US, EU Aim to Strengthen Medical Inspection Cooperation

The 2 entities reached an agreement allowing for the full sharing of trade secret information relating to medicine inspections.

The European Commission (EC), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) have agreed to and signed a new confidentiality commitment, allowing the FDA to share non-public and commercially confidential information with EU regulators.

Shareable information includes trade secret information relating to medicine inspections, aiming to allow growth in the ongoing mutual recognition of inspections of medicine manufacturers between the 2 entities.

This new confidentiality agreement “formally [recognizes] that FDA's EU counterparts have the authority and demonstrated [the] ability to protect the relevant information,” according to an EMA press release.

The US and EU originally reached an agreement to recognize the others’ medical inspections of manufacturers in February 2017, which gave the FDA and EMA the ability to better use “inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety, and efficacy of all medicines, no matter where they have been produced,” according to a press release at the time.

The sharing of full inspection reports will now be allowed, which should open the door for regulators to utilize their counterpart’s findings while making their own inspections. This will, according to the EMA, allow for a “focus on manufacturing sites of higher risk.”

Since 2003, the EU and the US have had confidentiality agreements, but this marks the first time that a complete exchange of information will be allowed. The goal of the new agreement will be to strengthen the US-EU relationship, as well as create a more efficient use of inspection resources.

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