Europe – Guidance for industry to prevent and mitigate medicine shortages
EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .
Medicine...
France – Topiramate et risques chez les enfants exposés pendant la grossesse : modification...
Actualisation du 2 mai 2023
Depuis le 2 mai 2023, pour les filles, adolescentes, femmes en âge de procréer et femme enceintes :
La prescription de...
Europe – EMA annual report 2022 published
EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12...
Review of hydroxyprogesterone started
EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the...
Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...
The following legal obligations apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are...
USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves
Les AINS, tels que l’ibuprofène, le kétoprofène, sont parmi les médicaments les plus utilisés en automédication comme antalgiques (anti-douleurs) ou antipyrétiques (anti-fièvre) chez les...
UK – Otsuka’s Lupkynis receives NICE green light
Recommendation applies across England and Wales and the treatment is available now
Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...
