The French Health Products Safety Agency (Afssaps) has replaced the Agence du médicament (Medical Products Agency) since March 1999. Its task: guarantee that the evaluation and control of health products (including drugs but also gene and cell therapy products for example, or organs, tissues and cells) are conducted in total independence and with the utmost scientific rigor.
When it appears that a product presents a health risk under normal conditions of use, the Agency can suspend, restrict or prohibit any activity involving this product by setting down special conditions of use.
The health products developed by Généthon are all destined to treat rare genetic diseases. They are submitted to the Orphan Drugs Committee before being evaluated by the European Medicinal Products Agency in London.
On 23rd April 2003, the European Commission published detailed guidance as a result of the 2001/20/CE directive on the conformity of legal and administrative dispositions, as well as regulations of member states regarding the application of Good Clinical Practices in conducting clinical trials on medicinal products for human use, also known as the clinical trial on a medicinal product directive.
They are recommendations drawn up to harmonize clinical trials procedures in the member states. All the links in this text will give you access to English documents from the European Commission’s website.
To know more
The European Agency for the Evaluation of Medicinal Products (EMEA) (In English)
This site provides information on the EMEA and on the procedure for orphan medicinal product designation in the European Union.
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