Key Takeaways
Thirteen authorities participating in the International Active Pharmaceutical Ingredient Inspection Programme reported 1,684 inspections at 936 API manufacturing sites between 2017 and 2024, and 69% of the sites were of interest to at least two authorities.
India accounted for 50% and China for 35% of the programme’s shared-interest API sites, concentrating overlapping regulatory attention in two countries.
Inspection reliance was reported for 107 of 644 shared-interest sites, or 17%, although inconsistent tracking may mean that authorities used reliance more often than the programme recorded.
The programme identified duplicate inspections at 32% of shared-interest sites, but noncompliance, different inspection scopes, and new risk information mean that not all repeated inspections were avoidable.
Expanding regulatory reliance will require timely inspection plans, usable reports, secure information sharing, and confidence that another authority’s work covers the relevant manufacturing operations and risks.
A Global Oversight System with Considerable Overlap
Between 2017 and 2024, 13 regulatory authorities participating in the International Active Pharmaceutical Ingredient Inspection Programme reported conducting 1,684 inspections at 936 active pharmaceutical ingredient (API) manufacturing sites. Of those sites, 644, or 69%, were of interest to at least two participating authorities. India accounted for 50% of these shared-interest sites, while China accounted for 35%, concentrating much of the programme’s overlapping regulatory attention in two countries.1
These figures illustrate why international inspection coordination has become important. When several authorities have an interest in the same manufacturing site, each faces a decision about whether to conduct its own inspection, participate in a coordinated inspection, or rely on work already performed or planned by another regulator. Repeating the same work can consume inspection capacity without adding commensurate regulatory value. Overlapping interest, however, does not necessarily mean that regulators require identical information.
The programme was established as a pilot in 2008 and has operated as a full programme since January 2011. Its goals are to strengthen collaboration and information sharing on good manufacturing practice (GMP) inspections of API manufacturers, reduce unnecessary duplication, and optimize inspection resources. Participating authorities agree to consider inspections conducted or planned by other members, request expansions of planned inspection scopes when appropriate, and conduct joint inspections when circumstances warrant them.
The latest European Medicines Agency (EMA) report confirms that regulators have established mechanisms for exchanging inspection plans and results, but documented reliance remains much less common than overlapping regulatory interest.1
What Regulatory Reliance Means
The World Health Organization (WHO) defines regulatory reliance as the practice of giving significant weight to assessments performed by another regulatory authority or trusted institution when reaching a decision. The relying authority remains independent, responsible, and accountable for that decision.2
Reliance does not require an authority to surrender control of its inspection program or accept another regulator’s conclusion automatically. It allows the authority to use existing regulatory work as evidence, determine whether that work answers its own questions, and decide whether an additional inspection would contribute information that is not already available.
Reliance also differs from formal recognition. The WHO describes recognition as the acceptance of another regulator’s decision, generally on the basis that the reference authority’s requirements are sufficient to meet those of the recognizing authority. Recognition may operate through a legally binding mutual recognition agreement (MRA), while reliance can occur through less formal mechanisms and does not eliminate the relying authority’s responsibility to reach its own conclusion.2
The European Union has formal GMP recognition arrangements with several regulatory partners, allowing authorities to rely on certain inspections, share inspection and quality information, and, where applicable, avoid duplicating regulatory activities. The European Commission categorizes its relationships with China and India as regulatory dialogues rather than MRAs.3 This distinction is significant because those countries contain the largest shares of API sites attracting interest from multiple programme members.1
Building Coordination into Inspection Planning
The International API Inspection Programme uses a Master List as its primary coordination tool. The list identifies API manufacturing sites outside participating authorities’ jurisdictions and records information about previous and planned inspections. Monthly teleconferences give participating authorities an additional opportunity to discuss upcoming inspections, inspection outcomes, noncompliant sites, and follow-up activities. These exchanges can inform inspection scheduling, changes in scope, reliance decisions, document exchanges, and possible joint inspections.
This planning function is as important as the exchange of completed reports. An authority that learns about another regulator’s inspection only after it has committed personnel, arranged travel, and notified the facility may have little practical ability to change course. Early information creates more options. The authority can review the planned scope, ask whether issues relevant to its jurisdiction can be incorporated, or wait for the resulting report before deciding whether its own inspection remains necessary.
The programme also facilitates early exchanges concerning sites found to be noncompliant. Within the limits of applicable confidentiality agreements, participating authorities have shared information before warning letters or formal GMP noncompliance statements became public. Members have also exchanged future inspection plans and, when needed, considered joint reinspection of a noncompliant manufacturer.
The Master List nevertheless remains a spreadsheet rather than a shared, continuously accessible inspection platform. During the 2017–2024 period, it was no longer uploaded to the protected module of EudraGMDP, although participating authorities continued to expand the information captured in it. The programme has not established a central repository for the Master List, inspection reports, and related documents because members have not identified a technical solution that meets all participating authorities’ security and legal requirements.
