Euro Roundup: EMA opens door to reliance on FDA GMP inspections conducted outside the US
The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration’s (FDA) findings from inspections of facilities outside the US.In 2023, EMA said the provision of the EU-USA Mutual Recognition Agreement that covered overseas inspections was yet to become operational. At that time, EU good manufacturing practice (GMP) inspectorates were evaluating the provision under a pilot program.
EMA shared the outcome of the pilot program last week. The findings led the EU GMP/GDP Inspectors Working Group to enable the voluntary acceptance of FDA inspections of overseas sites from 1 October.
“Following a case-by-case assessment and the application of a risk-based approach EU national competent authorities may decide to apply reliance and to postpone the conduct of an EU inspection that would normally be required during the assessment timelines of a marketing authorization application or variation,” EMA said.
Applicants can proactively provide FDA inspection reports in the pre-submission phase or with filings for authorization or variations to facilitate the use of the reliance provision.
EMA Q&A
Clock-stop extensions shorten after EMA starts strictly implementing guideline
The duration of clock-stop extensions at EMA dropped 18% in the first half of 2025. EMA said the improvement followed efforts to reinforce best practices for requests for the extensions from companies.
Officials stop the clock on medicine evaluations while applicants prepare responses to questions from the regulatory authority. The clock resumes once the applicant has filed its responses. Over the first half of 2025, extensions lasted an average of 150 days, compared to 182 days last year. The reduction could cut the time it takes for new medicines to reach patients.
In its mid-year report, EMA said the average clock stop for new active substances and biosimilars in the second quarter of 2025 was 132.97 days. The agency is aiming to keep the average extension below 180 days this year. The last time EMA beat that target in the second quarter was 2021, when the average extension was 168 days. The average clock stop climbed to 239 days in the second quarter of 2024.
EMA set up the Group for Internal Rules on Extensions of Clock Stops (GIREX) to reverse the trend of extensions lasting longer. GIREX introduced a systematic discussion of all clock-stop extension requests at EMA’s advanced therapy and human medicine committees.
The agency said the steps led to better harmonized extensions and a return to the strict implementation of the 2009 guideline on clock-stop extensions. Those changes translated into a reduction in the time to approval for marketing authorization applications in the first half of 2025.
Work to further improve the process is ongoing, with EMA aiming to ensure a change of culture about the number of questions raised during evaluation. The agency plans to focus on key questions, rather than “nice to haves,” and has made workbooks for clinical and quality assessors. Workshops are planned for the second half of 2025.
EMA’s Pre-submission Interaction Group project is seeking to drive further improvements. The agency said it is looking to “fundamentally” reshape its pre-submission interactions with rapporteurs and applicants. EMA’s goal is to avoid premature submissions and enhance submission predictability. The agency attempted unsuccessfully to improve the predictability of submissions in 2022 and 2023.
Press Release, EMA Report
EDQM seeks feedback on plans to add glycol adulteration section to monographs
The European Directorate for the Quality of Medicines and HealthCare (EDQM) is holding a consultation into a quantification method for suspected adulteration with ethylene glycol (EG) and diethylene glycol (DEG).
Children have died after consuming syrups that were contaminated with EG and DEG, potentially deadly chemicals that can be illicitly substituted for pharmaceutical-grade excipients. The deaths led the European Pharmacopoeia Commission (EPC) to order the development of methods for detecting and quantifying the contaminants in the widely used excipients sorbitol and maltitol.
The EPC order has led to the drafting of a “Potential adulteration” section in four sorbitol and maltitol monographs. The proposed section describes a gas chromatography method to be used for the detection of harmful levels of EG and DEG when adulteration is suspected.
EDQM said this is the first time that a group of experts has proposed to add a “Potential adulteration” section as described in the European Pharmacopoeia (Ph. Eur.) General Notices.
Under the Ph. Eur., potential adulteration sections can apply to “monographs on substances for which an incident has occurred or which are at risk of deliberate contamination.” The Pharmacopoeia states that the requirements “apply to the whole supply chain, from manufacturers to users.”
The proposals are open for feedback until the end of the year.
EDQM Notice
MHRA touts halving of clinical trial approval times after reforming process
The UK Medicines and Healthcare products Regulatory Agency (MHRA) said its reforms have more than halved the time it takes to approve clinical trials.
In a press release, MHRA said approval times fell from 91 days to 41 days. By law, MHRA should provide its final decision within 60 days of receiving the original request. MHRA attributed the reduction in approval times to “AI and reforms.”
The press release is based on a paper published in the British Journal of Clinical Pharmacology that found MHRA completed the first review within the statutory timelines for 99% of filings. The paper makes no mention of AI, focusing instead on the impact of the risk-proportionate approach that MHRA adopted in 2023.
MHRA shared details of the paper the day before disclosing plans to deepen collaboration with the US on medical technology regulation. The details came from a conversation between leaders from MHRA and FDA at an industry event. MHRA used the event to discuss plans “to strengthen regulatory alignment and reciprocity.”
Press Release, Paper, More
MedTech Europe submits wishlist for planned European Innovation Act
MedTech Europe has responded to a call for evidence on the planned European Innovation Act, setting out the steps it wants authorities to take to support the medical device industry.
The European Commission launched the consultation in July to collect feedback on problems such as administrative burdens that are hindering the growth of companies. The consultation, which closed late last week, covered all industries. Trade group MedTech Europe conveyed the positions of device and diagnostics businesses in its response to the Commission.
MedTech Europe is calling for the Commission to streamline pathways from research to market without substituting or delaying “urgently needed sectoral reforms.” The trade group named the regulations on medical devices and diagnostics and environmental simplification measures as areas that need reforming urgently.
The request is part of a broader call for the Commission to design the Innovation Act around other rules. MedTech Europe said “regulatory fragmentation and complexity, overlapping horizontal/sectoral rules, and capacity bottlenecks are eroding Europe’s attractiveness for innovation and delaying patient access.” The trade group sees an opportunity for the new legislation to address those issues.
“We call on the European Commission to engage in interdepartmental dialogues to ensure that the European Innovation Act further enables existing simplification efforts (digital, environmental) and planned sectoral reform (MDR/IVDR planned for late 2025) to deliver concrete mechanisms which reduce burden and align frameworks,” MedTech Europe said.
Press Release
Other News:
The European Commission is seeking feedback on European Health Data Space texts. Public Consultation
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.