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THE PULSE OF GLOBAL PHARMA REGULATION
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EUROPE · EMA INTELLIGENCE
EU edition · 2025-10
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REGULATORY · EMA
Harmonized Standards for Medical Devices Adopted
The European Commission issued Implementing Decision (EU) 2025/2078 on 17 October 2025, adopting four harmonized standards for surgical clothing, drapes, medical face masks, and sterilizers under the MDR.
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ARTICLE
New EU Implementing Regulation on Medical Technologies
On 17 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2086, establishing procedural rules and templates for medical technology evaluations under HTA Regulation (EU) 2021/2282. This regulation introduces International Reliance Routes...
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NEWS
Capability Confirmation for EU States
FDA confirmed the capability of nine EU states for human and veterinary GMP inspections, including Sweden, Latvia, and Germany, between June 2023 and September 2025.
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NEWS
EU-USA MRA Batch Testing Waiver
The EU-USA Mutual Recognition Agreement allows for a batch testing waiver for human medicines, operational since July 2019, while the veterinary waiver is pending full EU state recognitions.
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NEWS
Assessments Under EU-USA MRA
As of October 2025, assessments are ongoing for Malta and Croatia under the EU-USA MRA for veterinary product manufacturer inspections.
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Key Statistics
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9
EU States Confirmed for GMP Inspections
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4
New Standards Adopted Under MDR
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MHRA Actions Against Businesses
Year-to-date
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Notable Resources
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GUIDANCE · MHRA
Latest guidance for manufacturers on conducting clinical investigations of medical devices.
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BLOG · Parexel
Analysis of strategic implications for drug developers under the new EU Pharma Package.
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Official sources
- https://www.ema.europa.eu/en/documents/other/qa-impact-eu-usa-mutual-recognition-agreement-marketing-authorisation-applications-relevant-variations-revised-1st-october-2025_en.pdf
- https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-mra-between-european-union-united-states-1st-october-2025_en.pdf
- https://assets.publishing.service.gov.uk/media/68e3b0abef1c2f72bc1e4e17/Guidance_for_mfrs_on_clinical_investigations-October_2025.pdf
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Trusted by manufacturing, regulatory affairs, and quality teams across Europe.
EU
· Edition 2025-10
· B2B pharma intelligence, generated and reviewed by editors.
© NovaPharmaNews. Trusted pharmaceutical intelligence covering FDA, EMA, NMPA, and PMDA regulatory developments across global markets.
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