Euro Roundup: EMA updates guidelines on good pharmacovigilance practices

The European Medicines Agency (EMA) has updated its guidelines on good pharmacovigilance practice (GVP) with new information on risk-minimization measures and updated definitions.

EMA made changes to four documents in its suite of GVP guidelines, including revisions to the cover note that provides an overview of the agency’s approach to adverse events. The agency has updated a module and addendum on risk-minimization measures to reflect public feedback, recent experiences, research on the topic and “overall advances in the field drawing from the implementation science.”

The draft module released for consultation in 2021 featured changes intended to clarify the role of risk minimization for risk-management planning, give more guidance on the criteria for applying additional measures and update the concept of controlled access systems. EMA made more changes in response to feedback on the draft.

EMA’s final version, which came into effect on 6 August, clarifies that digital applications may be considered to support risk-minimization as technology advances. Digital applications may be considered without any further guidance in the module while an EMA reflection paper on digital support to risk minimization is under development.

The agency also used the finalization process to elaborate “on the iterative and non-promotional nature” of risk-minimization measures. EMA has included a graphic showing the benefit-risk management cycle of medicinal products. The graphic shows how the use of a product and implementation of measures to minimize risk in healthcare provides information to support the evaluation of the measures, which, in turn, informs quantitative and qualitative benefit-risk evidence generation.

EMA also finalized an addendum to the risk-minimization module. The addendum covers methods for evaluating the effectiveness of risk minimization measures. In finalizing the addendum, EMA has placed more emphasis on the importance of a mixed methods approach to evaluating outcomes, clarified the role of spontaneous reporting systems and added references to human factors as enablers and barriers to the implementation of measures.

The update to the risk-minimization modules introduced new terminology. In response, EMA revised a GVP annex on definitions. The agency added definitions of healthcare professional, patient and target population in accordance with the revised risk-minimization documents.

EMA made changes to its definition of risk-minimization measure. The agency retained some of the text but added new information, including the statement that “conceptually” the measures consist of two components. The key information about the risk and actions intended to be taken by the healthcare professional to minimize it is one component. The tool used to share the message is the other part. Tools are either routine, such as package leaflets, or additional, such as risk-minimization control tools.

The agency also deleted its previous definition of adverse event. With the Clinical Trials Regulation now in effect, EMA has switched to new text that gives slightly different definitions for adverse events in trials and in the real world. Other changes include the addition of definitions of disease registry, immunization stress-related response and primary data collection.

Cover Note

First module of swissdamed database goes live

The first module of the new Swiss database for registering economic operators and medical devices went online on 6 August.

Through the swissdamed database, the Swiss Agency for Therapeutic Products (Swissmedic) said it is “aiming to provide an overview of the medical devices, including in vitro diagnostic medical devices, available on the Swiss market and the economic operators responsible for them.” The database, which will expand to publish details of devices and their manufacturers, is intended to improve transparency.

The first of two modules, called “actors,” is now live. Economic operators can use the module to register online. Swissmedic has contacted economic operators who had already registered before swissdamed became available to communicate the next steps.

“In order to preserve equivalence between the Swiss and EU regulations and minimise the effort for economic operators, swissdamed resembles the corresponding modules of the European database Eudamed,” Swissmedic said.

The second module, called “devices,” is scheduled to go live in several phases. The first release, which is planned for 2025, will enable companies to register “regulation devices” by uploading XML files using the Eudamed format. Later releases will complete the module. Swissmedic will make device registration mandatory once the database “has been sufficiently developed” and legislation has been amended.

Swissmedic Notice

EMA shares ICH reflection paper on real-world evidence

EMA has published an International Council for Harmonisation (ICH) reflection paper on opportunities for real-world evidence (RWE) harmonization.

ICH created the paper to advance the harmonization of RWE terminology and enable the convergence of general principles for planning and reporting real-world data studies to support regulatory decisions. The paper, which was recently finalized following a public consultation, identifies opportunities to harmonize the format for protocols and study result reports sent to regulators throughout the product lifecycle.

“By supporting the delivery of a regulatory system able to integrate RWE in a more harmonized way into submissions for medicines approval and decision-making, this proposal can support timely decisions on the development of innovative treatments, help to address unmet medical needs and support the safe and effective use of medicines,” ICH said.

EMA’s Committee for Medicinal Products for Human Use has adopted the reflection paper. The agency co-sponsored the reflection paper with the US Food and Drug Administration and Health Canada.

Reflection Paper

Swissmedic rules suicide capsule does not meet therapeutic product definition

Swissmedic’s initial assessment of public information on the Sarco suicide capsule has concluded the device does not meet the definition of a therapeutic product.

The 3D-printed, human-sized capsule is intended for use in assisted suicide but has caused controversy in Switzerland. After climbing into the capsule and closing the lid, an individual can press a button to release nitrogen into the chamber. The release of nitrogen causes the person to lose consciousness and soon die from a lack of oxygen.

Amid the controversy, private individuals, the media and authorities have contacted Swissmedic about the device. The interest led Swissmedic to qualify the device according to Swiss regulations and legislation.

Swissmedic concluded the purpose of the device “fundamentally contradicts the medical purpose of a therapeutic product.” The nitrogen gas is not a medicinal product because it “serves only to change the composition of the air in the closed capsule,” Swissmedic said, and a device used for suicide contradicts the medical purpose under therapeutic legislation and cannot be classified as a medical device.

The conclusion leaves the question of what legislation applies to Sarco unresolved. Swissmedic said “regulatory clarifications on the qualification and legitimation of the device from a legal, health policy and ethical perspective would appear to be advisable, along with a broad-based public discussion.”

Swissmedic Notice

Other News:

The European Commission has posted an implementing regulation to renew the designation of entities that issue unique device identifiers (UDIs). Under the original implementing decision, the designations granted to four issuing entities last five years. With the period ending, the Commission has renewed the designations to extend their validity into 2029. Implementing Regulation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance with details of the support its clinical investigations team offers device developers. Companies can request a meeting and receive guidance on navigating the regulatory landscape. MHRA cannot review individual documents. MHRA Guidance

Euro Roundup: EMA updates guidelines on good pharmacovigilance practices

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