Euro Roundup: EMA to make ACT EU permanent in 2027
In January, the European Medicines Agency (EMA) will make permanent a pilot project that helps sponsors prepare clinical trial applications.
EMA launched the Accelerating Clinical Trials in the EU (ACT EU) advice pilot in 2024. As part of the program, sponsors receive technical and regulatory support before they submit an application through the Clinical Trials Information System (CTIS). The Heads of Medicines Agencies have coordinated the pilot through their Clinical Trials Coordination Group.
Making the initiative permanent will support the incoming Biotech Act by helping sponsors navigate the EU clinical trials framework more effectively, EMA said. The news comes one week after EMA said the European Commission wants it to urgently advance preparations for the Biotech Act.
The pilot has helped sponsors file higher-quality applications by providing consolidated feedback from the Member States concerned on key pre-submission topics, EMA said. Prior to the pilot, sponsors could receive technical and regulatory support only at the national level from the Member State responsible for evaluating their applications.
ACT EU will manage applications submitted under the pilot until the end of 2026. EMA will provide updated guidance and templates for the permanent initiative at the start of next year.
EMA plans to publish a final report summarizing lessons from approximately 30 pilot applications by the end of the year.
EMA starts consultation into showing therapeutic equivalence for nasal products
EMA is seeking feedback on its draft requirements for demonstrating therapeutic equivalence for nasal products.
The draft guideline applies to medicinal products containing the same active moiety that act locally in the nasal mucosa or have systemic activity. EMA named xylometazoline and naloxone as examples of locally and systemically acting drugs, respectively. The agency designed the draft to complement its existing guideline on the quality of drugs delivered to the lungs or the nasal mucosa.
Therapeutic equivalence implies that the efficacy and safety profile of the test and reference products are sufficiently comparable that they will not differ clinically. The term applies to both in vitro and in vivo data collection.
EMA’s draft provides a stepwise approach to demonstrating therapeutic equivalence between locally acting nasal products. Focusing on abridged applications, the guideline provides principles for showing therapeutic equivalence in vitro or using pharmacokinetics (PK).
Companies can meet the equivalence requirements, despite some in vitro differences, by using PK to demonstrate equivalent systemic exposure, local absorption, and deposition. EMA sees systemic exposure as a surrogate for safety and local absorption and deposition as a surrogate for efficacy. Pharmacodynamic or clinical endpoints are seldom sensitive enough to show therapeutic equivalence, EMA said.
Developers of nasal medicinal products with systemic effects should generally demonstrate therapeutic equivalence through an in vivo study. A waiver based on in vitro data is possible for solutions if certain criteria are met. EMA will not accept pharmacodynamic or clinical data unless the company can confirm bioequivalence.
Swissmedic moves to simplify GMP compliance processes for foreign manufacturers
The Swiss Agency for Therapeutic Products (Swissmedic) has acted to simplify good manufacturing practice (GMP) compliance for foreign manufacturers.
Swissmedic took these actions after meeting with industry associations to clarify unresolved issues. Based on the conversation about authorization applications, Swissmedic and the industry associations jointly developed specific solutions and approaches to solve the problems.
The updates are intended to simplify processes and make them more efficient. The effectiveness of the measures and clarifications will be fully assessable in a few months, Swissmedic said.
Given the importance of the subject, Swissmedic published the minutes of the meeting, deviating from its usual practice. The minutes show that Swissmedic shared examples of its reasons for rejections. Later, industry representatives presented the implementation issues and existing uncertainties that they face, as well as the impact those problems have on affected companies.
Industry groups shared details of how Swissmedic’s procedures affect different manufacturers. Contract manufacturing organizations, companies in countries with mutual recognition agreements, and a US producer shared details of their pain points.
Swissmedic's response included a commitment to conduct an internal evaluation to improve its interactions with marketing authorization holders in complex cases. The industry groups also called for timely feedback from Swissmedic and a holistic review of all submitted documents. Most issues were resolved at the meeting, and solutions exist for the remaining pain points, Swissmedic said.
Team-NB supports involving qualified notified body experts in EMA expert panels
A notified body trade group has backed the involvement of qualified notified body experts in EMA expert panels.
The trade group supported the plan in a position paper, arguing it would make better use of validated scientific, technical, and regulatory expertise. Experts should participate as individual professionals, not as representatives of their notified body, and both they and their employer must consent, Team-NB said.
Several proposals for reforming the European medtech regulations reflect that the absence of notified bodies in the expert panel procedure is perceived as a weakness of the system, the trade group said. However, the current legislative framework blocks notified body employees from sharing their regulatory and technical expertise.
Team-NB said the restriction reflects concerns that employment by a notified body creates an unacceptable conflict of interest. However, the trade group views the restriction as “overly conservative and not sufficiently reflective of the legally defined role of notified bodies” as independent groups.
The European Commission has proposed allowing notified body experts to participate in all procedures, except clinical evaluation consultation processes. Team-NB called the proposal “an important first step.” However, the trade group wants the Commission to go further to make it workable in practice for notified body experts to participate.
Team-NB set out procedural considerations in its position paper, providing principles intended to safeguard the impartiality and independence of notified bodies when their staff is involved in expert panels. The trade group argued that its measure would close the gap in the current advice schemes for manufacturers and strengthen regulatory predictability.
Other news
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on real-world evidence (RWE). The standards and guidelines provide principles to support the generation, assessment, and regulatory use of real-world data (RWD) and RWE. The document collates existing guidelines and provides further information on topics such as the definition of RWD and RWE. MHRA Guidance
The European Pharmacopoeia Commission has approved the creation of a working party focused on quality standards for 3D-printed medicinal products. The working party will assess the relevance and potential impact of the technologies on the European Pharmacopoeia. Other objectives include identifying areas where new texts are needed and where existing texts should be revised. Press Release
MHRA has summarized its position on patient-reported outcomes (PROs) for digital mental health technologies. The summary is intended to provide developers with resources to integrate PROs into evidence generation and routine monitoring of the technologies. MHRA Summary