This leaves the programme dependent on the completeness and timing of information supplied by its members. If a planned inspection does not appear promptly, another authority may proceed without knowing that the site is already scheduled for inspection. Information sharing can reduce duplication only when it occurs early enough to affect regulatory planning.
The Reliance Gap
Regulatory interest overlapped at 644 sites, but reliance was reported for only 107 of them, or 17%. Most documented cases involved reviewing GMP certificates, inspection reports, or supporting records instead of conducting another inspection. In some cases, an authority postponed an inspection after learning that another regulator had already scheduled one.1
The comparison between 69% shared interest and 17% reported reliance should not be treated as a direct measure of missed opportunities. Some shared-interest sites may not be suitable for reliance because the authorities are evaluating different products, operations, or regulatory questions. The EMA also cautions that reliance was not tracked consistently throughout the reporting period, meaning that the 107-site figure may understate its actual use.1
Even with those qualifications, the figures expose a considerable distance between sharing information and acting on it. Authorities may know that another regulator has inspected a site but still be unable to determine whether the inspection addressed the relevant manufacturing operations or applied sufficiently comparable standards. They may receive a certificate confirming compliance without enough detail to evaluate the inspection’s scope. They may also be legally required to conduct an on-site inspection or lack a national procedure through which another authority’s findings can support their decision.
Guidance from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides a framework for assessing whether reliance is appropriate. The requesting regulator should have confidence in the capabilities of the authority responsible for oversight where the site is located and obtain at least a GMP certificate or, when certificates are not issued, the most recent inspection report containing a clear statement about the site’s compliance status. Additional information may include the inspection dates, scope, outcome, corrective and preventive action plan, planned reinspection date, site master file, and changes in ownership, personnel, products, or processes. These requirements make reliance an evidence-based regulatory assessment rather than a presumption that any recent inspection is sufficient.4
When Repeated Inspections Are Justified
The EMA report defines a duplicate inspection as an inspection of the same site by two or more authorities within 12 months. Its accompanying analysis indicates that 32% of the 644 shared-interest sites experienced this form of duplication. The report identifies 147 sites affected by inspections less than six months apart and another 57 affected within seven to 12 months.1
These figures identify repeated regulatory activity, but they do not establish that every additional inspection lacked value. Sites with noncompliant outcomes were more likely to undergo further inspections. From 2017 to 2024, 49 sites with more than one noncompliant outcome underwent 156 inspections, averaging 3.1 inspections per site. Among compliant sites affected by duplication, 155 sites underwent 353 inspections, averaging 2.3 per site.
A regulator confronted with evidence of serious noncompliance may need to confirm findings, evaluate corrective actions, or determine how the deficiencies affect products supplied to its jurisdiction. Another authority’s adverse finding can therefore create a reason to inspect rather than a reason to refrain from inspecting. Multiple inspections following noncompliance may represent intensified oversight, even when they also meet the programme’s definition of duplication.
Inspection scope can create another legitimate reason for returning to a recently inspected facility. A preapproval inspection focused on a particular API may not answer questions about another product manufactured at the same site. Authorities may apply different regulatory requirements or need evidence tied to separate applications. New information about the site can also make a previous inspection inadequate for a current decision.
Other repeated inspections appear more preventable. The EMA identifies incomplete or untimely information in the Master List as one cause of scheduling conflicts. Short-notice inspections can also make coordination impractical, particularly when an authority has limited time to determine whether another regulator’s plans could satisfy its needs. Administrative, logistical, and legal constraints may then prevent changes even after overlapping plans become known.
Reducing duplication requires distinguishing repetition caused by meaningful differences in risk or scope from repetition caused by information arriving too late, reports being unusable, or inspection plans remaining invisible to other regulators.
Why Inspection Reports Remain Difficult to Reuse
An inspection report must be accessible, sufficiently detailed, and legally shareable before another authority can rely on it. The international programme continues to encounter difficulties in all three areas.
Language is one obstacle. Reports may not be written in a language that another authority can readily use, and confidentiality requirements can prevent inspectors from submitting nonpublic material to online translation services. A report may therefore contain relevant evidence without being operationally accessible to the regulator that needs it.
Legal requirements can add further delays. An authority may need the manufacturer’s permission before sharing its inspection report. Specific sections may need to be anonymized or redacted to comply with national law. Completing those steps can take enough time to delay or prevent the report’s use in another authority’s inspection decision. In some cases, the relying authority may instead request the report directly from the manufacturing site.
