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Search results (10)
PRIME eligibility requests: 2024 deadlines for submission and timetable for assessment
English (EN) (114.35 KB - PDF)
PRIME eligibility requests: 2023 deadlines for submission and timetable for assessment
English (EN) (141.01 KB - PDF)
PRIME eligibility requests: 2022 deadlines for submission and timetable for assessment
English (EN) (146.35 KB - PDF)
EMA Regulatory Science to 2025 - Strategic reflection
English (EN) (4.8 MB - PDF)
Qualification opinion on eSource Direct Data Capture (DDC)
English (EN) (1.23 MB - PDF)
Draft EMA Regulatory Science to 2025 - Strategic reflection
The Regulatory Science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough.”
Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.
English (EN) (3.8 MB - PDF)
Draft qualification opinion on eSource Direct Data Capture (DDC)
English (EN) (415.85 KB - PDF)
Qualification Opinion on The European Cystic Fibrosis Society Patient Registry (ECFSPR) and CF Pharmaco-epidemiology Studies
English (EN) (1.1 MB - PDF)
EudraVigilance stakeholder change management plan
English (EN) (1.64 MB - PDF)
Qualification opinion ILSI / HESI submission of novel renal biomarkers for toxicity
The European Medicines Agency qualification process is a new, voluntary, scientific pathway leading to
either a CHMP opinion or a Scientific Advice on innovative methods or drug development tools. It
includes qualification of biomarkers developed by consortia, networks, public/private partnerships,
learned societies or pharmaceutical industry for a specific intended use in pharmaceuticals R&D.
English (EN) (1.25 MB - PDF)