Inspection responsibilities depend on a manufacturing site’s location, activities, target markets and applicable regulatory procedures — not simply on the name of a medicines agency. Understanding these factors helps manufacturers identify which authorities may inspect their facilities and how existing inspection results may be used by other regulators.

Consider a manufacturing site producing an active pharmaceutical ingredient (API) for customers in Europe, China and India, while finished products made from that API are also registered in the Eurasian Economic Union (EAEU). For this site, “who will inspect us?” is not a single question. Nor is it the same as asking which regulator matters most to the business. This guide explains how inspection responsibilities are distributed, how market access affects inspection planning, and why regulatory inspections and customer audits must be treated separately. It is the opening article in the series Mapping Inspection Systems: Who Conducts Inspections — and Who Coordinates Them.

Scope: The article focuses on GMP inspections of manufacturers of medicinal products and APIs. Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and pharmacovigilance follow related but distinct regulatory procedures.

Five Questions About Your Site

Before consulting lists of regulators, answer five questions. Together, they provide a starting point for identifying the authorities that may inspect your facility.

1. Where Is the Site Located?

The country in which a manufacturing site operates provides the baseline for national oversight, including applicable licensing, routine supervision and responses to potential compliance concerns. Export-related inspection requirements may apply in addition to this national framework.

2. Which Markets Does the Site Serve?

Each target market may introduce additional inspection requirements. A marketing authorisation application can trigger an inspection before approval, while products already supplied to a market remain subject to applicable ongoing supervision. However, access to a market does not automatically mean that its regulator will conduct an on-site inspection. Depending on the jurisdiction and applicable arrangements, authorities may use inspection information generated by other regulators.

3. What Does the Site Manufacture?

The site’s activities influence the applicable requirements and the scope of inspection. Relevant factors include API synthesis, finished dosage form manufacturing, sterile production, biological products and on-site quality control laboratories.

In Japan, GMP inspection responsibilities are allocated according to the product, the type of inspection and whether the manufacturing site is domestic or overseas. PMDA is responsible for inspections of overseas manufacturing sites, while prefectural authorities conduct certain inspections of domestic sites. PMDA also handles specified categories of higher-risk products and other defined inspection procedures. See the PMDA’s official GMP information and guidance for foreign manufacturers.

4. What May Trigger an Inspection?

The reason for an inspection affects its scope and timing. Possible triggers include:

• A marketing authorisation application;
• Routine, risk-based regulatory supervision;
• A complaint, recall or suspected quality problem;
• Verification of corrective and preventive actions;
• Renewal of a licence, certificate or registration, where applicable.

The applicable procedure determines whether an inspection is required and whether it will be conducted on-site or through another permitted assessment format.

5. What Previous Inspection Results Are Available?

Existing GMP certificates, inspection reports and participation in applicable mutual recognition or reliance arrangements may influence whether another authority needs to conduct its own inspection. The effect depends on the jurisdiction, the scope of the previous inspection and the conditions of the relevant arrangement.

A single manufacturing site may therefore face several overlapping oversight regimes and customer audit requirements. National supervision, export-market inspections and customer audits coexist; none should automatically be treated as a substitute for the others.

Five Roles: Why “The Regulator” Is Not a Complete Answer

Statements such as “FDA will inspect us” or “EMA will inspect us” can conceal several distinct regulatory functions.

United States

The FDA’s Office of Inspections and Investigations (OII) leads the agency’s field inspection and investigation activities. Within the pharmaceutical inspection system, the Office of Human and Animal Drug Inspectorate (OHADI), which is part of OII, works with the relevant FDA product centres, including the Center for Drug Evaluation and Research (CDER).

The allocation of responsibilities between OII and CDER depends on the inspection type and applicable procedure. Under the FDA’s updated human-drug inspection operating model, CDER conducts pre-approval evaluations to determine whether a pre-approval inspection or a remote regulatory assessment is needed. OII generally leads the resulting pre-approval inspections, with CDER participation where appropriate. Other inspection types follow their own allocation and decision-making arrangements. The assessment of findings and any regulatory action involve the appropriate functions within the agency.

European Union

The European Medicines Agency (EMA) does not ordinarily conduct GMP inspections itself. National competent authorities carry out inspections, while EMA coordinates relevant activities and supports harmonisation across the European regulatory network. The responsibilities associated with a particular site depend on the applicable procedure and market arrangements.

For centrally authorised products, the EMA coordinates GMP inspections and requests that the inspection be carried out by a national authority. The updated procedure for coordinating GMP inspections for centrally authorised products was adopted in April 2026 and entered into force on 10 September 2026. It clarifies, among other matters, the arrangements for inspections that do not require a supporting authority.

The EMA explains this division of responsibilities in its official compliance overview. The EudraGMDP database contains GMP certificates and statements of non-compliance, among other regulatory information.

Japan

GMP inspections are conducted by PMDA and prefectural authorities, with responsibilities depending on the product, procedure and site location. In particular, PMDA is responsible for GMP inspections of overseas manufacturing sites. For domestic sites, PMDA handles specified categories of products and inspections, while prefectural authorities conduct other inspections within their remit. MHLW retains its respective administrative and policy responsibilities under the Japanese system.

