Transcript
EMA Reorganizes, Integrating Human Medicines Operations Into one Division
EMA has changed its organizational structure. The reshuffle sees EMA consolidate its operations involving human medicines into a single division led by its former head of information management, Alexis Nolte.
Nolte’s former division survived the reorganization and kept the same three departments under it, but other parts of EMA no longer exist as independent entities. Previously, aspects of the regulation of human medicines were spread across divisions focused on R&D support, medicine evaluation, and inspections and pharmacovigilance.
None of those three divisions exist anymore. In their place, EMA has established a human medicines division. The new division houses three departments focused on scientific evidence generation, the quality and safety of medicines, and committees and quality assurance.
The changes also affected the veterinary medicines division. That division existed prior to the EMA reorganization, but now features two departments that will cover evaluation and innovation support, and surveillance and regulatory support. Ivo Claassen remains in charge of the division.
EMA disclosed the changes alongside news that it has created four task forces that sit directly under the executive director, as opposed to being part of one of the divisions. The task forces are focused on digital business transformation, data analytics and methods, regulatory science and innovation, and clinical studies and manufacturing.
EMA Statement
Germany Suspends Sartans After Manufacturers Fail to Minimize Risks
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has ordered the suspension of some medicines containing sartans. BfArM took the action against companies that failed to adopt its risk-minimization measures.
German officials told manufacturers to implement its measures or face the suspension of their sartan medicines around the start of the year. Earlier this week, BfArM revealed it had followed through on the threat by sending a letter to the affected drug companies.
The letter disclosed the immediate suspension of the products, provisionally until the start of March 2022. Companies can get the suspension revoked by showing BfArM that they have implemented the requested actions.
BfArM released news of the suspensions shortly before EMA provided an update on its nitrosamine work. The update details the current status of EMA’s investigations, noting that the agency is waiting on results from tests of metformin, but lacks information about new actions taken by the agency.
Such actions may follow the generation and analysis of evidence. In addition to waiting for the data on metformin, EMA is gathering evidence and talking to experts to inform a decision on how to deal with the threat of nitrosamine contamination more broadly.
BfArM Notice, EMA Update
MHRA Issues Notice About Risk of Lacerations From Olympus Duodenoscopes
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice about the risk of lacerations from Olympus duodenoscopes.
Olympus has linked the risk posed by its devices for viewing the small intestine to the presence of frayed elevator wires. In response, Olympus updated its instructions for use to advise healthcare professionals to inspect for frayed elevator wires before and after using the device.
The checks are intended to improve the detection of damage that could cause lacerations. If the checks identify frayed or otherwise damaged elevator wires, MHRA wants users to remove and quarantine the affected devices.
At the time of the publication of a field safety notice in November, Olympus had learned of 12 adverse events linked to the problem. Half of the adverse events involved internal injuries to patients being examined using the device. The other adverse events involved injuries to the fingers of healthcare professionals handling the devices.
MHRA Notice
Other News:
The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued alerts about false CE marking certificates. AEMPS’ alerts, which accuse two companies of using fake CE mark certificates, both involve surgical masks. German health authorities discovered the forgeries and passed the information on to AEMPS. AEMPS Alert, More (both Spanish)

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