Ansm.sante.fr

Annual Report 2022 I 2

WEBIn 2022, with the gradual end of the Covid-19 health crisis, the Agency steadfastly pursued its role of protecting citizens. Faced with global supply tensions that have affected …

Actived: 4 days ago

URL: https://ansm.sante.fr/uploads/2023/10/13/ra-uk-ansm-version-13-octobre.pdf

Clinical trials on medicinal products e Fast-Track procedure

WEBMaking health innovation accessible faster for patients is a priority that the government has posted in the CSIS 2018 (Strategic Council of Health Industries) and that the ANSM, …

Category: Health Go Health

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR …

WEBMoreover, public health needs may require quick actions or re-prioritisation of operations. The ultimate aim of the EU legislation on medicinal products is to ensure a high level of …

Category: Health Go Health

Sécurité du médicament à l'hopital

WEBAprès les actes invasifs et les infections liées aux soins, les médicaments sont la troisième cause d’événements indésirables graves (EIG) : 60 000 à 130 000 par an dont 15 à 60 …

Category: Health Go Health

PRACTICAL INFORMATION GUIDE FOR APPLICANTS

WEBCTs on a health product (other than a MD), in particular cosmetics and medicinal products, including advanced therapy medicinal products, cell therapy preparations, organs, …

Category: Health Go Health

ANNUAL REPORT 2021

WEBHealth Strategy (SNS), defined by the government for the 2018-2022 period and contributes to the first priority commitment of the “My Health 2022” project: “Promoting …

Category: Health Go Health

ANSM’S GUIDELINE

WEB89 impact on safety of care and patient health. 90 91 In recent years, there has been a tremendous growth in healthcare-specific software and mobile 92 applications. Such …

Category: Health Go Health

FRENCH HAEMOVIGILANCE ANNUAL REPORT YEAR 2022 …

WEBCreated by the Public Health Code law nr. 93-5 (dated January 4, 1993), French haemovigilance is a key pillar to ensure the quality and safety of transfusion and blood …

Category: Health Go Health

Dossier thématique

WEBDiagnostic et prise en charge des infections à SARS-Cov2 dans les essais cliniques. L'ANSM rappelle que la prise en charge des patients COVID-19 en France …

Category: Health Go Health

Dossier thématique

WEBInformation pour les professionnels de santé. Une fiche récapitulant les effets indésirables pouvant survenir après la vaccination est mise à disposition pour chaque vaccin …

Category: Health Go Health

Ethylene oxide-sterilised medical devices in neonatology and …

WEBit is also necessary for the user health care establishment to have information on the residual . 36. quantities of carcinogenic substances for these devices, to enable it to …

Category: Health Go Health

Consultation for a medical device incorporating an ancillary

WEBThis guide concerns medical devices, including active implantable medical devices, which incorporate an ancillary medicinal substance. According to the safety and performance …

Category: Medical Go Health

Pharmacovigilance information for pharmaceutical companies …

WEBas listed in articles L 5121-1 and R. 5121-150 of the French Public Health Code and received by exploitant pharmaceutical companies. These ICSRs can be spontaneous or …

Category: Health Go Health

Scope of application

WEBbehalf of the holder pursuant to Article R. 5124-2 3° of the French Public Health Code; - accompanied by a version in Word. Important: The statement of compliance must be …

Category: Health Go Health

Dossier thématique

WEBL’antibiorésistance. L’antibiorésistance ou résistance aux antibiotiques, est la capacité d’une bactérie à développer des mécanismes de défense qui lui permettent …

Category: Health Go Health