The practical lesson is straightforward: knowing an agency’s name is not enough. Manufacturers need to understand how inspection, coordination and decision-making functions are allocated in each jurisdiction.

Overview of Major Inspection Systems

The following table provides an orientation to the principal systems discussed in this series. It is not a substitute for checking the applicable procedure for a specific product and site.

For China, the NMPA’s explanatory notes on GMP certificates confirm that certification certificates ceased to be issued under the revised Drug Administration Law, effective 1 December 2019. The absence of such certificates should not be interpreted as the absence of GMP oversight.

PIC/S: Cooperation Is Not Automatic Recognition

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is not a medicines regulator and does not represent a separate product market. It is a non-binding cooperation arrangement between regulatory authorities working to harmonise GMP inspection standards, develop guidance, train inspectors and facilitate information exchange. As of 2026, PIC/S comprises 57 participating authorities worldwide.

Its cooperation framework supports greater consistency and mutual confidence, but PIC/S membership alone does not require participating authorities to recognise one another’s GMP certificates or inspection results. The PIC/S FAQ expressly distinguishes participation in the Scheme from the mutual recognition obligations that apply to parties to the Pharmaceutical Inspection Convention. Recognition must therefore be checked against the relevant legal arrangement and the receiving authority’s requirements.

See the official PIC/S introduction.

Basis, Format and Notification: Three Dimensions of an Inspection

Inspection terminology is not fully interchangeable between jurisdictions. For planning purposes, it is useful to distinguish three separate dimensions.

Basis: Why Is the Inspection Taking Place?

• Pre-approval: associated with a marketing authorisation application.
• Routine surveillance: scheduled or risk-based regulatory oversight.
• For-cause: prompted by a complaint, recall, suspected quality problem or other signal.
• Follow-up: intended to verify corrective actions or address previously identified concerns.
• Other procedure-specific inspections: where required by the relevant licensing, certification or registration framework.

Format: How Is the Inspection Conducted?

Depending on the applicable rules and risk assessment, the format may be on-site, remote or desk-based, involving the review of documents and other available evidence. A remote regulatory assessment, a document-based assessment and an on-site inspection are not necessarily equivalent regulatory procedures. Their legal basis and effect must be checked in the relevant jurisdiction.

Notification: When Is the Site Informed?

An inspection may be announced in advance, conducted at short notice or performed without prior announcement where the applicable rules permit it. The notification arrangements affect the site’s preparation and should be confirmed for each relevant jurisdiction.

Manufacturers should not automatically transfer an inspection classification from one jurisdiction to another. The legal basis, format and notification requirements must be checked under the procedure governing the specific inspection.

Regulatory Inspection and Customer Audit Are Not the Same

In addition to regulators, pharmaceutical manufacturing sites may be audited by customers, marketing authorisation holders (MAHs), distributors and procurement organisations. These audits serve different purposes from regulatory inspections.

A customer audit does not automatically replace a regulatory inspection, and the reverse is also true. A regulator may, however, require a marketing authorisation holder to conduct or oversee supplier audits under applicable rules. Such an audit remains distinct from a state inspection.

Reliance on Other Inspections: Why a Market Does Not Always Mean a Visit

Before estimating the number of inspections a site may face, manufacturers should examine whether an authority can use the results of an inspection performed by another regulator. Three mechanisms are particularly important.

Harmonisation and cooperation: PIC/S supports common standards, inspector training and cooperation between participating authorities. It does not, by itself, create a general obligation to recognise inspection results or GMP certificates issued by other participating authorities.

Mutual recognition agreements (MRAs): These are legally binding arrangements between jurisdictions. Their effect depends on the agreement’s scope, participating parties and applicable conditions. The EMA provides information on GMP mutual recognition agreements.

Regulatory reliance: An authority may use another regulator’s inspection work to inform its own assessment and decisions where the relevant framework allows it. WHO Prequalification, for example, may rely on the outputs of inspections conducted by national medicines regulatory authorities operating to standards and stringency equivalent to those of WHO Prequalification. This does not mean that every previous inspection will automatically be accepted; the relevance, scope and quality of the inspection information remain important.

These mechanisms can influence inspection planning, but their application is conditional. Before assuming that a previous inspection will be accepted, a manufacturer should verify the scope, validity and recognition conditions relevant to each target market.

The Site Inspection Profile

A practical way to organise the information is to create an internal Site Inspection Profile. This is a planning tool, not an official regulatory form. It helps the site identify potential inspecting authorities and the questions that remain unresolved.

The completed profile provides a provisional map of possible inspecting authorities and highlights the questions that still need to be resolved. The answers depend on the organisation of each inspectorate, the procedure that initiates an inspection, the documents produced and the mechanisms through which other authorities may use its results.

The following articles in this series will examine individual inspection systems in greater detail, beginning with the Eurasian Economic Union.

Next article in this series: FDA inspections: who will inspect your site — and who decides the outcome?