Latest Regulatory Updates

June 2024

Welcome back to the Boyds Regulatory Intelligence Digest. This month we are sharing the latest guidance and key updates from the regulatory agencies - FDA, EMA, and MHRA.

Food and Drug Administration (FDA)

Artificial Intelligence (AI) and Machine Learning (ML)

FDA released two discussion papers about AI and ML in drug development and manufacturing of drug and biological products. The first paper includes an overview of the current and potential future uses for AI/ML in therapeutic development and discusses the possible concerns and risks associated with these innovations and ways to address them. The second paper discusses AI in drug manufacturing as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.

Regulatory Science Tool (RST) catalogue

FDA’s Office of Science and Engineering Laboratories launched an improved online RST Catalogue, which is now organized by research program and device type, cross referenced by both program and RST category, and an online portal for many OSEL-developed applications including the Device and Material Safety Evaluation Library.

Final rule

FDA issued a final rule on laboratory developed tests by proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of these products is a laboratory. This novel approach is planned to reflect that the device definition in the FD&C Act does not differentiate between entities manufacturing the device and provides further clarity. In addition, FDA also proposes to phase out its general enforcement discretion approach for laboratory developed tests (LDTs). As a result, IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

Final guidance

FDA released the final version of its guidance on Remanufacturing of Medical Devices to distinguish between remanufacturing and servicing and help clarify whether activities performed on devices are likely "remanufacturing," which differs from servicing activities such as maintenance and repair. Additionally, the guidance recommends information to be included in the labelling of reusable medical devices to help ensure their continued quality and safety during servicing. 

Final guidance

In April FDA published guidance for Drug Products, Including Biological Products, that Contain Nanomaterials, which focuses on identifying and managing risks that are present when nanomaterials are present in finished dosage form. A short podcast is also available on the subject. 

Draft guidance out for comment

FDA issued the Platform Technology Designation Program for Drug Development draft guidance, outlining how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation. It describes eligibility factors for designation, potential benefits of designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. Submit comments by 29 July 2024.

European Medicines Agency (EMA) 

Clinical Trials

Revised Recommendations related to contraception and pregnancy testing in clinical trials (Version 1.2) are available on the Clinical Trials Coordination Group (CTCG) website.

Combined Studies

In a recently published Analysis Phase Report, key stakeholders analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory landscape. The report was delivered by the COMBINE project, which aims to address the issues linked to the interface between three EU regulations: the Clinical Trials Regulation (CTR), the Medical Devices Regulation (MDR), and the In vitro Diagnostic Medical Devices Regulation (IVDR).

Medical devices

The revised guidance in the form of a question-and-answer document (Rev 4) provides practical considerations on the implementation of the medical devices and IVD medical devices Regulations ((EU) 2017/745 and (EU) 2017/746). A tracked version highlighting the updates is available here.

Annual report

EMA published its 2023 annual report highlighting progress in science, medicines and health. With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.

Newsletter: SME Highlights – Issue June 2024

The bulletin highlights news, documents, and activities of interest to SMEs and their stakeholders, and this month includes the 2023 SME office annual report. This issue also features the 2024 SME survey for stakeholders to provide feedback on the support, services and incentives provided to SMEs by EMA. Deadline for the survey is the 12 July 2024.

Medicines and Healthcare products Regulatory Agency (MHRA)

International Recognition Procedure

New supplementary information and a recording of a webinar presents post-launch updates and latest information about this new procedure for medicines licensing applications utilising pre-existing approvals from Australia (AUS), Canada (CAN), the European Union (EU), Japan, Switzerland, Singapore and the United States of America (USA).

At the same time the MHRA announced aproposed framework for international recognition of medical devices. Thestatement of policydescribes how the UK Government intends to recognise regulatory approvals from AUS, CAN, the EU and USA depending on device type, class, and prior approval.

Medical Technology Pathway - consultation

NICE and NHS England announce plan to enable innovative technology to be adopted quicker. The consultation document sets out proposals for moving towards a more rules-based, integrated, and predictable pathway for the evaluation, funding, and commissioning of medtech in the NHS. The pathway will apply across the entire lifecycle from promising early-stage technologies; to groups of new, innovative products ready for a National Institute for Health and Care Excellence (NICE) assessment of clinical and cost-effectiveness; as well as existing technologies in widespread use where there is scope to drive greater value.

The consultation closes 15 August 2024.

Change to annual progress reports and safety reports

To help streamline processes for researchers and staff theHealth Research Authority (HRA) is making some changes. From 1 June 2024 study teams will no longer be required to submit annual progress reports, plus there will be changes to how HRA acknowledge SUSARS and annual safety reports (ASR). Non-fatal/life-threatening suspected unexpected serious adverse reactions (SUSAR) or ASR submitted to the HRA will be acknowledged by email by the research ethics committee. The submitted cover report for the SUSAR or ASR will not be signed and returned, the email will act as the formal acknowledgement.

Medical devices

The MHRA has opened a public consultation on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices. See also related press release.

The consultation closes 14 June 2024.

Medical devices

The MHRA has announced aproposed framework for international recognition of medical devices. This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry.

Regulatory sandbox – Artificial Intelligence (AI)

The AI Airlock, a new regulatory sandbox, was launched in May by the MHRA to address the challenges of regulating medical devices using AI and influence future guidance. This pilot is in response of the agency’s strategic approach to AI and seeks to support up to six virtual or real-world projects to help address novel regulatory challenges across sectors for these devices when they are used for direct clinical purposes within the NHS. See here for further information and how to get involved.

Podcast: Conversations in Drug Development

In this episode, our host Harriet Edwards hands over the mic to Nick Meyers, VP of Product Development, and Neil Fish, VP of Business Development at Boyds to discuss a critical topic for early-stage biotech companies: funding challenges and how to overcome them.

Tune in to gain expert advice and ensure your investment approach is well-prepared and effective. If you would like further expertise to help you secure funding and become investment-ready, the team at Boyds provides support to early-stage companies through our B-Investor-Ready service.

Tune in and listen now, search Conversations in Drug Development on your favourite streaming platform or visit Podcast | Conversations in Drug Development | Boyds (boydconsultants.com).