Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory authorities to rely on defined elements of one another’s Good Manufacturing Practice (GMP) inspection systems. By reducing unnecessary duplication of inspections and, where applicable, batch testing, these agreements support international regulatory cooperation while maintaining oversight of medicinal product quality. However, mutual recognition is conditional. Its scope depends on the legal framework, the authorities involved, the products covered, the types of inspections concerned and the territorial provisions of each agreement.

GMP inspection cooperation and mutual recognition

Pharmaceutical manufacturers supplying several international markets may be subject to GMP inspections by multiple regulatory authorities. Although these inspections assess compliance with comparable quality standards, conducting separate inspections of the same manufacturing site can create duplication for both regulators and manufacturers.

Mutual Recognition Agreements provide a formal framework for addressing this issue. They allow participating authorities to rely on certain inspections conducted by their counterparts and, depending on the agreement, to recognise related regulatory documents or waive additional controls.

For a broader overview of how GMP inspection responsibilities are distributed among regulatory authorities, see our guide to the Global GMP inspection landscape.

An MRA does not establish a single international GMP inspection system. Each agreement has its own legal basis, product coverage, territorial scope and operational conditions.

What do GMP Mutual Recognition Agreements cover?

The term mutual recognition can suggest that two regulatory authorities automatically accept all decisions and documents issued by one another. In practice, recognition is more specific.

Depending on the agreement, its provisions may cover:

• GMP inspection results: one authority may rely on inspections conducted by a recognised authority in the other jurisdiction.
• GMP compliance documents: official certificates and other documents issued by recognised authorities may be accepted within the agreed scope.
• Batch testing: certain agreements allow the importing authority to waive additional batch testing when the required conditions are met.
• Regulatory information exchange: authorities may exchange inspection reports, information on quality defects and other relevant regulatory information.

A waiver of repeat batch testing should not be confused with batch release: the applicable batch-release requirements and responsibilities remain in place.

These elements are related but not interchangeable. Recognition of an inspection does not necessarily mean that every certificate, manufacturing authorisation or batch-release decision is automatically accepted.

The European Medicines Agency (EMA) identifies reliance on GMP inspections, information exchange and the waiver of batch testing on import as key elements of the EU’s MRA arrangements. The precise provisions differ between agreements.

International GMP inspection agreements and recognition arrangements

There is no single global MRA covering all major pharmaceutical markets. Instead, recognition operates through a network of bilateral and regional arrangements.

The European Union has operational GMP mutual recognition arrangements with Australia, Canada, Japan, New Zealand, Switzerland and the United States. These arrangements differ in their legal structures and product coverage.

The United States also has pharmaceutical GMP MRAs in force with the European Union, Switzerland and the United Kingdom.

The table provides an overview rather than a uniform description of legal coverage. Product categories, territorial applicability, inspection types and batch-certification provisions differ between agreements.

The EU–Canada pharmaceutical GMP arrangements are incorporated into the Comprehensive Economic and Trade Agreement (CETA). The EU–UK Trade and Cooperation Agreement also contains provisions for mutual recognition of GMP inspections between the two jurisdictions.

The EU–Israel Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) is a related but distinct legal framework. Although it includes pharmaceutical GMP provisions, it should not be treated as simply another conventional bilateral MRA.

The EMA overview of mutual recognition agreements provides a consolidated reference for the EU arrangements.

How international GMP inspection recognition works

An MRA does not normally provide unconditional recognition of every inspection conducted by every authority in the participating jurisdictions.

Recognition depends on the conditions established by the agreement. A central element is the assessment of the regulatory authority’s capability to conduct inspections in accordance with the applicable requirements.

The EU–US arrangement illustrates this approach.

Its pharmaceutical GMP sectoral annex entered into force on 1 November 2017 for human medicines. The agreement was subsequently extended to veterinary pharmaceuticals, with the relevant provisions entering into force on 30 May 2023.

The transition phase for veterinary products covered by the agreement ended on 29 May 2026. As a result, the arrangement became fully operational for covered veterinary products, subject to the applicable conditions, including verification of batch controls performed in the United States for products manufactured there and imported into the EU.

