The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > 2020 > 10 > Euro Roundup: MHRA to join Project Orbis

Euro Roundup: MHRA to join Project Orbis

Posted 08 October 2020 | By Nick Paul Taylor 

Euro Roundup: MHRA to join Project Orbis

The UK is set to join the US Food and Drug Administration’s (FDA) Project Orbis at the start of next year, Health Secretary Matt Hancock said during a speech on how the UK will approach the licensing of medicines after it leaves the European Union.
FDA set up Project Orbis to facilitate concurrent submission and review of cancer drugs among a pool of international regulators. The US agency worked with its peers in Australia and Canada to review Eisai’s Lenvima in combination with Keytruda last year, marking the first time Project Orbis had been used to support an authorization. Each agency issued its own label after collaboratively reviewing the application.
The UK decided to join the project as the Medicines and Healthcare products Regulatory Agency (MHRA) will lose the ability to collaborate with EU countries on drug assessments next year. MHRA’s participation will potentially accelerate access to some cancer drugs in the UK by allowing companies to gain approval while targeting the far larger US market.
“Since nearly all innovative oncology products are launched in the USA, this new regulatory path may become a key route by which the UK remains an early and priority market for global launches, after the end of the transition period,” said Steve Bates, chief executive officer of the UK Bioindustry Association.
Bates’ comment reflects concerns that UK patients will have to wait longer to access new medicines after Brexit. Currently, companies go through the European Medicines Agency (EMA) to bring drugs to the UK market. As EMA covers one of the world’s largest markets for medicines, it is high on the list of priorities when companies are deciding where to file. After splitting from the EU, the UK may be far lower down the list of priorities.
Debate Transcript, BIA Statement
EMA braces for COVID-19-fueled flood of work
EMA has detailed its preparations for the “unprecedented increase in volume of work” it expects to face after COVID-19 medicines and vaccines come to market. Volumes of post-authorization work are expected to rise sharply as COVID-19 products are given to many millions of people across the EU.
The anticipated surge in post-authorization work will follow a nine-month window, starting in the fourth quarter, in which EMA expects to field a “sharp rise” in marketing authorization applications. In response to the forecast increase in its workload, EMA has invoked its business continuity plan to ensure it has the required capacity. Other activities will suffer because of the shift in focus.
“EMA is already diverting resources away from other important European public health activities, e.g. drafting guidelines for product development,” the agency wrote after a meeting of its management board. “Additional resources are also required for communication activities and engagement with stakeholders on vaccines.”
The management board stressed “that it is critical that extra resources are urgently made available to EMA to allow the Agency to fulfil its public health mandate and respond to patient needs in all disease areas.”
EMA Notice
Ireland’s HPRA proposes fee freeze despite challenging year ahead
Ireland’s Health Products Regulatory Authority (HPRA) has proposed freezing its fees for drugs and medical devices in 2021, despite anticipating that COVID-19 and Brexit will make 2021 “very challenging.”
Next year, HPRA expects to “see the real impact of a hard Brexit” that it now thinks is the most likely outcome, despite ongoing efforts to strike a deal before the end of the year. With payroll costs rising, the regulatory model becoming more complex, and the uncertain impact of COVID-19, HPRA sees Brexit as one of several issues that could drive up spending.
Despite that, HPRA plans to keep its fees the same for 2021. HPRA wants to introduce a new fee for complex classification requests related to novel products and adapt its device fees to the incoming regulations, but most organizations will pay no more to access regulatory services than in 2020.
HPRA proposed the fee freeze in line with the effect of COVID-19 on its finances this year. The closure of HPRA’s offices significantly reduced the agency’s spending on consumables, travel, training and recruitment; a short-term also reduced costs. HPRA wants to pass the savings on to industry in the form of a fee freeze. The proposal is open for comment until the end of October.
Separately, HPRA published an update to its Brexit guidance. HPRA has revised the guidance to take the latest information from the European Commission into account. 
Drug Consultation, Device Consultation, Brexit Guidance
MHRA seeks feedback on post-Brexit regulation of biosimilars
MHRA has released draft guidance on the licensing of biosimilar products after Brexit. The guidance is similar to EMA biosimilar documents but features revisions that reflect more recent experiences.
Officials identified the sections on UK reference products, in vivo animal studies and comparative efficacy studies as areas in which the guidance differs from EMA documents. The MHRA guidance states no in vivo animal studies are requested and that “in most cases” a comparative efficacy trial is not necessary.
Biosimilar developers can choose medicines that have been authorized in the UK for at least eight years as reference products. MHRA will also accept medicines that were on the EU market at the end of the Brexit transition period but never gained a UK product license as the marketing authorization holder opted out of the conversion process.
MHRA is accepting feedback on the draft until 15 November. Once the consultation closes, MHRA will have six weeks to finalize the text before the UK leaves the EU and needs its own system.
MHRA Consultation
Denmark threatens to imprison sponsors who fail to publish clinical trial data
The Danish Medicines Agency (DKMA) has warned sponsors may be imprisoned for up to four months if they fail to publish data from their clinical trials.
Last year, DKMA reported that less than one-quarter of non-commercial sponsors complied with requirements on the publication of clinical trial data. DKMA followed up with warnings to sponsors. The actions have had some effect. Results from 90 clinical trials were overdue at the end of last year. Since then, “several” sponsors have uploaded the missing data, according to DKMA.
Yet, DKMA remains dissatisfied, telling sponsors the situation “is still not good enough.” To encourage greater compliance, DKMA has expressed a willingness to use legal powers to enforce the rules.
Failure to publish clinical trial data on time is punishable by fines and prison terms in Denmark. Faced with persistent offenders, DKMA is willing to work with the public prosecutor to impose the penalties on sponsors that ignore its reminders. 
DKMA Notice
Other News:
EMA has submitted an open letter to European Ombudsman Emily O’Reilly about its handling of the COVID-19 crisis. The letter states EMA is applying its standard independence measures to its work on COVID-19 medicines and vaccines. EMA Notice


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.