9662 results
-
List item
ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline (updated)
Last updated: 06/10/2023 -
List item
Frequently asked questions (updated)
Last updated: 07/02/2023 -
List item
ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline (new)
Last updated: 07/02/2023 -
List item
Committee for Orphan Medicinal Products (COMP) (updated)
Last updated: 07/02/2023 -
List item
Scientific publications (updated)
Last updated: 07/02/2023 -
List item
Vaccine Monitoring Platform (new)
Last updated: 07/02/2023 -
List item
Website outages and upgrades (updated)
Last updated: 07/02/2023 -
List item
Development of the Clinical Trials Information System (updated)
Last updated: 07/02/2023 -
List item
Union Product Database (updated)
Last updated: 06/02/2023 -
List item
PRAC: Agendas, minutes and highlights (updated)
Last updated: 06/02/2023 -
List item
News: EMA update on shortages of antibiotics in the EU (updated)
Last updated: 06/02/2023 -
List item
News: Actions to support the development of medicines for children (new)
PDCO, Last updated: 06/02/2023 -
List item
Newsletters (updated)
Last updated: 06/02/2023 -
List item
ICH Q9 Quality risk management - Scientific guideline (updated)
Last updated: 06/02/2023 -
List item
PRAC recommendations on safety signals (updated)
Last updated: 06/02/2023 -
List item
Quality: non-immunologicals (updated)
Last updated: 03/02/2023 -
List item
Procurement (updated)
Last updated: 03/02/2023 -
List item
News: Public consultation on a multi-stakeholder platform to improve clinical trials in the EU (new)
Last updated: 03/02/2023 -
List item
News: EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair (new)
HMPC, Last updated: 03/02/2023 -
List item
Plasma master file certificates (updated)
Last updated: 02/02/2023 -
List item
Crisis preparedness and management (updated)
Last updated: 02/02/2023 -
List item
News: A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies (new)
Last updated: 02/02/2023 -
List item
Variations not requiring assessment (veterinary medicines) (updated)
Last updated: 01/02/2023 -
List item
Clinical evaluation of new vaccines - Scientific guideline (updated)
Last updated: 01/02/2023 -
List item
PRIME: priority medicines (updated)
Last updated: 01/02/2023