Europe – Procedural advice on publication of information on withdrawals of applications for marketing...
This paper describes the publication of information on the withdrawals of marketing authorisation applications for human medicinal products and withdrawals of applications for variations/extensions...
Europe – Use of real-world evidence in regulatory decision making – EMA publishes review...
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting.
The committee recommended granting a marketing...
Europe – ACT EU: creating a better environment for clinical trials through collaboration
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU)....
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
Europe – European Health Union: EU steps up the fight against antimicrobial resistance
The Commission welcomes today's adoption by the Council of the European Union of the Commission's proposal to strengthen EU action against antimicrobial resistance (AMR).
Announced together with...
Europe – Guidance on paediatric submissions
The following guidance outlines the main steps to take to prepare for submission, and a list of documents required for the main1 types of...
Europe – EMA Management Board: highlights of June 2023 meeting
The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the...
UK – NICE nod for AstraZeneca’s Lynparza
Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer
The National Institute for Health and Care Excellence (NICE) has recommended...
Europe – EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2...
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations...
