On 4 January 2022, after approximately four years from the UK government’s first attempt to reform the UK national security screening regime, the National Security and Investment Act 2021 (NSIA) became operational. The NSIA represents a radical overhaul to investment screening in the UK as it introduces for the first time a mandatory and suspensory filing obligation for transactions in 17 sectors considered as particularly sensitive (among which are Synthetic Biology and Artificial Intelligence).

Alongside a mandatory and suspensory regime for certain transactions, parties are also encouraged to notify transactions voluntarily if—regardless of the sector concerned—the transaction might have national security implications based on (i) nature/identity of the acquirer, (ii) target’s activities, and/or (iii) nature and degree of control acquired. Unlike the mandatory filing obligation which only captures acquisition of entities, the voluntary regime also captures the acquisition of tangible and intangible assets—thereby including the acquisition, assignment and/or licensing of IP rights over e.g. molecules, compounds, methods or technologies.

Continue Reading The UK National Security and Investment Act 2021 (NSIA) – Implications for Life Sciences

As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland.

Continue Reading The EU IVDR is here!

In December 2020, we posted about the MHRA’s draft guidance on randomised controlled trials generating real-world evidence (RWE) to support regulatory decisions.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

Earlier this month, the European Commission published a proposal for a Regulation for the European Health Data Space (EHDS) aimed at regulating and facilitating electronic health data access and sharing across the European Union (the Proposal). The two main objectives of the EHDS are to (i) enable individuals to easily access and control their electronic health data; and (ii) allow researchers, innovators and policy makers to use electronic health data in a lawful, legitimate, trusted and secure way that preserves privacy and the fundamental rights of patients. Continue Reading EU Digital Health Policy: European Commission launches European Health Data Space

On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.

Continue Reading Harmonisation of international rules on medical device quality management systems

On 31 March 2022, the Food Standards Agency (FSA) published the list of cannabinoid (CBD) containing food products that have a credible application for novel food authorisation pending with the FSA.

The products on the list may remain on the market in England and Wales while their application is considered.  For CBD products not on the list, FSA advises local authorities to encourage marketers to voluntarily remove their products from the market to avoid more formal action. Continue Reading Important Milestone for CBD Products in England and Wales

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

On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.

The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.

Continue Reading New EU Regulation Reinforcing the Role of the EMA

A lot has been happening in the world of medical devices over the last few months – we set out some key points below.

Progressive roll-out of the IVDR

As discussed in our previous blog, the European Commission published a proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (“IVDR”) by amending the transitional provisions for certain products. This was agreed by the European Parliament and the Council without any amendments to the Commission text. It has now been formally signed, and published in the Official Journal as Regulation (EU) 2022/112.

Continue Reading Update on the MDR and IVDR in the EU