France – Trois bases de données médicamenteuses obtiennent l’agrément version 3 de la HAS
La Haute autorité de santé (HAS) a accordé aux bases de données sur les médicaments Thériaque, Claude Bernard et Vidal un agrément version n°3...
Europe – EMA seeks feedback on clinical development of vaccines for immunocompromised people
The European Medicines Agency (EMA) has published a draft concept paper on the clinical development of vaccines in immunocompromised individuals. EMA is seeking feedback...
International – The subjectivity of starting materials in the era of harmonization
Regulatory starting materials (RSMs) represent the starting point of drug substance synthesis from which subsequent steps are carried out under good manufacturing practice (GMP)...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.
The CHMP adopted a positive opinion for Omjjara* (momelotinib),...
USA – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older...
USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme...
International – ICH adopts guidelines on viral safety evaluation and analytical method development
The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...
Europe – First electronic product information (ePI) published for selected human medicines
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across...
USA – FDA finalizes guidance on real-time review of oncology drugs
The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new...
