Euro Roundup: EMA sets July implementation date for ICH GCP guideline

The European Medicines Agency (EMA) will bring updated International Council for Harmonisation (ICH) guidelines on good clinical practices (GCP) into effect on 23 July.

ICH E6 (R3) is the latest version of a GCP guideline that dates back to 1996. Regulatory members of the ICH assembly signed off on the updated document in the first week of 2025, ending a process that began with the endorsement of the topic in 2019. (RELATED: ICH adopts E6(R3) guideline on good clinical practices, Regulatory Focus 14 January 2025)

The new guidance puts more emphasis on proportionality than its predecessor. Version two of the text said steps taken to control quality and reduce risks should be proportionate to the threats a study faces. Version three expands on that idea by encouraging sponsors to design trials that are fit for purpose and sufficient to provide confidence in the trial’s results.

“Clinical trial processes and risk mitigation strategies implemented to support the conduct of the trial should be proportionate to the importance of the data being collected and the risks to trial participant safety and the reliability of trial results,” ICH said.

ICH has also introduced the concept of quality by design, a term that is absent from version two, and tied it to the push for proportionality. Version three recommends sponsors implement quality by design “to identify the factors (i.e., data and processes) that are critical to ensuring trial quality and the risks that threaten the integrity of those factors and ultimately the reliability of the trial results.”

Sponsors should prospectively identify the key factors, ICH said, and use them to inform a proportionate and risk-based approach to quality management. The approach is part of a push to build quality into the scientific and operational design and conduct of clinical trials.

The focus on proportionality and introduction of quality by design were part of the draft ICH released for consultation in 2023. Most of the draft text is unchanged in the final version. Revisions between the two versions include the addition of lines about considering the characteristics of the study population when choosing how to handle informed consent and deciding the level of investigator oversight of the drug.

ICH Guideline

EFPIA calls for harmonized EU drug shortage prevention and mitigation system

EFPIA has called for the European Union to develop a harmonized shortage prevention and mitigation system as part of a package of proposals intended to improve the supply of drugs in the region.

The pharma trade group sees benefits to endorsing a harmonized definition of “shortage” and reporting via an interoperable IT system including the European Shortage Medicine Platform and the European Medicines Verification System. EFPIA wants the harmonized system to maintain the notification period for temporary disruptions to two months.

In parallel, EFPIA wants authorities to “adopt a risk-based approach focused on a harmonized EU list of critical medicines defined through a standardized methodology that evaluates therapeutic indication and availability of alternatives in a market.” The risk-based model would limit the use of shortage prevention and mitigation plans to critical medicines to “optimize resources.”

Other regulatory-focused recommendations include allowing the use of electronic product information and other flexibilities to facilitate “reallocation of medicine stocks such as standardized EU/multi-country packs and labelling.” EFPIA also wants authorities to “enable timely and agile changes to manufacturing processes and the supply chain.” The goal is to stop regulations from creating or worsening shortages.

EFPIA Notice

ABPI seeks urgent answers as drug payment rate jumps to ‘highest-ever level’

Pharma trade group ABPI is “working urgently and collaboratively” with the UK government to understand why the drug pricing payment rate jumped last year.

When the industry agreed to the Voluntary Scheme for Branded Medicines Pricing and Access in 2023, ABPI expected payment rates on sales of branded medicines to the NHS to start at around 15.3% but fall over time. The industry was looking for the rate to “trend back toward a more internationally competitive and sustainable level” across the five-year agreement, ABPI said.

However, the payment rate for newer medicines has increased to 22.9%. ABPI said the new rate is the highest-ever level. The trade group outlined what the unexpected increase in the rate will mean for its members.

“This puts a very real strain on companies, which will not have factored this rate into their business plans for 2025. It means the industry will need to pay around £3.4 billion ($4.2 billion) to the government this year, more than the total payments made over the five-year scheme 2014-2018,” ABPI said.

The trade group is talking to the government to understand why the rate increased and determine how to “return the UK to a more internationally competitive position.”

Press Release

MDCG answers new questions about European Medical Device Nomenclature

The Medical Device Coordination Group (MDCG) has updated its guidance on the European Medical Device Nomenclature (EMDN).

MDCG first published the question-and-answer document in 2021 to explain the role EMDN plays in supporting the Eudamed database and the medtech regulations. The first revision of the document adds answers to almost 20 questions.

Across the updated guidance, MDCH shares information about assigning EMDN codes to unique device identifiers, including what to do if there is no appropriate code, and the annual review procedure. MDCG said it is not currently possible to notify users that are affected by annual code changes, and it does not foresee “contacting individual actors of existing codes” in a consultation process.

MDCG published the updated Q&A alongside details of the decisions its nomenclature working group reached in 2024. The working group document explains why it accepted, partially accepted or rejected requests for code changes.

MDCG Guidance, More

EMA shares work plan for Accelerating Clinical Trials initiative in 2025 and 2026

EMA, the European Commission and the Heads of Medicines Agencies have shared the 2025 to 2026 work plan for the Accelerating Clinical Trials in the European Union (ACT EU) initiative.

ACT EU is intended to make trials better and faster, including through regulatory changes. The work plan shows efforts to realize that objective over the next two years will include a series of workshops related to the implementation of the Clinical Trials Regulation, the publication of the findings of consolidated advice pilots and the release of a simplified package for filing to run trials in public health emergencies.

The activities build on the progress made in 2024. Last year, ACT EU evaluated the first two iterations of the pre-clinical trial application consolidated advice and published guidance for sponsors interested in participating in the pilots.

Work Plan

Other News:

The European Shortages Monitoring Platform (ESMP) has gone live. EMA said the platform will enable marketing authorization holders and national competent authorities to “directly report information on supply, demand and availability of nationally and centrally authorized medicines during crises.” The use of ESMP will become mandatory on 2 February. Press Release

MedTech Europe listed the EU’s regulatory and legal frameworks as one of the region’s weaknesses. The trade group said the frameworks are a strength of the US and moderately positive for Asia Pacific. The EU’s “regulatory overlaps and unclear guidance on how they connect may drive medtech firms to regions with more agile regulatory frameworks,” the trade group said. Report

Euro Roundup: EMA sets July implementation date for ICH GCP guideline

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