FDA EU MRA and the Batch Testing Waiver Explained

The EU-US Mutual Recognition Agreement (MRA) is the arrangement under which European Union authorities and the US Food and Drug Administration recognise each other's good manufacturing practice inspections of medicines manufacturers, so that a facility inspected by one side does not have to be re-inspected by the other. Its most concrete commercial effect is the batch control testing waiver: since 11 July 2019 a Qualified Person in the EU may be relieved of the obligation to re-test each imported batch of a US-manufactured human medicine on EU territory.

That second sentence is the one that changes cost structures. Article 51(1)(b) of Directive 2001/83/EC normally requires that every production batch coming from a third country undergoes, inside a Member State, a full qualitative analysis, a quantitative analysis of at least all active substances, and whatever further testing the marketing authorisation demands. For a company shipping from a US site into the EU, that is a second complete analytical release on top of the one already performed in the United States. The MRA removes it, subject to conditions that are precise and worth knowing exactly.

This article covers the legal basis of the agreement, the verified timeline, what recognition of inspections means operationally, the conditions attached to the batch testing waiver, and what the MRA still does not cover.

What the EU-US MRA is, and where it comes from

The MRA is not a pharmaceutical instrument in origin. It is a trade agreement. The Agreement on mutual recognition between the European Community and the United States of America was signed in London on 18 May 1998 and published in the Official Journal L 31 of 4 February 1999. It covers seven sectors, including telecommunications equipment, electromagnetic compatibility, electrical safety, recreational craft and medical devices. Pharmaceutical GMP is one Sectoral Annex among several.

The Pharmaceutical Annex of 1998 was never fully implemented. What is operational today rests on the 2017 amendment to that Sectoral Annex, which builds on the original agreement and on years of joint pilot work on GMP inspections between the two regulatory systems.

Two legal layers therefore matter, and confusing them is the most common error in internal documentation:

• The MRA and its amended Sectoral Annex establish that the two authorities may rely on each other's inspections, and define the product scope in Article 4 and Appendix 3 of the Annex.
• Article 51(2) of Directive 2001/83/EC is the EU-side provision that converts that recognition into a testing waiver. The MRA does not itself waive testing. It supplies the "appropriate arrangements" that Article 51(2) requires before a Qualified Person may be relieved.

For veterinary medicines the equivalent EU provision is Article 97(7) of Regulation (EU) 2019/6.

The verified timeline

The operational phase did not arrive as a single event. It arrived as a sequence of capability confirmations, one national competent authority at a time, and the dates are documented by the European Medicines Agency, which announced the completion of mutual recognition for human medicines on 12 July 2019.

The scope extension to veterinary products was made through Joint Sectoral Committee Decision No 2536/2023, because veterinary products were outside the Annex from the beginning under the transitory provision in Article 20(2) of that Annex.

One nuance that regulatory teams should carry: the phrase "the MRA came into force in 2017" is true of the mutual recognition provisions and false of full coverage. Between November 2017 and July 2019 the agreement was live but partial, and which Member State authority had been confirmed determined what could be relied upon. Documents written during that window may reflect a state of play that no longer applies.

What mutual recognition of GMP inspections means in practice

In practice it means an inspection is performed once and accepted twice.

Since 1 November 2017 for human medicines, and 30 May 2023 for veterinary products, EU Member States do not duplicate inspections conducted by the FDA, and the FDA is expected not to duplicate inspections conducted by a recognised EU authority. For a manufacturer with a single site serving both markets, that removes a parallel inspection cycle, a parallel set of preparation and remediation workstreams, and a parallel calendar of authority visits.

Three qualifications keep this from being absolute.

First, both sides expressly reserve the right to inspect in each other's territory at any time. Recognition is the norm, not a legal prohibition on inspecting. For-cause inspections remain available.

Second, recognition attaches to authorities, not to companies. The relevant question is always whether the national competent authority that performed the inspection appears on the list of recognised authorities under Appendix 2 of the Sectoral Annex, which the European Commission publishes and keeps current.

Third, the reliance that took effect on 1 October 2025 is voluntary and conditional, not automatic. EU national competent authorities may rely on the outcome of FDA inspections conducted outside the United States following a case-by-case assessment and a risk-based approach, and may postpone an EU inspection that would otherwise be required during the assessment timelines of a marketing authorisation application or a variation. The EMA notes that supplying FDA inspection reports proactively, in the pre-submission phase or with the filing, makes this provision easier to apply. That is a concrete regulatory strategy item rather than a formality.

