Medicinal products - Latest updates

Commission proposes new measures for the better lifecycle management of medicine authorisations

Factsheet - Access to medicines in all Member States

Factsheet - Incentives to steer innovation and achieve public health objectives

Factsheet - Addressing shortages of medicines and ensuring security of supply

Factsheet - Steering innovation to address unmet medical needs

Summary record - 101st meeting of the Pharmaceutical Committee (23 November 2023)

Medicines for children 2022 annual report

Deadline for submission extended - Open calls for expressions of interest: EMA COMP and EMA PRAC Committees

Registration and agenda - Biosimilar medicines - Multistakeholder Event (13 December 2023)

Agenda - 101st meeting of the Pharmaceutical Committee (23 November 2023)

First electronic product information (ePIs) published for selected human medicines

Updated document - ICH Q9 Quality Risk Management

Updated document - Questions & Answers : Clinical Trials Regulation (EU) No 536/2014

Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

Phasing out of extraordinary COVID-19 regulatory flexibilities

Agenda - Stakeholder workshop on the “Transparency Directive” (Directive 89/105/EEC) (29 June 2023)

EU-US agreement on GMP inspections brings high quality medicines faster to animals

European Health Union: Commission proposes pharmaceuticals reform for
more accessible, affordable and innovative medicines

Questions and Answers on the pharmaceutical legislation