Recognition is based on the capability assessment of individual authorities rather than simply on their membership of the same regional regulatory system. The FDA maintains lists identifying recognised authorities and specifying the relevant product categories and limitations in its EU–US MRA information.

Other agreements follow comparable principles but have their own implementation arrangements.

The US–UK agreement entered into force on 1 January 2021 for human medicines. Its scope was expanded to include veterinary pharmaceuticals in September 2021.

The US–Switzerland agreement entered into force on 27 July 2023, following capability assessments by both parties.

These examples demonstrate why manufacturers should consult the relevant agreement and current recognition lists rather than assume that recognition applies uniformly across all products and inspection types.

GMP inspection exclusions and limitations under MRAs

The existence of an MRA does not mean that all pharmaceutical products, manufacturing activities or regulatory procedures are covered.

Depending on the agreement, exclusions or special conditions may apply to:

• advanced therapy medicinal products (ATMPs);
• human blood, plasma, tissues and organs;
• vaccines and plasma-derived medicinal products;
• veterinary immunological products;
• investigational medicinal products and clinical trial materials;
• particular types of inspections, including pre-approval inspections.

The exclusions differ between agreements. For example, ATMPs and veterinary immunological products are excluded from the scope of the US–UK and US–Switzerland arrangements. However, the EU–Switzerland agreement includes certain ATMPs within its product coverage.

The type of inspection is equally important. The capability determinations under the US–UK and US–Switzerland arrangements apply to routine surveillance inspections. It would therefore be incorrect to assume that every type of regulatory inspection is automatically recognised.

The distinction between mutual recognition, regulatory reliance and broader international inspection cooperation is also important. These mechanisms may complement one another, but they do not have the same legal effect.

We discuss their broader context in our article on the Global GMP inspection landscape.

Third-country manufacturing sites: where recognition becomes more complex

A particularly important question concerns manufacturing sites located outside the territories of the authorities participating in an MRA.

For example, a pharmaceutical company may manufacture a product in India or another third country and supply it to both the EU and the United States. The existence of an EU–US MRA does not mean that an inspection conducted by one party at any third-country site will automatically be recognised by the other.

However, territorial provisions are not identical across agreements.

The EU–Canada pharmaceutical GMP protocol allows inspections of manufacturing facilities in third countries by a regulatory authority of either party to be accepted under the relevant provisions. This arrangement has applied since 15 April 2021.

The EU–Switzerland framework also provides for recognition in certain third-country manufacturing situations, subject to additional conditions, including re-control of the product in one of the parties.

Under the EU–US arrangement, EU national competent authorities may accept official GMP documents issued by the FDA for manufacturing facilities located in third countries following a case-by-case assessment.

Consequently, product origin, manufacturing-site location, the authority conducting the inspection and the applicable agreement provisions must all be considered.

For manufacturers operating global supply chains, this distinction is particularly important: an agreement between two major markets should not be treated as a general guarantee that every inspection conducted anywhere in the world will be accepted.

GMP inspection recognition does not remove regulatory responsibility

Mutual recognition is intended to reduce unnecessary duplication, improve the use of inspection resources and support regulatory cooperation. It does not transfer regulatory responsibility from one authority to another.

An importing authority retains the ability to take action when there is evidence of a serious quality concern, when information received from its counterpart raises questions, or when the relevant circumstances fall outside the agreement’s scope.

The EU–US framework, for example, provides for reliance on inspections and the use of information obtained by recognised authorities. It does not prevent regulators from requiring further inspections or taking other action when necessary to protect public health.

The agreement therefore establishes a framework for regulatory reliance, not an unconditional obligation to accept every inspection outcome.

A network of agreements, not a global recognition system

Mutual recognition agreements are an important part of international pharmaceutical regulation. They allow participating authorities to rely on defined elements of one another’s GMP inspection systems, reduce duplication and, where the agreements provide for it, simplify certain controls on imported medicines.

However, recognition remains conditional. It depends on the legal framework, the authorities involved, the products and inspection types covered, and the territorial provisions of the individual agreement.

For pharmaceutical manufacturers, the practical lesson is clear: an MRA should never be treated as a general exemption from regulatory inspections. Its value lies in the specific recognition mechanisms it establishes — and understanding those mechanisms requires examining the relevant agreement and its current implementation status.