The batch control testing waiver under Article 51(2)

Article 51(1)(b) is the default rule and it is demanding. Every production batch coming from a third country must undergo, in a Member State, a full qualitative analysis, a quantitative analysis of at least all active substances, and all other tests or checks necessary to ensure quality in accordance with the marketing authorisation. Article 51(2) is the exception:

"In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls." Article 51(2), Directive 2001/83/EC

Read the wording closely. The relief is from carrying out the controls. It is not relief from certification. The Qualified Person still certifies the batch, still takes responsibility for that certification, and still has to verify that the conditions are met.

The EMA sets out those conditions explicitly. Since 11 July 2019, Qualified Persons in EU Member States are relieved of responsibility for carrying out the Article 51(1) controls on human medicines provided that:

• they have verified that the product was manufactured in the United States, and
• they have verified that the controls have been carried out in the United States, and
• each batch or lot is accompanied by a batch certificate issued by the manufacturer, aligned with the WHO certification scheme on the quality of medicinal products, certifying that the product complies with the requirements of the marketing authorisation and signed by the person responsible for releasing the batch or lot.

The same three conditions apply to veterinary medicines from 29 May 2026, with Article 97(7) of Regulation (EU) 2019/6 taking the place of Article 51.

Note what falls outside the waiver by construction. A product manufactured elsewhere and merely shipped from the United States is not covered, because the first condition fails. A batch tested outside the United States fails the second. A consignment without a compliant batch certificate fails the third, and that is the condition most often broken in day to day operations, since it depends on a document arriving correctly rather than on a regulatory status that was settled years ago.

What the MRA does not cover

The scope question is where accuracy matters most, because the answer has changed over time and stale summaries are abundant. Two categories must be kept apart: products excluded from the scope, and products not yet included in the operational scope but eligible for a later decision.

The distinction between the last three rows is not pedantry. Human vaccines and human-plasma-derived products, together with investigational medicinal products, are candidates the Joint Sectoral Committee may add to the operational scope after thorough assessment. Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of the Annex itself. Anyone planning around a future extension needs to know which list their product sits on.

The practical consequence is unambiguous for anyone importing a US-manufactured human vaccine or a plasma-derived medicine into the EU: full Article 51(1)(b) import testing still applies. There is no waiver, and there is no date on which one is promised.

What this means for a company supplying both markets

For an in-scope human medicine manufactured and tested in the United States and imported into the EU, the effect is a removed process step with real cost attached: an EU-based analytical release per batch, the laboratory capacity that supports it, the stability and reference standard logistics behind it, and the release lead time it adds to supply. Removing that step shortens time to market for each shipment and frees quality control capacity.

What replaces it is a documentation and verification discipline. The Qualified Person's obligation shifts from performing analysis to evidencing that the conditions of the waiver were satisfied for that batch: manufacture in the United States, testing in the United States, and a compliant, correctly signed batch certificate on file. Inspectors will look at that evidence trail, and a waiver applied without it is a deviation rather than an efficiency.

Three items belong on a quality system review as a result:

1. Scope mapping per product. Waiver eligibility is decided at product category level. A portfolio that mixes small molecules, biologics, a vaccine and an investigational product will have different answers within the same site.
2. Batch certificate control. The certificate is a condition, not paperwork. Its format, content and signatory should be specified in the quality agreement with the US site.
3. Inspection reliance strategy. Since 1 October 2025, FDA inspection outcomes from sites outside the United States can support EU assessment timelines, but only if the reports are put in front of the assessor. Providing them proactively at pre-submission is the actionable part.

Finally, an MRA is not a single relationship. The EU maintains mutual recognition agreements with several third countries, each with its own effective dates and product coverage, and Article 51(2) works the same way for each of them. A company sourcing from more than one of those countries is managing several scopes and several sets of conditions in parallel, and the answer for one says nothing about the answer for another.

Keeping track of what actually applies

The recurring difficulty here is not understanding the rule. It is knowing, for a specific product on a specific day, which authorisation, which manufacturing site, which scope and which national implementation govern it. That information sits across the European Commission's list of recognised authorities, the EMA's mutual recognition agreements pages, the current EMA questions and answers on the impact of the MRA, and national authority registers, none of which are joined up.

That fragmentation is the problem pharmazie.com was built for. It consolidates more than 25 pharmaceutical databases into a single search covering over 50,000 German products and more than 120,000 international products across 50+ countries, so that authorisation status, manufacturer and product data for the same substance can be compared across markets in one place rather than assembled from a dozen separate registers. DACON GmbH has maintained this data since 1989.

This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: July 2026.