Source: EURACTIV.com by Gerardo Fortuna
Pharmaceuticals and medical devices will be on the agenda of the third meeting of the Trade and Technology Council (TTC) between the US administration and the European Commission that will be held in Washington next 5 December.
Established in June 2021, the TTC is an initiative that provides a permanent platform for transatlantic cooperation to key global trade, economic, and technology issues.
In a draft of the final joint statement seen by EURACTIV, both partners say they will “work on considering the necessary steps to extend the scope of the EU-US Mutual Recognition Agreement annexe for Pharmaceutical Good Manufacturing Practices to include vaccines and plasma-derived pharmaceuticals for human use.”
Pharmaceutical Good Manufacturing Practices (GMPs) are the minimum standard that pharmaceutical manufacturers must meet in their production processes.
They are routinely inspected by the Food and Drugs Administration (FDA) and the European Medicines Agency (EMA), respectively, the US and the EU regulators for drugs and medical devices.
In 1998, the EU and the US signed a broad mutual recognition agreement (MRA) to ease part of the regulators’ burden by minimising duplicative inspectional efforts by the US and the EU.
An Annex of this agreement was devoted only to pharmaceuticals and was limited to inspections of facilities manufacturing human drug products.
However, the pharmaceutical Annex experienced some pitfalls in its implementation and needed a revision in 2017. At that time, the EU and the US were already evaluating the possibility of including other regulated products, such as veterinary products, human vaccines, and plasma-derived drugs.
If the draft is confirmed in the end, this will mean that the FDA may rely on the inspectional findings of EU member states in a European facility of vaccines or plasma-derived medicinal products that will export to the US.
Conversely, an EU member state may accept the FDA’s inspectional findings at a US facility that exports to an EU country.
