Guidance

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On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on  draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).

The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that these highly innovative products can be made available to patients quickly, without compromising any assessment of safety. While the primary focus of the Draft Guideline is individualised messenger Ribonucleic Acid (mRNA) cancer immunotherapies, MHRA suggests that the regulatory and scientific principles considered might be broadly applicable to other disease indications (including rare diseases) or technologies that could benefit from personalisation or individualisation. It also states that the Draft Guideline will be updated when experience of other technologies (peptides, non-integrative DNA and polymer deliver systems) is available.  

In terms of regulatory assessment of individualised mRNA cancer immunotherapies, the Draft Guideline provides clarification of the data which should be included in marketing authorisation (MA) applications and, importantly, confirms that an individualised medicine may, in some circumstances, be granted an MA under the Human Medicines Regulations 2012 (HMRs), even where the product includes an individualised component tailored to the requirements of a specific patient.

There is currently substantial interest in the use of mRNA technology to develop individualised treatments for cancer. The current consultation is therefore of interest to companies focussing on this and other individualised therapies.Continue Reading The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies

On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.

Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.

Applications for the pilot phase are open and will close after 29 October 2023; they can be made via an online application form and associated guidance.Continue Reading UK Government launches Innovative Devices Access Pathway (IDAP)

Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

In December 2020, we posted about the MHRA’s draft guidance on randomised controlled trials generating real-world evidence (RWE) to support regulatory decisions. As we noted in our previous blog, although real-world data (RWD) are widely used to monitor the performance of medicines and devices in patients after regulatory approval, RWD have been utilised much less frequently to demonstrate the safety and efficacy of a product at the stage of initial authorisation. The MHRA aims to provide sponsors with points to consider when planning to conduct clinical trials using RWD sources, and to provide information on the design of studies seeking to generate evidence suitable for supporting regulatory decisions. It is hoped that a greater use of RWD, and more uniform collection and use, will accelerate the availability of cost-effective treatments and reduce the time and cost currently required to generate relevant data.

Following a public consultation on the draft guidance, the MHRA issued its guidance at the end of last year in the form of two papers:

  1. An introduction to the RWD guideline series; and
  2. The first guideline in the series, on planning a prospective randomised controlled trial using RWD sources with the intention of using the trial data to support regulatory decisions.

The intention is for the MHRA to publish further guidelines in the series in due course.Continue Reading Use of Real-World Evidence in the UK

As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).

In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.

After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.

In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland

The day is finally here! Four years after it entered into force, the Medical Devices Regulation (MDR) is applicable today, the 26 May 2021. We have discussed the aspirations and implications of the MDR, we have commented on the slow rate of implementation, and we have heard, and share, some of the frustration expressed by companies as they have prepared for today. From today, industry, regulatory bodies, external advisors and customers will be able to experience the consequences of the radical reform of the medical devices regulatory framework that has been introduced by the MDR.

We have published several blog posts on the key changes and progress of the implementation of the MDR. In this post, now the MDR is officially applicable, we briefly cover where we stand in relation to some of the issues and concerns for the industry. The European Commission recently said that “the 26th of May is not an end date” and we couldn’t agree more. While the MDR was focused on increasing patient safety and the oversight of devices, there is still a lot of work to be done, and there remains a number of outstanding questions. We believe there will need to be a great deal of flexibility by all parties over the coming months in other to avoid disruption for patients.Continue Reading The EU Medical Devices Regulation applies today!

Earlier this month, the European Commission published an updated version of the 2011 Note on the handling of duplicate marketing authorisation applications for medicinal products (the 2011 Note). Following a long period of consultation and exchange with stakeholders and representatives from the EU Member States, the European Commission has sought to clarify the conditions under which applications for duplicate marketing authorisations will be assessed. In this blog post, we discuss the relevant changes, as well as the implications for the industry.
Continue Reading European Commission publishes updated guidance for duplicate marketing authorisations

Although the date of application of the Medical Devices Regulation (MDR) has been delayed by a year, to May 2021, the EU institutions continue to work on its implementation to ensure that the new framework is workable in time for the revised deadline.

In this post, which is part of our series of blog posts covering the implementation of the MDR, we set out a summary of key recent developments. As indicated below, as well as our previous posts, there are several important steps that still need to be taken with regard to MDR implementation. Similarly, many companies are still working on their own compliance. While industry undoubtedly faces a range of challenges in the context of the ongoing health crisis, and the delay provides some welcome breathing room for many, it will nevertheless be important to continue to progress MDR preparedness so that supply is not disrupted.
Continue Reading EU Medical Devices Regulation: implementation progress during the pandemic

On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). It sets out the available regulatory pathways to fast-track assessment of both new or repurposed methods of treating or preventing COVID-19.

Background

This guidance is part of EMA’s efforts to support the development and availability of medicinal products for COVID-19 to address this public health emergency. See also EMA’s guidance on clinical management trials (which we have summarised in a prior Advisory)

This latest guidance is based on the existing and established regulatory procedures to accelerate regulatory review and approval with appropriate adaptations  in direct response to COVID-19 pandemic.
Continue Reading EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19

The EMA and the competent authorities of the EU Member States have issued guidance to manage the conduct of clinical trials and the supply of medicinal products during the COVID-19 pandemic. This Guidance is particularly important for all sponsors conducting studies in the EU and for pharmaceutical companies supplying medicines in the EU. We discuss…