Europe – Global regulators confirm good safety profile of COVID-19 vaccines
EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).
Evidence from more than 13...
UK – BMS’ Sotyktu gets NICE green light for NHS use
The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults
Bristol Myers Squibb (BMS) has announced that the National Institute for Health and...
Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...
This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...
UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index...
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...
