Euro Roundup: UK government moves to modernize legislative framework for medicines and devices
The UK government has filed legal amendments intended to modernize the regulation of medicines and medical devices.
Through the amendments, the government could change the law on sharing information about medical products, make it easier to update legislation, and enable development of the medtech licensing regime. The amendments are part of a broader set of proposed reforms affecting the Medicines and Healthcare products Regulatory Agency (MHRA).
If passed, the information sharing amendment will allow MHRA to provide UK government organizations and global regulatory partners with specific details of medicines and medical devices. The proposed powers will apply when sharing information supports public health, patient safety, access to innovation, and effective regulation.
The regulatory reform measures would support automatic legislative updates in response to changes to documents such as technical standards and international guidelines. MHRA framed the amendment as a way to enable live changes, support smarter, faster regulation, and help the UK’s regulatory system keep pace with advances in science, medicine, and healthcare technology.
Through the third amendment, the government aims to provide the legal foundation for a future medical device framework centered on licenses issued by MHRA, rather than third-party conformity assessments. The framework needs developing through policy work, public consultation, and other steps, but the law now passing through Parliament offers an opportunity to lay the groundwork for the system.
NICE adopts new approach to valuing medicines’ impact on health-related quality of life
The UK National Institute for Health and Care Excellence (NICE) has updated how it values the effects of health products on quality of life.
NICE began using the EQ-5D-3L quality-of-life value set in 2012. Value sets assess what the public says it values about health. Under the 3L set, patients are categorized as having no problems, some problems, or extreme problems. The newly adopted tool, EQ-5D-5L, grades each dimension of quality of life on five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
EQ-5D-5L, which was introduced in 2009, is designed to improve sensitivity and reduce ceiling effects. While a proposed value set for England was published in 2018, NICE continued to recommend the older 3L system amid concerns about the 5L approach.
The development of a new 5L value set triggered a NICE consultation this year. Last week, NICE published an interim methods statement on implementing the 5L value set. In the statement, NICE answers queries about mapping, generating economic model evidence, and other aspects of the value set.
Trade group ABPI warned that the practical consequences of 5L will only become clear as evaluations work through the system. Applying the 5L value set to old NICE evaluations, researchers recently found that the new system benefits products that extend life, such as cancer treatments, but disadvantages drugs that improve quality of life. The impact of the new value set needs monitoring closely, ABPI said.
“Methods updates of this kind are intended to keep NICE’s decisions aligned with what people in the UK value about their health,” ABPI said. “Whether this is the case will be demonstrated by patients’ continued ability to access treatments that matter for them, promptly and equitably, across all types of conditions.”
Swissmedic posts guidance on requirements of responsible person for pharmacovigilance
The Swiss Agency for Therapeutic Products (Swissmedic) has published guidance on the requirements of the responsible person for pharmacovigilance (RPV) for human medicines.
Swiss law requires manufacturers of therapeutic products and distributors of ready-to-use medicinal products to have safety notification systems. Companies must incorporate safety platforms into quality management systems. Functions of notification systems include recording and archiving all safety-related information, continuously assessing pharmacovigilance data, and supporting risk-minimization measures.
Marketing authorization holders and manufacturers designate RPVs, who are responsible for fulfilling the obligation to report adverse drug reactions. Swissmedic created its new guidance to specify the Swiss requirements for RPVs and their deputies.
The RPV and their deputy must be appointed and available when an application for an establishment license with market release is submitted. Once a submission is filed, applicants are required to notify the agency of any safety-related information.
RPVs remain obligated to notify Swissmedic of safety information until the expiry date of the last batch supplied. As Swissmedic explained in the guidance, the obligation means RPVs need to file information even if the establishment license is no longer valid.
The RPV and their deputy can reside outside Switzerland and do not need to be employed directly by the company. Companies must clearly set out responsibilities in writing when delegating pharmacovigilance tasks to external, appropriately qualified third parties.
EMA starts pilot to improve submission readiness and timeline predictability
EMA has launched an 18-month pilot to improve submission readiness and support more predictable assessment timelines.
Through its pre-submission interactions (PSI) model pilot, EMA is introducing shared ownership between the applicant, rapporteurs, and its own staff on submission timing. The agency has struggled to improve the predictability of submission timing, with early actions failing to achieve significant gains and recent initiatives achieving modest improvements.
Under PSI, the agency will interact with applicants in writing five months before they intend to file for approval. EMA has created a PSI form to enable the exchanges and plans to provide feedback within three weeks of receiving materials from the applicant.
Three months before the submission date, EMA will meet with the applicant and rapporteurs. EMA sees the meeting as a chance to discuss dossier maturity and confirm submission readiness. The agency calls the meeting EUSTART, which stands for EU submission, timelines, and review talk. After the meeting, the applicant will file a letter of intent reflecting the agreed submission date.
EMA built written and verbal dialog into the process to reduce the risk that applicants will seek approval based on immature data, which can lead to delays, clock-stop extensions, or the need to file substantial new data during assessment.
The agency has begun accepting applicants for the pilot, which is scheduled to run from February 2027 to September 2028. Participation in the PSI pilot is voluntary.
EDQM updates guidance on applications for ‘sister files’ to support consistent usage
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has clarified a procedure intended to harmonize and accelerate assessments. The revised guidance took effect on 1 September.
EDQM’s updated guidance applies to companies that have received a certificate of suitability (CEP) and want to apply for another CEP for the same substance. Applicants may wish to apply for a second CEP because they do not meet the revision requirements or because they want a separate certificate for an alternative manufacturing process, site, or grade.
The sister file procedure facilitates such submissions. Based on years of experience with the procedure, EDQM has updated its guidance to clarify eligibility criteria, support the correct classification and assessment of CEP applications, and promote transparency and equal treatment of applicants.
EDQM named information on conditions that sister file applications must meet as a key clarification. A sister file application is unlikely to be accepted if the new manufacturing process foresees the formation of different intermediates or the use of different starting materials or reagents. In such scenarios, applicants need to show the underlying chemical principles and reaction mechanisms are the same.
The directorate also revised its guidance on using a CEP to describe a material used in an application for another CEP. The changes reflect the implementation of CEP 2.0 and EMA’s advice on how to use CEPs in marketing authorization applications and variations.
