Euro Roundup: EMA shares draft guideline on smaller-sized allergy trials

The European Medicines Agency (EMA) is seeking feedback on a draft guideline that sets out its views on the development of immunotherapies and diagnostics for allergies with moderate- to low-sized study populations.

Several guidelines already provide advice on the quality and clinical development of allergen products but those documents assume “a sufficient number of patients” are available for studies, according to EMA. Such populations are not found in allergies “where a severely limited number of patients are available to study and/or where clinical co-allergies are common.”

Few products are authorized for such allergies; therefore, EMA is developing a guideline that describes the quality, non-clinical, safety and efficacy data that companies need to provide “sufficient scientific evidence” for approval when adequate data cannot reasonably be obtained.

“The data set which will be achievable from moderate- to low-sized populations may be limited,” EMA wrote. “Accordingly, it is assumed that mainly the claim ’treatment of allergic symptoms’ will be targeted. Other claims may be possible if substantiated by data.”

For immunotherapy studies, EMA agency sees “environmental exposure chambers with inhalant allergens” as a way to enhance patient selection, although it acknowledges that the approach may be challenging to adopt in multinational Phase 3 studies.

The agency described co-sensitization as “a major issue ... for field studies of common allergens,” adding that it is even harder to find “monosensitized patients” in moderate to low-sized populations. EMA sees provocation tests as potentially “very helpful for inclusion of patients.”

EMA is accepting feedback until 31 May.

Draft Guideline

MHRA changes process to shorten reviews of established medicines

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a new process for assessing established chemical medicines to shorten review times.

MHRA, which switched to the new process on 1 March, will use the updated workflow when assessing chemical products that are “not new active substances or line extensions to new active substances.” The agency will review biosimilars using a different process.

When MHRA begins assessing a submission that is eligible for the new process, it will perform a technical completeness check of the application. The agency will refuse submission if the applicant has failed to provide the data required under the Human Medicines Regulations 2012.

“Examples of this include incomplete documentation even where there are commitments given to provide pivotal data during the assessment procedure,” MHRA wrote.

The agency will only scientifically assess applications that are technically complete and will only send one Request for Further Information. MHRA will ask successful applicants to send a template pre-populated with the Lay Summary for the UK Public Assessment Report.

MHRA made the changes “to eliminate the most frequently seen deficiencies” and ensure a “smoother and more rapid approvals process for applicants.” The agency framed the update as a continuation of the reliance procedure measures it introduced at the start of the year.

Press Release, Guidance

EMA, Swissmedic start consultations into draft ICH guideline on post-approval safety data

EMA and its Swiss counterpart are seeking feedback on a draft International Council for Harmonisation (ICH) guideline about postapproval safety data.

ICH published the current version of its E2D(R1) guideline in 2003. As the Swiss Agency for Therapeutic Products (Swissmedic) noted in its call for feedback, “new sources of post-approval safety information have emerged or are applied more frequently” since the current version was finalized.

Swissmedic cited social media and market research programs as examples of increasingly important sources of data. There are differences in characteristics of the data sources and “their contribution to the quality of post-approval safety information,” Swissmedic said. The differences led regulators to conclude the ICH E2D definitions and regulatory guidance are no longer sufficient to provide current guidance.

“The original considerations and standards need to be carefully revisited in order to adapt the existing concepts, principles and definitions of the ICH E2D guideline and to support appropriate safety surveillance and actions in consideration of the new sources of safety information,” Swissmedic wrote.

That thinking has informed a major rewrite of the guideline. ICH is proposing to add definitions of terms that have emerged or risen in importance since the 2003 guideline, such as digital platform and patient support program. The draft also features an updated list of sources of individual case safety reports that includes digital platforms.

The current guideline has a section on the Internet but it reflects the online world as of 2003. The draft retains the distinction between platforms that are and are not under the responsibility of the marketing authorization holder that is central to the current advice on the Internet. ICH has updated and expanded the advice to discuss the screening of digital platforms and timeline for reporting adverse events.

EMA and Swissmedic are accepting feedback until 22 June.

Draft Guideline, Swissmedic Notice

EMA expands DARWIN EU data network, outlines plan to add another 10 partners

EMA has expanded its Data Analysis and Real World Interrogation Network DARWIN EU and outlined plans to add another 10 partners this year.

The DARWIN EU network of data partners generates real-world evidence from sources such as hospitals, primary care, health insurance, registries and biobanks. EMA is using the data to support the activities of its scientific committees and to assist national regulators in the European Union. The network began with 10 data partners.

EMA delivered on its goal of adding 10 data partners a year in 2023. The partners now have access to data from around 130 million people. Having grown to include 20 public or private institutions from 13 European countries, EMA wants to add another 10 partners to the network this year.

The network has supported 14 completed real-world data studies, plus 11 ongoing projects, to date. The studies cover “drug utilization, vaccine effectiveness, disease epidemiology and patient characterization,” EMA said.

EMA highlighted two recently completed studies as examples of the power of the network. One study of the use of medicines in systemic lupus erythematosus gave an EMA committee information on the pediatric population potentially available for clinical trials and the similarities between adults and children. Other studies are piloting the use of the data in health technology assessments.

Press Release

Other news:

EMA’s Quality Innovation Group has released draft considerations on pharmaceutical process models. The document is a response to “an acceleration in the advancements for process control and automation including sensor technology, data analytics and system modeling.” Regulatory expectations for process models in manufacturing are changing, leading EMA to share its thinking and seek feedback. EMA Report

Ireland’s Health Products Regulatory Authority (HPRA) has shared the findings of investigations into the use of botulinum toxin medicines. HPRA has seen a “growing trend where certain individuals offering aesthetic services may be operating outside the law” and aiming to take advantage of the public. HPRA Notice, More

MHRA has approved diagnostic tools for adults with prostate cancer and the assessment of suspected or known coronary heart disease. MHRA Notice, More

Euro Roundup: EMA shares draft guideline on smaller-sized allergy trials

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