Regulatory affairs consulting in France: our specific services
What are the specificities in France in terms of regulatory affairs?
In France, the pharmaceutical industry is closely monitored by ANSM (Agence nationale de sécurité du médicament et des produits de santé – National Agency for Medicines and Health Products Safety) that oversee pharmaceutical surveillance.
In addition to the European regulation this surveillance is carried out on the basis of French national legislation that defines which information must be provided to government Agencies, who are in charge of authorizing the marketing of drugs.
Consequently, understanding French local regulatory requirements is crucial for the success of a biopharmaceutical company planning to launch medicinal products in France or with an existing French organization.
French Legislation
The EU’s rules drive the national guidelines but in France, the Public Health Code and the Social Security Code contain most of the legislation pertaining to medical and health products.
ANSM – A Regulatory authority
The National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé) regulates human health products. As a public agency, under the authority of the Health Ministry, ANSM oversee monitoring and regulating health products, including:
- Medicinal products
- Medical devices and in vitro diagnostic medical devices
- Biological products of human origin (labile blood products, organs, tissues, cells, gene and cell therapy products) and related therapeutic products
The competence of the ANSM also applies to cosmetic products and tattoo products.
The ANSM collaborates with:
- National Agency for Food, Environmental and Occupational Health and Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail).
- National Authority for Health (Haute Autorité de Santé) – HAS.
- Economic Committee for Health Products (Comité économique des produits de santé) – CEPS
- Is responsible for the scientific and technical evaluation of medicines and biological products, issues marketing authorizations and contributes to European work for the centralized or mutual recognition procedures. It ensures a constant and regular re-evaluation of the benefit/risk ratio through continuous monitoring of foreseeable or unexpected adverse drug reactions.
- Ensures the implementation of vigilance systems for health products intended for human use and cosmetic products. It evaluates and exploits vigilance reports with a view to prevention and, if necessary, takes corrective or preventive measures.
- For medical devices, in vitro diagnostic medical devices, and cosmetics, intervenes after the commercialization by an evaluation of the benefit/risk within the framework of the market surveillance of DM, or following reports of vigilance within the framework of the materialovigilance and cosmetovigilance system.
- Ensures laboratory controls, either in a national context or in a European coordination context: the release of batches of vaccines and blood-derived medicinal products and all health products of various types (biochemical, immunological, physicochemical, biological, microbiological, immunohematological).
- Carries out inspections for all health products under its authority, including at the international level. These inspections concern industrial or institutional operators who manufacture, import or distribute health products, or who conduct clinical or non-clinical trials or who carry out pharmacovigilance activities. They concern the control of compliance with legislative and regulatory provisions.
What is the role of the French Regulatory Affairs Department?
The Regulatory affairs (known in France as “affaires réglementaires”) team for a company in France will have a key role to play, thanks to its knowledge and expertise in a continuously and fast evolving regulatory environment.
Regulatory Affairs are responsible of local regulatory compliance with French regulations and procedures.
In this context, it must be able to answer questions from French institutions on specific issues related to authorizations or on the socio-economic impact of a medicine, for example.
In addition to its expertise in regulatory affairs, the department will also be involved in external relations with French stakeholders
The French Regulatory Affairs team must therefore meet multiple expectations:
- An expert assessment on the quality of the regulatory dossier
- An understanding of legislation and practices implemented in France and Europe
- Capacity to anticipate on future changes that may be proposed by various stakeholders (authorities or industry), such as reference texts on pharmaceuticals, medical devices.
The Regulatory Affairs Department will need to rely on specific skills and training to have the ability to assume responsibility and manage regulatory processes.
To meet these expectations, BlueReg offers valuable and unique specificities:
- Regulatory Affairs experts with experience in various departments of the pharmaceutical industry, BlueReg has over 50 regulatory affairs consultants who have worked within major French pharmaceutical companies for at least between 5 and 10 years.
This experience ensures a strong knowledge of the principles of pharmaceutical management, from development through to marketing authorization and commercialization.
- A Regulatory Affairs Department with international experience
BlueReg has been able to gain extensive expertise at a European level. It is currently working for companies headquartered in Europe, North America and ROW. In this way, it has been able to bring its regulatory affairs consulting services in France in line with European and international standards.
This expertise makes BlueReg the partner of choice for companies who have a project to develop on both an international scale and in France.
Our regulatory affairs expertise for the French market
A dedicated team of highly qualified consultants and project manager providing services in France. The team have:
- Significant hands-on industry experience and broad expertise in national Regulatory Affairs, Quality Management and Pharmacovigilance.
- Varied and flexible skills, ranging from strategic consulting to operational execution, as well as leading and project management.
The team works with many clients, from biotech start-ups to large pharma companies looking for local expertise or specific services for France. The team have a highly successful track record of delivering all projects, from the simple to the complex.
Our Latest Engagements
- Review and submission of local promotional materials for pharmaceutical products and medical devices – ensuring it follows French local regulatory requirements (regulatory compliance)
- Preparation of early access dossier (“accès précoce”) applications for an Orphan Drug
- Handling of all local regulatory activities for a portfolio of pharmaceutical products
- support for the preparation of MAA (Marketing Authorization Application) dossier for a new pharmaceutical product
- Supporting a US company in obtaining an “Exploitant” status from the French National Agency for the Safety of Medicines and Health Products (ANSM) for their newly created affiliate in France. This included providing strategic advice to the client, setting up a specific Quality Management System (QMS) and preparing the “Exploitant” application filed to ANSM.
Regulatory Affairs France
Our regulatory affairs consulting services in France are designed to support clients during all the product development, registration, and commercialization phases (launch, communications, lifecycle management).
Please note that BlueReg is also able to provide regulatory solutions in all European countries. We support many biopharmaceutical companies from various location.
Interested to know more about our services, don’t hesitate to contact us!
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The BlueReg team have a highly successful track record of delivering all French market specific services, from the simple to the complex providing expert advice as well as hands-on operational support.
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