EMA Reports inconsistent Progress in International API Inspection Cooperation

Regulators Strengthen Cooperation

A recent European Medicines Agency (EMA) review shows that international regulators continue to support closer cooperation in the oversight of active pharmaceutical ingredient (API) manufacturers. The assessment covers the period from 2017 to 2024 and follows an earlier review of the program’s development between 2011 and 2016.

The International API Inspection Program began as a pilot in 2008 before becoming a permanent initiative in 2011. Its objective is to reduce repeated inspections, improve the exchange of regulatory information and use inspection resources more efficiently.The initiative now brings together 13 regulatory authorities from countries and organizations including Australia, Brazil, Canada, Japan, the United Kingdom, the United States, the European Union and the World Health Organization.

Inspection Activity Focused on India and China

Between 2017 and 2024, the participating authorities conducted 1,684 inspections at 936 API manufacturing sites. The main contributors were the US Food and Drug Administration and Japan’s PMDA. European authorities collectively carried out 275 inspections.

The review identified 644 facilities as being of common interest to more than one regulator. Their geographical distribution was heavily concentrated in Asia:

• 50% of the sites were located in India.
• 35% were located in China.
• The remaining sites were spread across 16 other countries.

Regulators stated that they had used inspection information from other authorities at 107 of these sites. This corresponds to 17% of the facilities considered to be of shared interest. EMA noted that the actual level of reliance may be higher, as authorities did not always document these activities consistently, particularly during the COVID-19 pandemic.

Inspection Reports Still Difficult to Exchange

The strongest level of support was reported for sharing information about planned inspections and their results. However, the exchange of detailed inspection reports has developed more slowly.

The review highlights several obstacles:

• Reports may be prepared in different languages.
• Some authorities require the manufacturer’s approval before information can be shared.
• Confidential or legally protected material may have to be removed.
• National legal requirements can limit the type of information that regulators are permitted to exchange.

These challenges mean that, although the participating authorities generally support the program’s objectives, implementation still varies in practice.

Joint Inspections Remain Limited

Joint inspections continue to be the most difficult aspect of the initiative. Between 2017 and 2024, regulators carried out 27 joint inspections at 25 sites. In the previous reporting period, there had been 47 joint inspections at 43 sites.

The latest figures represent:

• 4.2% of the 644 sites of shared interest.
• A decrease from 10% in the previous assessment.
• A decline that EMA primarily associates with operational and resource constraints.

Reliance Could Reduce Duplication

EMA also pointed out that the reduction in joint inspections does not necessarily indicate weaker cooperation. Greater reliance on inspection results and more efficient information-sharing arrangements may allow authorities to avoid repeating work already performed by another regulator.Overall, the report confirms continued international support for coordinated API oversight. At the same time, it underlines the need to improve the practical exchange of inspection reports, harmonize documentation practices and address the resource and organizational barriers affecting joint inspections.

The complete report can be found on the EMA website.