{"id":27401,"date":"2026-09-18T10:16:22","date_gmt":"2026-09-18T08:16:22","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/chi-controlla-chi-produce-i-principi-attivi\/"},"modified":"2026-09-21T12:21:19","modified_gmt":"2026-09-21T10:21:19","slug":"chi-controlla-chi-produce-i-principi-attivi","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/api-excipients\/chi-controlla-chi-produce-i-principi-attivi\/","title":{"rendered":"Who oversees active pharmaceutical ingredient manufacturers?"},"content":{"rendered":"

An active pharmaceutical ingredient<\/strong> is manufactured in India. It enters the supply chain of a European company, is used to manufacture medicinal products intended for different markets and ultimately falls, directly or indirectly, under the oversight of multiple regulatory authorities.<\/p>\n

Who is responsible for inspecting that manufacturing site? The most intuitive answer may also be the least sustainable one.<\/p>\n

Not because there are too many inspections. The real question is whether it makes sense for different authorities to deploy inspectors, time and resources to assess the same site separately, perhaps only a few months apart, when a substantial share of the information collected could be shared.<\/p>\n

This is precisely the issue addressed by the International Active Pharmaceutical Ingredient Inspection Programme<\/strong>, the international programme dedicated to inspections of active pharmaceutical ingredient manufacturers. Launched as a pilot project in 2008\u20132010 and established as an ongoing programme in 2011, it has progressively built a network of cooperation among regulatory authorities.<\/p>\n

A new report published by the European Medicines Agency on 14 September 2026<\/strong> provides a picture of developments between 2017 and 2024. Over this period, participation in the programme increased from 10 to 13 regulatory authorities, with Health Canada, Japan\u2019s PMDA and Brazil\u2019s ANVISA among those joining.<\/p>\n

Behind these figures, however, lies a question that is more interesting than administrative cooperation alone. It is the story of a regulatory system that is learning to trust the work of other authorities.<\/p>\n

Read the report<\/span><\/a><\/p>\n

Nine hundred and thirty-six sites and an overlap problem<\/h2>\n

Between 2017 and 2024, information was shared on 936 inspected sites<\/strong>. The overall volume of inspections increased by approximately 50% compared with the previous reporting period, while 69% of the sites identified were of common interest to more than one participating authority.<\/p>\n

That 69% says a great deal about the geography of today\u2019s pharmaceutical industry.<\/p>\n

A single active pharmaceutical ingredient manufacturer may supply chains extending across multiple markets. There may be only one manufacturing site, but many regulatory authorities may have an interest in knowing its compliance status.<\/p>\n

When each authority acts independently, the consequence is almost inevitable: some inspection activities will overlap.<\/p>\n

The issue becomes even more significant when we consider that inspection resources are finite. A GMP inspection requires specialist expertise, preparation, on-site presence or remote activities, document review, report writing and the management of any necessary follow-up. Deploying these resources repeatedly to inspect the same manufacturing site also means diverting them from other sites that may require attention.<\/p>\n

This is where the concept of reliance<\/strong> comes into play. During the period covered by the EMA report, 107 sites benefited from some form of inspection reliance: in other words, one authority was able to use inspection work carried out by another as part of its own oversight process.<\/p>\n

This is a more significant step than it might initially appear.<\/p>\n

Trust does not mean giving up oversight<\/h2>\n

The term reliance<\/em> can be misleading if it is interpreted as delegating oversight.<\/p>\n

The principle is different. A regulatory authority retains responsibility for its own decisions, but may use assessments and information produced by another authority when the conditions for doing so are met.<\/p>\n

The European Union already applies this approach through Mutual Recognition Agreements (MRAs)<\/strong> on GMP with third countries. These agreements allow the authorities involved to rely on each other\u2019s inspections, share information on inspections and quality defects and, where applicable, avoid certain duplicated activities.<\/p>\n

For active pharmaceutical ingredients, EMA also clarifies that where a Mutual Recognition Agreement covering GMP for active substances is in place, the outcome of an inspection conducted by the partner authority may be taken into account when deciding whether an EU inspection of the site is necessary.<\/p>\n

The distinction matters. Reliance does not eliminate oversight. It changes the question that comes before it.<\/p>\n

Is it always necessary to return physically to the manufacturing site, or is sufficiently recent, complete and reliable information already available to make a decision without duplicating work that has already been carried out?<\/p>\n

In a global supply chain, this is becoming an increasingly difficult question to avoid.<\/p>\n

The pandemic accelerated a shift that was already under way<\/h2>\n

The period covered by the report includes an obvious disruption: Covid-19.<\/p>\n

Travel restrictions drastically reduced the possibility of conducting on-site inspections and forced regulatory authorities to use alternative tools. The international API inspection programme recorded 91 remote inspections<\/strong>, while the inability to reach many manufacturing sites increased reliance on information sharing and inspection reliance.<\/p>\n

What began as a response to an immediate necessity left a lasting legacy.<\/p>\n

EMA continues to acknowledge that national competent authorities may complement routine on-site inspections with distant assessments<\/strong> and information from inspections conducted by international partners to build an overall picture of a site\u2019s compliance status.<\/p>\n

The pandemic, in other words, revealed something that would probably have emerged anyway: an inspection system still largely organised along national lines has to contend with a manufacturing landscape that ceased to be national a long time ago.<\/p>\n

