Euro Roundup: MHRA seeks feedback on codifying early access scheme in legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the proposed inclusion of Early Access to Medicines Scheme (EAMS) principles in legislation.

MHRA introduced EAMS in 2014 to accelerate access to treatments for life-threatening or seriously debilitating conditions. The pathway enables patients to access medicines before they are approved by MHRA. While there have been more than 50 applications for scientific opinions on medicines, the final step in the EAMS process, the pathway is yet to be enshrined in UK legislation.

The shortcomings of the current non-statutory status of EAMS have led MHRA to propose adding the pathway to the Human Medicines Regulations 2012. MHRA identified two overarching goals of the proposed legislative change. First, MHRA wants to improve regulatory certainty by providing a legal basis for the delivery of EAMS. The legislation will describe EAMS, its goals and key principles.

In doing so, MHRA wants to simplify the supply of EAMS medicines. Currently, the manufacturing licenses needed to produce EAMS medicines differ depending on whether they are fully approved in another indication. Obtaining an alternative manufacturing license for an EAMS medicine requires “significant investment in time, cost and administration,” MHRA said, which may be hard to justify supplying a product “for a matter of months” before it receives a full approval.

MHRA wants to avoid “the need to classify supply aspects under existing legislation for unlicensed medicines or off-label provision” by including a “simple administrative procedure” that supports the production and importation of EAMS medicines under any relevant manufacturing license.

The second overarching goal of the planned legislation is to provide a framework for the collection of real-world data. In 2016, a government-sponsored independent review recommended the creation of “a robust mechanism to support real-world data generation during the EAMS patient access period and beyond.” MHRA wants to use the legislative update to establish such a mechanism.

“The new provision would allow for real-world data collection without the need for a CTA, as long as the MHRA (following assessment) has no concerns about the collection of that data. Patients must be appropriately consented and have the right to refuse without impacting their ability to join the scheme,” the agency wrote.

MHRA wants to know if people and organizations affected by the proposals agree with its plans. The consultation, which is open until 17 September, is gathering feedback on concerns about the plans and ideas for additional provisions.

MHRA Survey, Consultation Document

Access Consortium creates work-sharing initiative for biosimilar applications

The Access Consortium that features the Swiss and UK medicine regulatory agencies has created a work-sharing initiative for biosimilar applications, enabling companies to seek approval in multiple markets through a single submission.

Regulatory agencies in Australia, Canada, Singapore and Switzerland have worked together to review submissions for generic medicines for several years as a way to make better use of resources. The work led to the creation of a similar initiative for new active substances. Now, following the addition of MHRA to the consortium, the initiative has expanded to cover biosimilars.

Access outlined the scheme in a short guidance document. The consortium is advising developers of biosimilars to talk to regulators early to determine if work-sharing is feasible for their programs. If possible, Access wants sponsors to submit an expression of interest form up to six months in advance of a submission. Sponsors need to submit the form at least three months before filing.

The scheme is open to sponsors that want to seek approval in at least two Access markets. Sponsors need to file separate applications to the regulator of each targeted market over a two-week window. Access wants the content of the submissions to be consistent, aside from nation-specific application requirements.

Access has made some commitments to applicants. The consortium aims to tell sponsors about the potential for work sharing within six weeks. Regulators handling a submission will allocate roles and tell the sponsor about the work-sharing approach and key milestones “at the earliest opportunity.” While regulators will collaborate on the review, national procedures take over at the labeling and authorization stages.

Swissmedic Notice, More

MHRA and HPRA issue recall notices for batches of Sanofi irbesartan medicines

MHRA and its Irish counterpart have issued recall notices for irbesartan medicines from Sanofi and other manufacturers and distributors. The recalls of the sartan treatments for high blood pressure follow the discovery of an azido impurity that could potentially increase the risk of cancer.

Concerns about the presence of azido impurities in sartan active substances have mounted in recent months, with the European Directorate for the Quality of Medicines issuing a notice in April, Health Canada publicizing recalls in May and several drugmakers pulling products from the UK market in June.

Now, Sanofi is recalling 17 batches of products containing irbesartan from the UK. MHRA shared news of the Sanofi recall of Aprovel and Co-Aprovel alongside details of eight batches from Zentiva and parallel distributors that are also being recalled.

The MHRA statement came days after Ireland’s Health Products Regulatory Authority (HPRA) published details of a recall of sartan medicines. The Irish recall affects certain batches of products containing irbesartan and valsartan from Sanofi and Clonmel Healthcare, as well as one batch at a parallel distributor.

MHRA Notice, HPRA Notice, More

PRAC recommends naming immune thrombocytopenia as adverse reaction to J&J vaccine

The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the addition of immune thrombocytopenia to the list of adverse reactions associated with Johnson & Johnson’s COVID-19 vaccine.

PRAC, part of the European Medicines Agency, wants healthcare professionals and recipients of the vaccine to be warned of the possible side effect and for details of the reaction to be added to the product information. In patients with immune thrombocytopenia, the immune system mistakenly destroys platelets.

Other recommended changes include the reclassification of thrombocytopenia as an important identified risk in the risk management plan and the addition of dizziness and tinnitus as adverse reactions to the product information. PRAC analyzed more than 1,000 cases of dizziness and more than 100 cases of tinnitus before making its recommendation.

PRAC Update

Swissmedic approves Moderna COVID-19 vaccine for use in adolescents

The Swiss Agency for Therapeutic Products (Swissmedic) has extended the temporary authorization for Moderna’s COVID-19 vaccine to cover people aged 12 to 17 years.

Swissmedic approved the indication extension based on data from an ongoing study in 3,732 children aged 12 to 17 years. The study persuaded Swissmedic that the side effects and immune responses in children are similar to those seen in young adults, leading it to clear the Spikevax vaccine for use in adolescents as a two-dose regimen given over four weeks.

The temporary authorization comes weeks after EMA approved Spikevax for use in children. While it is now possible to vaccinate adolescents across the European Union, the positions of member states have diverged, with some countries keeping 16 or 18 years as the minimum age, or only vaccinating minors who have underlying health conditions.

Swissmedic Notice

Other News:

The Spanish Agency of Medicines and Medical Products (AEMPS) has authorized the first clinical trial of a locally developed COVID-19 vaccine. AEMPS Notice (Spanish)

Euro Roundup: MHRA seeks feedback on codifying early access scheme in legislation

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