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.
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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:
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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:
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 health products. The DAM aims to ensure that ANSM's assessment is consistent, transparent, rigorous, and adapted to the specificities of each product.
The DAM covers various aspects, such as:
the definition and the application of the criteria for evaluating the quality, safety, efficacy, performance, benefit-risk balance, added therapeutic value, public health interest, etc. of health products
the use of appropriate methods and sources of evidence for assessing health products, such as randomised controlled trials (RCTs), meta-analyses, observational studies, real-world data (RWD), real-world evidence (RWE), patient-reported outcomes (PROs), etc.
the involvement of external experts and stakeholders in the assessment process, such as scientific committees, working groups, advisory boards, patient representatives, etc.
the communication and dissemination of the assessment results and recommendations to the public and the health professionals
What are the benefits of ANSM?
ANSM provides various benefits to the stakeholders involved in the field of health products. Some of these benefits are:
ANSM ensures the safety and quality of health products
One of the main benefits of ANSM is that it ensures that all health products available in France meet high standards of safety and quality. ANSM monitors all health products throughout their life cycle, from their development to their use. It collects and analyses data on their impacts and side effects. It intervenes in case of any health risk or crisis related to health products. It protects public health by recalling or suspending any health product that poses a threat.
ANSM facilitates access to therapeutic innovation
Another benefit of ANSM is that it facilitates access to therapeutic innovation for patients who need it. ANSM supports and advises developers of innovative health products. It provides fast-track procedures for authorising clinical trials or marketing new medicines or biologics. It grants temporary or early access authorisations for patients who have no alternative treatment options. It promotes research and development in the field of health products.
ANSM provides transparency and information to stakeholders
A third benefit of ANSM is that it provides transparency and information to stakeholders about health products. ANSM publishes all its decisions, opinions, reports, guidelines, etc. on its website. It informs and educates health professionals and the public about the proper use of health products. It involves external experts and stakeholders in its assessment process. It responds to any questions or requests from stakeholders.
What are the alternatives to ANSM?
ANSM is not the only authority that regulates and monitors health products. There are other alternatives to ANSM at the national, European, or international level. Some of these alternatives are:
Other national competent authorities in the EU
In each member state of the EU, there is a national competent authority (NCA) that is responsible for regulating and monitoring health products in its territory. For example, in Germany there is the Federal Institute for Drugs and Medical Devices (BfArM), in the UK there is the Medicines and Healthcare products Regulatory Agency (MHRA), in Spain there is the Spanish Agency of Medicines and Medical Devices (AEMPS), etc.
These NCAs have similar missions and activities as ANSM, but they may have different procedures, requirements, or criteria for evaluating and authorising health products. They also cooperate with each other and with the EMA through various networks and initiatives.
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) is an agency of the EU that is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. It works with the NCAs and other EU institutions to ensure that all medicines available in the EU are safe, effective, and of high quality.
The EMA has various roles and tasks, such as:
coordinating the centralised procedure for authorising new medicines or biologics that are intended for use in more than one member state of the EU
providing scientific advice and guidance to developers of innovative medicines or biologics
monitoring the safety of medicines through pharmacovigilance and risk management activities
managing health emergencies or crises related to medicines
promoting research and innovation in the field of medicines
informing and communicating with stakeholders about medicines
Other international health organisations
Besides ANSM and other NCAs or EMA, there are other international health organisations that regulate and monitor health products at the global level. Some of these organisations are:
The World Health Organization (WHO), a specialised agency of the United Nations (UN) that is responsible for directing and coordinating international health within the UN system. It provides leadership, guidance, standards, norms, data, evidence, etc. on various health issues, including health products.
The International Conference on Harmonisation of Technical Requirements for Registration of 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.
The International Organization for Standardization (ISO), an independent, non-governmental organisation that develops and publishes international standards for various fields, including health products.
Conclusion and FAQs
In conclusion, 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. ANSM offers various features that make it easier for stakeholders to access information and services related to health products. ANSM provides various benefits to stakeholders, such as ensuring the safety and quality of health products, facilitating access to therapeutic innovation, and providing transparency and information to stakeholders. ANSM is not the only authority that regulates and monitors health products. There are other alternatives to ANSM at the national, European, or international level.
If you want to learn more about ANSM, you can download its app or visit its website. You can also contact its innovation and guidance desk if you have any questions or requests related to innovative health products. You can also check out some of the frequently asked questions (FAQs) below:
What is the difference between ANSM and EMA?
ANSM is a national competent authority (NCA) that regulates and monitors health products in France. EMA is an agency of the EU that coordinates the scientific evaluation, supervision, and safety monitoring of medicines in the EU. Both ANSM and EMA work together and share information and expertise on various aspects of health products regulation and monitoring.
How can I download ANSM app?
You can download ANSM app from the Google Play Store or the Apple App Store. The app is free and compatible with Android and iOS devices. The app allows you to scan the barcode of a medicine or a medical device and get information about its characteristics, indications, contraindications, warnings, interactions, side effects, etc.
How can I report an adverse event to ANSM?
You can report an adverse event to ANSM either as a health professional or as a patient. You can use the online portal on the ANSM website or the ANSM app to fill in a form and submit your report. You can also contact your regional pharmacovigilance center (CRPV) by phone or email. You can find the contact details of your CRPV on the ANSM website.
How can I apply for a clinical trial or a marketing authorisation to ANSM?
You can apply for a clinical trial or a marketing authorisation to ANSM by using the online portal on the ANSM website. You will need to create an account and provide the required documents and information for your application. You will also need to pay a fee for your application. You can find the details of the application procedures and the fees on the ANSM website.
How can I contact ANSM innovation and guidance desk (GIO)?
You can contact ANSM innovation and guidance desk (GIO) by email at . You can also call them at +33 (0)1 55 87 40 00. The GIO is available from Monday to Friday, from 9:00 am to 5:00 pm. The GIO can help you with any questions or requests related to the development, evaluation, authorisation, or monitoring of innovative health products. 44f88ac181
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