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The European Union and the United States have concluded an agreement for mutual recognition of inspections carried out on the drug manufacturing sites in their respective territories. This agreement enters its operational phase, the ANSM is among the first health authorities recognized by the US Food and Drug Administration (US FDA).

The 1 November 2017 marks the beginning of mutual recognition of inspections of human medicine manufacturing sites between the United States and eight European Union member states, including France.

The agreement was the subject of nearly 3 years of preparatory work between European and US authorities. ANSM was particularly involved in this, notably by participating in the audit and evaluation of the US FDA in 2015 in order to ensure that the evaluation inspections of GMP were equivalent. to European practices.

The ANSM has also worked hard, in conjunction with its French institutional partners, the European Commission and the US FDA to position France among the countries to be recognized in the first wave. As such, it has been evaluated by the US FDA during the year 2017 and is among the 8 first recognized Member States. The remaining Member States will be evaluated by the US FDA gradually until July 2019.

This major agreement between the European Union and the US FDA updates the historical text of 1998 and strengthens the relations on both sides of the Atlantic to better rationalize the resources devoted to inspections to deploy more resources in other parts of the world where active substances and medicines are produced.

It will provide patients with access to quality, safe and effective medicines regardless of where they are manufactured and will facilitate the prioritization of inspections for sites with the highest risks.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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