Euro Roundup: MHRA vows to increase oversight of high-risk products

The UK Medicines and Healthcare products Regulatory Agency (MHRA) will increase oversight of high-risk products, particularly new technologies, while simultaneously reducing regulatory oversight of products “where there is clear evidence of a lower risk to patients.” The risk-based framework, plus a focus on addressing health inequalities and promoting sustainability, will inform MHRA’s pursuit of four strategic priorities through 2026.

MHRA’s four strategic priorities, outlined in its corporate plan, are to: maintain public trust through transparency and proactive communication; enable healthcare access to safe and effective medical products; deliver scientific and regulatory excellence through strategic partnerships; and become an agency where people flourish alongside a responsive customer service culture.

For each priority, MHRA discussed the thinking behind the objective and listed actions it will take in each of the next three years. The annual objectives for 2023 seek to stabilize the agency, which is still adapting to Brexit and budget changes and has been taking longer and longer to process clinical trial filings (RELATED: Euro Roundup, Regulatory Focus, 19 April 2023). One of MHRA’s goals for 2023 is to “deliver predictable and reliable operational performance.” Developing “a new financial plan” is another goal for this year.

MHRA also plans to “launch the improved regulatory management system” this year. The goal is to make MHRA services more streamlined, as the first phase of the replacement of legacy IT systems, and enable “all new product licenses, variations, inspections, and process licenses to be efficiently handled, maximizing the use of self-service for low-risk decisions.”

The objectives for the second year include the optimization of service delivery times in priority areas, including scientific advice, to improve MHRA’s “ranking for quality and turnaround times against comparable regulators.” In that year, MHRA also plans “introduce new guidance and legislation, building [its] status as an independent regulator in a global environment” and “improve patient access by formalizing new recognition pathways for UK approval.”

Year three, which covers the 12 months up to 31 March 2026, features some of the most ambitious goals. In that year, MHRA wants to “transform the regulation of generic medicines, building on defined criteria to meet evolving goals where regulator involvement adds most value, for example for sustainable medicines including green chemistry and reduction of plastics.”

MHRA also plans to “implement a revised regulatory framework for compliance” in the third year. The planned framework will be “outcome-based” and support the implementation of MHRA’s plans for “wider regulatory reforms such as the clinical trials framework and new provisions for point of care manufacture.” Year three will also see MHRA “embed lifecycle risk proportionate approaches enabling a greater proportion of self-declared or ’do and tell’ processing, where defined safety and efficacy criteria are met and there is explicit allocation of responsibility.”

The objectives show how MHRA plans to adapt to Brexit. Lacking the support of the European Union regulatory network, the agency plans to rely more on the decisions of a network of its global peers and allow more self-declarations by businesses to free up resources to focus on high-risk areas.

Press Release, Corporate Report

EMA answers questions on allowing overseas regulators to participate in scientific assessments

The European Medicines Agency (EMA) has answered questions on OPEN, a framework that allows overseas regulatory agencies to participate in and contribute to its scientific assessments.

EMA began piloting the framework late in 2020 to support global collaboration on COVID-19 vaccines and drugs. Regulators from Australia, Canada, Japan and Switzerland, as well as the World Health Organization, took part in the pilot.

Having successfully piloted the approach, EMA has extended OPEN to other therapeutic areas. Broader use of the framework is intended to enable the sharing of expertise, harmonize regulatory approaches, accelerate access to new medicines and increase the transparency of regulatory decision-making.

EMA shared more information in a question-and-answer document this week. The document explains that the framework is open to authorities with permanent confidentiality agreements with EMA, a list of agencies that includes the participants in the pilot plus Brazil and Canada.

The expanded program is open to antimicrobial resistance products, medicines designated under EMA’s PRIME scheme (excluding advanced therapies, for now), other treatments that address high unmet needs and therapies that target health threats or public health emergencies.

EMA and at least one OPEN partner must agree to collaborate for a product to be assessed under the framework. The agency can refuse to include a submission in the OPEN framework “on the grounds of overall workload.”

EMA Q&A

Commission shares guidance on parallel EMA-HTA advice during transition to new regulations

The European Commission and EMA have published guidance on the transition to the full application of the new regulation on health technology assessment (HTAR) in January 2025.

Currently, EMA runs scientific consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium to make it easier for sponsors to understand the evidence they will need to receive marketing authorization and reimbursement. However, that EUnetHTA pathway will close in September and HTAR will only become fully applicable in January 2025. In the interim, a consultation approach called Parallel EMA/HTA body Scientific Advice will apply.

Applicants can request the involvement of HTA bodies when applying for scientific advice from EMA. A minimum of two HTA bodies may participate voluntarily. Advice will be limited to the EMA response if fewer than two HTA bodies want to participate.

The guidance describes the selection criteria, which prioritize first-in-class candidates that address unmet medical needs and explains that the result of the selection will depend on the resources at each HTA body. Participants in the program will receive a scientific advice letter from EMA and “individual written recommendations from participating HTA bodies.”

EU Guidance

Swissmedic creates nitrosamine expert group to coordinate with manufacturers, regulators

The Swiss Agency for Therapeutic Products (Swissmedic) has formed a “Nitrosamine Specialist Group” to handle matters related to potentially carcinogenic impurities.

Swissmedic, like its peers, has been investigating the problem and potential responses since nitrosamine impurities were found in antihypertensive medications in 2018. The following year, the agency asked affected marketing authorization holders to take certain steps to limit the concentration of the impurities in their medicinal products.

The specialist group brings together experts from different Swissmedic divisions. The group will “ensure specialist expertise on physico-chemical and toxicological assessments of nitrosamines, coordinate expert exchange with manufacturers and international partner authorities, and represent Swissmedic in specialist international bodies,” according to the agency.

The group will serve as the coordination office and single point of contact for nitrosamine questions. Swissmedic set the group up on July 1 in response to a decision by its management board.

Swissmedic Notice

Other news:

The Medical Device Coordination Group (MDCG) has revised its position on a power related to expired device certificates. The group now recommends the Medical Device Regulation power is only used in “very exceptional situations.” MDCG Document

Euro Roundup: MHRA vows to increase oversight of high-risk products

Related topics

Recommended content

Welcome to the new RAPS Digital Experience