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Download ANSM: A Guide to the French National Agency for the Safety of Medicines and Health Products
If you are interested in health products, such as medicines, medical devices, cosmetics, and biologics, you may want to download ANSM, the app that gives you access to the information and services provided by the French National Agency for the Safety of Medicines and Health Products (ANSM).
ANSM is a public institution that regulates and monitors the safety and efficacy of health products in France. It also promotes access to therapeutic innovation and collaborates with European and international health organisations.
In this article, we will explain what ANSM is and what it does, what are its features and benefits, and what are some alternatives to ANSM. We hope that this guide will help you understand better the role and value of ANSM in the field of health products.
What is ANSM and what does it do?
ANSM stands for Agence nationale de sécurité du médicament et des produits de santé, which translates to National Agency for the Safety of Medicines and Health Products. It was created in 2012 as a successor to the French Agency for the Safety of Health Products (AFSSAPS), following a major health scandal involving a weight-loss drug called Mediator.
ANSM is a public institution under the supervision of the Ministry of Health. It has about 1,000 employees, including pharmacists, doctors, biologists, engineers, lawyers, economists, statisticians, and inspectors. It has its headquarters in Saint-Denis, near Paris, and several regional offices and laboratories across France.
ANSM's missions and activities
The main missions of ANSM are to:
authorise the approval of new medicines and biologics
monitor all health products throughout their life cycle
study the impacts of their use
collect and analyse side effect reports
engage in product quality control at its laboratories
inspect manufacturing and distribution sites
To fulfil these missions, ANSM carries out various activities, such as:
evaluating the quality, safety, efficacy, performance, benefit-risk balance, added therapeutic value, public health interest, economic impact, environmental impact, ethical aspects, social acceptability, patient preference, patient-reported outcomes, real-world evidence, etc. of health products
issuing authorisations or opinions for clinical trials, marketing authorisations (MA), temporary authorisations for use (ATU), early access authorisations (AP), compassionate use authorisations (AAC), etc.
classifying health products according to their status (medicinal product, medical device, cosmetic product, biological product) or their risk level (class I to III for medical devices)
setting standards or guidelines for good manufacturing practices (GMP), good distribution practices (GDP), good clinical practices (GCP), good pharmacovigilance practices (GVP), good laboratory practices (GLP), etc.
monitoring the safety, quality, and efficacy of health products through pharmacovigilance, materiovigilance, cosmetovigilance, biovigilance, addictovigilance, hemovigilance, etc.
managing health risks and crises related to health products
recalling or suspending health products that pose a threat to public health
sanctioning or prosecuting violations of the regulations on health products
informing and educating health professionals and the public about the proper use of health products
ANSM's role in European and international cooperation
ANSM is not only active at the national level, but also at the European and international level. It participates in various networks and initiatives that aim to harmonise and improve the regulation and monitoring of health products.
Some examples of ANSM's involvement in European and international cooperation are:
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download ansm annual report
download ansm strategic plan
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download ansm therapeutic areas and products
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download ansm transparency and open data policy
download ansm legal texts and references
download ansm frequently asked questions (FAQ)
ANSM is a member of the Heads of Medicines Agencies (HMA), a network of the national competent authorities (NCAs) responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area (EEA).
ANSM is a member of the European Medicines Agency (EMA), an agency of the European Union (EU) that is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
ANSM is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary, executive-level entity that provides strategic coordination, advocacy, and leadership among medicines regulatory authorities.
ANSM is a member of the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world who aim to harmonise and improve the safety and performance of medical devices.
ANSM is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a project that brings together regulatory authorities and pharmaceutical industry representatives from different regions to discuss scientific and technical aspects of drug registration.
ANSM is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organisation that aims to harmonise inspection procedures worldwide by developing common standards in the field of good manufacturing practices (GMP).
What are the features of ANSM?
ANSM offers various features that make it easier for stakeholders to access information and services related to health products. Some of these features are:
ANSM's website and online services
The ANSM website () is a comprehensive source of information about ANSM's missions, activities, organisation, publications, news, events, etc. It also provides access to various online services, such as:
A database of all authorised medicines in France, with their summary of product characteristics (SPC), patient information leaflet (PIL), public assessment report (PAR), etc.
A database of all medical devices in France, with their classification, intended use, manufacturer, etc.
A database of all clinical trials authorised by ANSM in France, with their protocol, sponsor, status, results, etc.
A database of all adverse events reported to ANSM by health professionals or patients, with their description, causality assessment, outcome, etc.
A portal for submitting applications or notifications to ANSM for various procedures, such as clinical trials, marketing authorisations, temporary authorisations for use, early access authorisations, compassionate use authorisations, etc.
A portal for reporting adverse events to ANSM, either as a health professional or as a patient.
A portal for accessing the ANSM app, which allows users to scan the barcode of a medicine or a medical device and get information about its characteristics, indications, contraindications, warnings, interactions, side effects, etc.
ANSM's innovation and guidance desk (GIO)
The innovation and guidance desk (GIO) is a service offered by ANSM to support and advise developers of innovative health products. The GIO provides a single point of contact for any questions or requests related to the development, evaluation, authorisation, or monitoring of innovative health products.
The GIO can help developers with various aspects, such as:
identifying the regulatory framework and the requirements applicable to their product
clarifying the classification and the status of their product
providing scientific and technical guidance on the design and conduct of clinical trials
facilitating the submission and the processing of applications or notifications to ANSM
coordinating with other national or European authorities or organisations
promoting dialogue and collaboration between stakeholders
ANSM's assessment doctrine and methods
The assessment doctrine and methods (DAM) is a set of principles and tools that guide ANSM's evaluation of heal