Euro Roundup: UK regulators to create a ‘sandbox’ for AI development; EMA eliminates delay in publishing clinical trials data

The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to create a new “regulatory sandbox” for artificial intelligence (AI) developers to test their technologies and generate evidence in a regulator-monitored virtual space. The tool, called AI-Airlock, is expected to launch in April 2024.

AI-Airlock is a partnership between government, regulators and industry and will allow for the use of advanced AI technology in National Health Service (NHS) settings ahead of regulatory approval but under safety controls, according to the announcement. “Where successful, the AI-Airlock will help NHS patients to benefit earlier from emerging technologies before they are available anywhere else in the world,” MHRA said.

“The deployment of AI and machine learning-enabled med-tech devices is challenging, given the level of complexity of these products,” Paul Campbell, MHRA Head of Software and AI, said in a statement. “However, by moving beyond conventional product concepts and associated regulations, sandboxes like the AI-Airlock offer a unique and safe learning space for manufacturers to work with regulators and other parties to explore new, cutting-edge solutions to help resolve these challenges.”
Funding for AI-Airlock will come from the UK Department of Science, Innovation and Technology and the Department of Health and Social Care.

AI-Airlock Announcement
EMA revises transparency rules for CTIS

The European Medicines Agency (EMA) issued revised transparency rules for publishing clinical trials information through the EU Clinical Trials Information System (CTIS), including the removal of the deferral mechanism that had allowed sponsors to delay publishing certain data.

The revisions were prompted by feedback from stakeholders after the 2022 launch of CTIS. The revised rules were adopted in October 2023 and are expected to become effective sometime in the second quarter of 2024, after the technical implementation within CTIS and its public portal.

The revised rules remove the deferral mechanism for every trial category. Previously, the deferral mechanism had allowed sponsors to delay the publication of certain personal data and commercially confidential information for up to seven years after the end of the trial.
Under the new rules, EMA has reduced the published information to focus on what is “more impactful for patients and clinical researchers,” such as study design and protocols, endpoints, and details on the investigational medicinal product used, among other details.

Sponsors should redact documents to protect commercially confidential information and personal data, according to the revised rule. CTIS offers the option to use a document version “for publication” that has been redacted and a document version “not for publication” that may contain sensitive information needed for scientific and regulatory review.

“The simplifications introduced by the revised CTIS transparency rules aim to guarantee access to clinical trial information in a faster and more efficient way,” EMA wrote in the revised document.

Revised Transparency Rules; Announcement

EMA safety committee finds no link between GLP-1 agents and thyroid cancer

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found that current evidence does not support a causal association between glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer.

The committee met 23-26 October 2023 to review a recent study that raised concerns about a link between thyroid cancer and this class of medicines among patients with type 2 diabetes mellitus. The study, published in Diabetes Care in February 2023, found that use of GLP-1 receptor agonists for 1-3 years was linked with an increased risk of thyroid cancer (adjusted hazard ratio: 1.58) and medullary thyroid cancer (adjusted hazard ratio: 1.78).

The PRAC reviewed the study, as well as other published literature and cumulative data submitted by marketing authorization holders, such as non-clinical, clinical and post-marketing data. Based on that evidence, the PRAC determined that no updates to the product information were warranted. However, the marketers of products containing exenatide, liraglutide, dulaglutide, semaglutide and lixisenatide should continue to monitor for safety signals related to thyroid cancer, according to the PRAC announcement.

PRAC Announcement

MHRA issues new guidelines for isotretinoin prescribing

MHRA has introduced new safeguards for prescribing the acne medication isotretinoin, including assessment by two healthcare professionals when prescribing to patients 12-18 years old.

Other new safety measures include providing detailed information about the potential risks of isotretinoin, alongside its benefits. The drug’s product information will be updated to include a statement that healthcare professionals must advise patients and families of the risk of psychiatric and sexual side effects, and the potential side effects will be listed. Additionally, all patients should have in-person assessments of their mental and sexual health before starting treatment and be monitored for side effects during treatment.

The changes were recommended by the Commission on Human Medicine’s Isotretinoin Implementation Expert Advisory Working Group, which includes experts from dermatology, general practice and psychiatry.

“For isotretinoin, there may be possible impacts on mental health and sexual function. While not every patient will experience them, the new measures will ensure that patients are well informed, that they are carefully monitored throughout treatment, and that there is additional oversight on isotretinoin prescribing for patients under 18,” Alison Cave, MHRA Chief Safety Officer, said in a statement.

MHRA Announcement

Norway monitoring antibiotic shortages

The Norwegian Medicines Agency (NoMA) is closely monitoring the availability of antibiotics in the country due to the current shortage of the narrow-spectrum antibiotic, phenoxymethylpenicillin (Apocillin).

Phenoxymethylpenicillin is used to treat respiratory infections and supply issues for both the 660 mg and 1 g strengths of the drug are expected to continue until spring 2024. The shortage is concerning, according to the NoMA, because of the country’s reliance on narrow-spectrum antibiotics to treat bacterial infections while also slowing the development of antibiotic resistance.

“Even though a shortage does not necessarily mean that a drug is completely unavailable, this is a situation we are monitoring closely. Antibiotics are important medications, which is why we have Apocillin in our emergency stockpile. In addition, pharmacies can provide foreign packages of the same medication or switch to an equivalent drug from another manufacturer. We hope that not many people will need to return to the doctor for a new prescription,” Ingrid Aas, NoMA Senior Medical Consultant, said in a statement.

NoMA Statement

EMA recommends approval of Nuvaxovid XBB.1.5

The EMA’s Human Medicines Committee (CHMP) has recommended authorizing an updated version of the Nuvaxovid COVID-19 vaccine that targets the Omicron XBB.1.5 subvariant.

Nuvaxovid XBB.1.5 is indicated for adults and children aged 12 years and older. The vaccine is intended to be given as a single dose regardless of previous COVID-19 vaccines received. The CHMP determined that Nuvaxovid XBB.1.5 should trigger an adequate immune response against the new Omicron subvariant based on laboratory data from the adapted vaccine and data from a study of previously vaccinated adults.

The safety of the adapted Nuvaxovid vaccine is expected to be similar to the originally authorized shot. The most common side effects with Nuvaxovid XBB.1.5 include pain and tenderness at the injection site, fatigue, headache and muscle pain.

The CHMP recommendation is pending before the European Commission, which will issue an EU-wide decision on the vaccine’s authorization.

EMA Announcement

Euro Roundup: UK regulators to create a ‘sandbox’ for AI development; EMA eliminates delay in publishing clinical trials data

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