The WHO identifies many of the same problems as broader barriers to regulatory reliance. These include limited access to complete assessments, confidentiality restrictions, the absence of a common language, translation costs, differences in national requirements and evidentiary standards, and inconsistent levels of detail in regulatory reports. The WHO recommends secure information-sharing channels and appropriate confidentiality arrangements when authorities exchange sensitive, nonpublic information.2
The EMA report recommends providing at least an English-language summary of each inspection report, together with clear information about its scope and extent. That would not eliminate the need to examine the underlying evidence, but it could allow another authority to determine more quickly whether the inspection is relevant to its needs. A secure central repository could further reduce the administrative friction involved in locating reports, obtaining permission, and confirming which version is authoritative.
The Role of Remote and Hybrid Inspections
The COVID-19 pandemic interrupted on-site inspection activity and accelerated the adoption of remote inspections and assessments. Participating authorities reported conducting 91 remote inspections during 2017–2024, representing 5% of the inspections recorded by the programme. No remote inspections were reported during the preceding period.1
Remote methods can conserve travel and inspection resources, but the EMA cautions that they cannot fully substitute for on-site inspection. Some participating authorities also operate under legal requirements that mandate a physical inspection. Remote methods are therefore most useful when their scope matches the regulatory question and when an authority can obtain adequate evidence without being present at the facility.
Joint inspections offer another route to shared oversight. The programme conducted 27 joint inspections at 25 sites during 2017–2024, equal to 4.2% of its shared-interest sites. The previous reporting period included 47 joint inspections at 43 sites, representing 10% of the shared-interest sites identified at that time. Joint inspections allow regulators to compare their approaches and produce evidence that multiple authorities can use, but they also require coordination of inspection scope, background information, financial arrangements, logistics, and participation by inspectors from different regions.
Collaborative hybrid inspections seek to retain the advantages of joint participation while limiting the number of authorities physically present. Under the International Coalition of Medicines Regulatory Authorities (ICMRA) model, one authority conducts the on-site inspection while inspectors from one or more additional authorities participate remotely. The authorities agree on the planned scope, coordinate their questions, and work toward a common regulatory outcome.5
The ICMRA Collaborative Hybrid Inspection Pilot completed three inspections covering different products and postapproval changes. Participating authorities reached consensus on inspection findings and compliance outcomes in all three cases, agreed on manufacturers’ corrective and preventive action plans, and reduced the number of separate authority inspections required for the participating manufacturers.6
The pilot also exposed a practical tradeoff. Although regulatory workloads were distributed across the participating inspection teams, survey responses indicated that the hybrid process significantly increased the workload for the manufacturing site compared with a standard single-authority inspection. The pilot’s three completed inspections provide evidence that the model can work, but they do not establish that it will be efficient for every site or inspection type.
Making Reliance More Usable
The programme’s next stage will depend on improving the quality, timing, and usability of the information exchanged among authorities. The EMA recommends recording the root causes of duplicate inspections, tracking reliance more consistently, improving the Master List, reconsidering existing European planning tools, and continuing to seek a secure central repository for inspection information and reports.
Better measurement is particularly important. A total count of duplicate inspections cannot show which inspections resulted from noncompliance, differing scopes, new risk information, short-notice scheduling, or failures in information exchange. A reliance count that omits decisions not to inspect cannot demonstrate how much regulatory work the programme has already avoided. More consistent tracking would show where reliance is functioning and where specific operational barriers continue to produce preventable repetition.
Standardized information about inspection scope, findings, corrective actions, and compliance status would make it easier for authorities to determine whether an existing inspection can support their own decisions. Joint work, report exchanges, common training, and repeated technical discussions can also build the institutional confidence required for reliance.
The most useful measure of progress will not be the elimination of repeated inspections. Noncompliance, new risk information, and materially different regulatory objectives can justify returning to a recently inspected site. The clearer opportunity lies in preventing inspections driven primarily by incomplete planning information, inaccessible reports, or uncertainty about what another authority examined.
More systematic reliance would allow regulators to direct limited inspection capacity toward unresolved risks and manufacturing operations that have not received adequate scrutiny. The governing question for each proposed inspection should be whether it will produce regulatory knowledge that the wider network does not already possess.
References
1. “Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017–2024.” European Medicines Agency. EMA/202541/2026. 7 Sep. 2026.
2. “Good Reliance Practices in the Regulation of Medical Products: High Level Principles and Considerations.” WHO Technical Report Series. 1033: 237–267 (2021).
3. “International Cooperation on Pharmaceuticals.” European Commission, Directorate-General for Health and Food Safety. Accessed 21 Sep. 2026.
4. “Guidance: GMP Inspection Reliance.” Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. PI 048-1. 1 Jun. 2018.
5. “Inspection Expectations for ICMRA Collaborative Hybrid Inspection Pilot (CHIP) Participants.” International Coalition of Medicines Regulatory Authorities. Version 1. 18 Aug. 2023.
6. “ICMRA Collaborative Hybrid Inspection Pilot (CHIP) Summary Report.” International Coalition of Medicines Regulatory Authorities. 5 Mar. 2025.
