France Regulatory Issues
France Regulatory Issues
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The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system.
Publisher: Datamonitor Healthcare
- Description
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The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system. Most importantly, the creation of the Agence nationale des médicaments et des produits de santé (ANSM) has led to greater transparency in the operation of regulatory procedures, a willingness to take action against conflicts of interest, a clampdown on promotional activities, tougher criteria for drug approval, and more checks on drug safety profiles throughout the marketing lifecycle.
Table of Contents
4 EXECUTIVE SUMMARY
4 Key findings
5 DRUG APPROVAL AND REGULATORY PROCESSES
5 The ANSM is the new head of the French regulatory system
10 Drug approvals: the four regulatory routes offered under EU rules
12 Intellectual property – in France, patents are valid for 20 years
12 Data exclusivity issues in France – the 8+2+1 rule
13 Drug counterfeiting in France – traceability could help stem the tide
15 BIBLIOGRAPHY
List of figures
5 Figure 1: France – routes to obtaining market authorization
13 Figure 2: France – the 8+2+1 market exclusivity rule
Figure 1: France – routes to obtaining market authorization
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