Euro Roundup: EMA releases strategy for implementing ICH guideline on post-approval safety data

The European Medicines Agency (EMA) has published a strategy for implementing international guidelines on managing post-approval safety data.

EMA’s strategy applies to the first revision of the International Council for Harmonisation’s (ICH) E2D guideline, which officially takes effect in the European Union on 18 March. The revised guideline includes updated definitions and standards intended to support appropriate safety surveillance, plus new advice on managing safety data from non-interventional studies.

Ahead of ICH E2D(R1) coming into force, EMA has shared guidance for marketing authorization holders, national competent authorities, and inspectors to smooth the transition to the new requirements. The implementation strategy covers the new definition of “patient support program” and the newly required detailed documentation for organized data collection systems not conducted according to a protocol.

ICH’s patient support program definition excludes activities that only allow one-way interactions, such as the delivery of a product to a patient’s home or the provision of vouchers or coupons. The exclusion led EMA to advise marketing authorization holders to manage adverse event reports from such interactions as spontaneous, not solicited.

In the EU, organized data collection systems fall under the definition of solicited reports. ICH E2D(R1) introduces a new provision requiring companies to have documentation in place when the activities are not carried out according to a protocol. EMA expects companies to have ICH E2D(R1) documentation in place by 18 September.

The documentation for new and ongoing activities should include the objectives of the organized data collection system, the sources of the data, and the process for collecting and managing adverse event reports. EMA has imposed additional requirements on new activities, such as the need for companies to include details of their methods for reviewing the dataset to meet the activity’s objective.

EMA expects companies to maintain the documentation with oversight by the QP responsible for pharmacovigilance. Companies must provide documentation to EMA and national agencies on request.

EMA Strategy

MHRA shares guidance on GMPs and using radiopharmaceuticals in clinical trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance on good manufacturing practices (GMPs) and using investigational radiopharmaceuticals in clinical trials.

MHRA defines radiopharmaceuticals as products that, when ready for use, contain one or more radionuclides for a medicinal purpose. The Clinical Trials Regulations (CTR), which were updated last year, exempts diagnostic radiopharmaceuticals from the typical requirement for authorization to manufacture investigational medicinal products.

The provision allows the production of diagnostic radiopharmaceuticals at sites that hold a license to make specials or an MHRA manufacturing license that includes investigational radiopharmaceutical products. Sites with traditional licenses to manufacture investigational medicines can also make the products.

As MHRA explains in the draft, the radiopharmaceutical product “may be manufactured within a licensed facility, such that they can supply a hospital or health centre which is a trial location or taking part in the trial.” MHRA said the exemption does not remove the need to comply with release requirements, including the necessity to involve a qualified person (QP) in the process.

Sponsors must ensure clinical trial approval applications include details of the licensed facility that is undertaking final batch release and QP certification, as well as the licensed facility that is handling the radiolabeling. MHRA expects sponsors to have technical agreements with facilities to confirm quality oversight and responsibilities.

Another section of the guidance covers the radiolabeling of diagnostic “cold kit” investigational products. Cold kits are non-radioactive preparations that require radiolabeling. Under CTR, sites with licenses for manufacturing specials can radiolabel cold kits via the addition of the appropriate radioisotope. Sponsors should ensure sites with specials licenses have suitable quality systems and physical labeling controls.

Therapeutic radiopharmaceuticals are outside the scope of the CTR exemption. MHRA said such products must continue to be made at facilities with a UK manufacturing and import authorization license.

MHRA is seeking feedback on the draft guidance until 25 March. The agency wants to know if stakeholders found the guidance easy to read and follow, felt the technical terms and concepts were clearly explained, and understood how to apply the document to real-world scenarios. MHRA has also provided a free-text field for any other comments.

MHRA Guidance

MHRA developing regulatory environment for space-enabled manufacturing processes

MHRA is working with other UK bodies to create a supportive regulatory environment for space-enabled manufacturing processes.

The microgravity environment found in space could enable more precise drug formulation, potentially driving improved solubility, purity, crystallization, and stability for biologics and protein-based drugs. With companies keen to explore in-orbit manufacturing, MHRA is working with the UK Space Agency, the Regulatory Innovation Office, and the Civil Aviation Authority on the regulatory environment.

MHRA’s role includes producing collaborative case studies with the UK Space Agency to clarify regulatory expectations and making its experts available to explain requirements, expectations, and best practices within existing frameworks. The agency has supported an ongoing in-orbit demonstrator feasibility study that could help clarify whether terrestrial manufacturing regulations will apply to drugs made in space.

Joint Statement, Press Release

MedTech Europe calls for fast adoption of notified body act to send signal of stability

MedTech Europe is pushing for authorities to adopt changes to the rules on notified bodies soon to send a clear signal of stability and responsiveness.

The trade group said the European Commission is developing a new implementing regulation covering the assessment activities done by notified bodies to certify medtech quality systems and products. After reviewing the draft, MedTech Europe said the Commission’s plans to establish predictable timelines and transparent costs are practical and workable.

MedTech Europe said clearer timelines, structured stop-the-clock mechanisms, and more transparency on process indicators and fees could significantly strengthen the predictability and efficiency of the EU’s regulatory system. Making the process more predictable could support timely patient access to devices and help sustain the EU’s industrial base, the trade group said.

Press Release

Other News:

MedTech Europe and more than 60 other industry associations have called on the European Commission to stand firm in the drafting of the New Circular Economy Act (CEA). The groups want officials to push back against attempts to weaken CEA’s ambition “disguised as flexibility, under the pretext of defending national specificities,” and create common waste management rules across the region. Joint Statement

Medicines for Europe has urged EU leaders involved in Critical Medicines Act (CMA) negotiations to keep demand-side policies in the legislation. The trade group, which represents off-patent drugmakers, said CMA will fail to achieve its aims of improving the availability, supply, and production of critical medicines within the EU without the policies. Final CMA negotiations are underway. Open Letter

The European Commission has published expert panel decisions about devices for treating osteoarthritis and Peyronie’s disease. The experts ruled the notified bodies should order a randomized clinical trial of the osteoarthritis device and request additional information about potential pharmacological effects of the Peyronie’s treatment. Osteoarthritis Opinion, Peyronie’s Opinion

The Swiss Agency for Therapeutic Products (Swissmedic) has published the fourth version of its position paper on decentralized clinical trials. Working with swissethics, the agency has revised the appendices to reflect the European Commission’s updated recommendation paper on decentralized elements in clinical trials. The appendices compare the rules in Switzerland and EU member states. Swissmedic Notice

Euro Roundup: EMA releases strategy for implementing ICH guideline on post-approval safety data

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