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Drug Registration Process in France

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Drug Registration Process in France

Drug Registration Process in France

 

MOH- Ministry of Social Affairs and Health

Regulatory Authority

Agency for Medicines and Health Products Safety (ANSM)

Regulatory Website

https://ansm.sante.fr/

Local Representative Required

Yes

The drug registration process in France involves a comprehensive series of steps to ensure the safety, efficacy, and quality of pharmaceutical products before they are approved for use in the country. The regulatory authority responsible for overseeing this process is the French National Agency for Medicines and Health Products Safety (ANSM), which collaborates with the European Medicines Agency (EMA) for certain aspects of drug evaluation.

Drug Approval Process

  • National Procedure

The national procedure (NP) authorizes medications that are not covered by the centralized procedure or those were approved prior to the EMA’s formation. Manufacturers who want to get market authorization in particular EU member states can find it helpful. Applications in this procedure are examined by the relevant EU member state authorities. Every EU member state has its own national protocol.

  • Centralized Procedure

Manufacturers can submit a single Market Authorization Application (MAA) to the EMA through the consolidated approach. Manufacturers who intend to sell their goods both inside the EU and in Iceland, Liechtenstein, and Norway—members of the European Economic Area (EEA)—will find the CP helpful. 

Following European Commission (EC) approval, producers are permitted to sell their products to healthcare professionals through a centralized mechanism that comes under Regulation (EC) 726/2004.

  • Mutual Recognition Procedure

Market authorization issued in one EU member state is recognized in other EU member states under the Mutual Recognition Procedure (MRP). Only in cases where the manufacturer has already received market permission in an EU nation is MRP applicable. The Directive 2001/83/EC establishes the rules for market authorization through MRP. 

It is necessary to make sure that all MRP applications are comparable if they are sent to multiple EU nations. The nation reviewing the application is referred to as the Reference Member State, and it is its responsibility to inform the other relevant Member States of the application’s status.

  • Decentralized Procedure

The Decentralized Procedure (DP) can be used for medications that are not yet approved in the European Union. Manufacturers of these medications may submit simultaneous permission applications to several EU member states. This process is governed by Directive 2004/27/EC. Any state that is only one member of the DP may decide to evaluate the application on its own.

When the drug registration is taking place in the France then the type of the procedure used will be the national procedure.

Process of Registration

1.Preparation of the Dossier- The Dossier is prepared in the eCTD format which contains the Information about the Drug product. Different modules are their module 1 to module 5 carrying different information about the drug product. The Applicant need to prepare the Dossier.

2.Submission of Marketing Authorization Application- The pharmaceutical business submits a Marketing Authorization Application to the ANSM following the conclusion of clinical studies. Comprehensive information about the drug’s effectiveness, safety, and quality from preclinical and clinical research is included in this application.

3.ANSM Review – The MAA dossier is carefully examined by the ANSM. A group of specialists examines the information provided to make sure it complies with legal requirements and determines the medication’s risk-benefit ratio. 

4.Approval phase – ANSM decides whether to provide marketing authorization following a thorough assessment. The choice could be to approve, reject, or ask for more information or research.

  1. Post-Authorization Surveillance: Pharmacovigilance systems are used to continuously monitor the safety and efficacy of approved drugs. To maintain continuous safety, adverse occurrences and side effects are recorded and examined.
  1. Regulatory Compliance: To keep their authorization, pharmaceutical businesses must abide by strict laws regarding labeling, packaging, and manufacturing standards. Any modifications to the manufacturing process or medicine formulation necessitate regulatory authority.           

Generic Drug Approval Process

1.   Preparation of Application– A Marketing Authorization Application (MAA) is prepared by the generic medication producer and submitted to the ANSM. Data proving the generic medication’s quality, safety, efficacy, and bioequivalence are included in the application.

  1. Bioequivalence Studies -An essential step in the approval process for generic drugs are bioequivalence studies. In order to guarantee comparable pharmacokinetic characteristics, such as absorption, distribution, metabolism, and elimination, these investigations contrast the reference medication with the generic medication.
  2. Standards for Manufacturing and Quality-The reference medication’s production and quality criteria must be met by the generic version as well. Following Good Manufacturing Practice (GMP) guidelines is part of this.
  3. Assessment conducted by ANSM-The ANSM examines the MAA and assesses the regulatory and scientific information that the generic medicine producer has provided. The agency determines if the safety, effectiveness, and quality of the generic medication are comparable to those of the reference medication.

Documents Required for Drug Registration

     1. Cover Letter

     2. Application Form

     3. Declaration of Patent and Data exclusivity

     4. Certified Copy of Marketing Authorization

     5. Originally signed confirmation of identical dossier.

     6. Dossier in the format of eCTD.

Registration Timeline

12-18 Months

License validity 

5 years

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