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...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

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...

Switzerland – New COVID-19 vaccine successfully tested

Rocketvax and researchers at the University of Basel have linked up to develop a new approach for a COVID-19 vaccine. Researchers led by Professor Thomas...

UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...

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