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.
The Public Health Code and the Social Security Code contain most of the legislation and decrees pertaining to medical and health products. The EU’s rules drive the national guidelines.
Public agencies, under the authority of the Health Ministry, oversee monitoring and regulating health products, including:
- Medical products
- Food supplements
The National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé)
regulates human health 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) – CEP
- Monitors clinical research taking place in France.
- Monitors manufacturing, distribution, importation, exportation, advertisement and sale of health products (drug and medical device) and authorizes companies and their facilities to carry out these operations.
- Manage Marketing authorizations approval and registrations of medical products
- Monitors the safety of health products (drug & medical device) through pharmacovigilance
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 (political representatives, members of academic and professional associations).
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 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
- 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:
Promotional Material Review in France
BlueReg peut vous accompagner pour du conseil ou de la gestion opérationnelle afin de garantir la conformité de toutes vos opérations avec les exigences qui s’appliquent en France
Regulatory affairs consulting in France
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.
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Looking for help with regulatory activities in the United States? BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).
Product Quality Review
BlueReg has an experienced team for Product Quality Review (PQR) writing including CMC, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.
Market Access France
BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France.
BlueReg assists companies to plan and submit any necessary changes to existing marketing authorizations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg Linkedin page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
BlueReg can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
Regulatory Affairs Consulting EU
Our team composed of global experts from the pharmaceutical industry provides the necessary support to help you succeed in all regulatory aspects of life sciences in Europe from development, registration through to commercialization.
Early Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
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