The limits of cooperation<\/h2>\n

While the model appears rational, the data also show how difficult it can be to put into practice.<\/p>\n

Joint inspections declined and involved just 4.2% of sites of common interest<\/strong>. The report also points to persistent duplication, particularly when non-compliance findings emerge.<\/p>\n

And this is understandable. Sharing an inspection outcome is relatively straightforward when everything is compliant. It becomes more sensitive when that outcome may lead to regulatory decisions, restrictions, further inspections or consequences for the availability of an active pharmaceutical ingredient.<\/p>\n

There are also very practical obstacles: legal constraints, confidentiality requirements, language differences and difficulties in sharing inspection reports in a timely manner. Even the project to develop a centralised platform for information exchange has encountered technical and regulatory limitations.<\/p>\n

Technology, in this case, is probably the simplest part. The real challenge is determining what information can be shared, between whom, under what safeguards and, above all, what degree of equivalence can be established between different inspection systems.<\/p>\n

Because reliance only works when it is built on trust.<\/p>\n

And regulatory trust has to be built.<\/p>\n

Who inspects the inspectors?<\/h2>\n

Europe is very familiar with the issue.<\/p>\n

Within the European Economic Area, a Joint Audit Programme<\/strong> has been in place for years, under which GMP inspectorates are themselves subject to audit. Its stated objective is to verify the consistency of standards and maintain a harmonised approach across regulatory authorities. Joint visits also help build and maintain the mutual trust that makes it possible to accept the results produced by another inspectorate.<\/p>\n

This is perhaps the least visible, yet most important, part of the process.<\/p>\n

Sharing an inspection requires more than simply exchanging the report. There must also be confidence in the system that produced it: inspector qualification, procedures, criteria for classifying observations, management of non-compliance, quality of documentation and follow-up.<\/p>\n

International cooperation therefore shifts some of the focus from the individual manufacturing site to the quality of the inspection system itself.<\/p>\n

In other words, before trusting the inspection, regulators need to trust the inspectorate.<\/p>\n

A shared repository is more than just a database<\/h2>\n

Among the programme\u2019s future priorities is improving the timely exchange of information. The report also returns to the idea of a secure, centralised platform that could make the sharing of data and inspection reports more effective, while acknowledging the obstacles encountered so far.<\/p>\n

Europe already has EudraGMDP<\/strong>, the database managed by EMA that brings together information submitted by the competent authorities of the European Economic Area on manufacturing and wholesale distribution authorisations, GMP and GDP certificates, and statements of non-compliance.<\/p>\n

Extending this information-sharing model to an international scale, however, introduces another level of complexity.<\/p>\n

A shared infrastructure could allow regulatory authorities to quickly determine whether a site has already been inspected, by whom, when, with what outcome, and whether relevant information is available before scheduling a new inspection.<\/p>\n

It may sound like a matter of efficiency. In fact, it directly affects how inspection capacity is allocated.<\/p>\n

If redundant inspections of sites that have already been adequately assessed can be avoided, resources can be directed towards manufacturers that have never been inspected, sites with higher risk profiles, or situations where signals of potential non-compliance have emerged.<\/p>\n

Cooperation therefore also becomes a tool for risk-based inspection planning<\/strong>.<\/p>\n

Does a global supply chain require global oversight?<\/h2>\n

This is where the issue intersects with one of the major industrial questions of recent years.<\/p>\n

Europe is debating manufacturing dependencies, critical medicines, supply chain vulnerabilities and the need to strengthen its domestic manufacturing capacity. But bringing some production back to Europe will not erase the global nature of the pharmaceutical supply chain.<\/p>\n

Raw materials, intermediates, active pharmaceutical ingredients, excipients and components will continue to cross borders and move between different regulatory systems.<\/p>\n

The question, therefore, is not only where<\/strong> to manufacture. It is also how to oversee manufacturing that is distributed on a global scale<\/strong>.<\/p>\n

The EMA report provides an answer that is still incomplete, but it points in a clear direction: share information, coordinate inspections, rely on the work of other authorities where possible, and concentrate resources where the risk requires them most.<\/p>\n

Yet there is a tension that is difficult to eliminate: the more interdependent the supply chain becomes, the more regulatory oversight depends on cooperation. And the more the system relies on cooperation, the more confidence it must have in the authorities whose work it chooses to rely on.<\/p>\n

Perhaps this is where an important part of the future of GMP oversight will be decided: not by multiplying inspections, but by understanding which controls can be shared without reducing the ability to see what matters<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Un nuovo rapporto EMA fotografa l\u2019evoluzione della cooperazione internazionale nelle ispezioni GMP dei produttori di principi attivi. Tra reliance, controlli congiunti e condivisione dei dati, la vigilanza si confronta con una supply chain sempre pi\u00f9 globale e con una domanda decisiva: quando un\u2019autorit\u00e0 pu\u00f2 affidarsi all\u2019ispezione effettuata da un\u2019altra?<\/p>\n","protected":false},"author":32,"featured_media":27390,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[812],"tags":[],"class_list":{"0":"post-27401","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-api-excipients"},"yoast_head":"\nWho oversees active pharmaceutical ingredient manufacturers? - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"The new EMA report on GMP inspections of active pharmaceutical ingredient manufacturers shows how reliance and cooperation are reshaping global regulatory oversight.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/api-excipients\/chi-controlla-chi-produce-i-principi-attivi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Who oversees active pharmaceutical ingredient manufacturers? 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