EMA reports on international API inspection sharing effort
A recent report from the European Medicines Agency (EMA) highlights that global regulators are strongly committed to sharing plans for good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) suppliers yet have made only moderate progress toward sharing inspection reports in recent years. Joint inspections remain a challenging area, evidenced by a 50% decrease compared to the previous reporting period.
The findings were published in a report by the European Medicines Agency (EMA), which summarizes the progress of the International Active Pharmaceutical Ingredient Inspection program from 2017 to 2024. The report also compares these findings to an earlier report that tracked the program's progress from 2011 to 2016.
The program, which began as a pilot in 2008 and expanded to a full initiative in January 2011, involves regulators sharing information on GMP inspections of API suppliers. Additionally, it allows for joint inspections of facilities located outside of participating countries. The main objective of this program is to reduce duplicate inspections and optimize the use of inspection resources.
The need for this program arose from the globalization of API manufacturing and the increased need for international inspections to ensure adequate oversight, to combat limited regulatory resources and to harmonize regulatory standards, according to Phillip Arntz, of EMA inspections office who discussed these activities at a conference in Budapest in September 2025.
This program was expanded from ten regulators since its inception to 13 authorities, and includes regulators from Australia, France, Italy, Ireland, the United Kingdom, Denmark, Germany, the EU’s European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the World Health Organization (WHO), Canada, Japan and Brazil.
EMA said it distributed a questionnaire to participating regulators between March and May 2024 to assess their commitment to meeting the program's goals.
Most participating authorities demonstrated a positive commitment to the program, contingent on their internal resources and legal provisions. The strongest commitment was observed in the sharing of planned inspections and outcomes. However, the practical implementation of other goals, such as sharing inspection reports “indicated moderate progress with room for improvement.” Joint inspections remain the most challenging area, evidenced by a 50% decrease compared to the previous period.
Between 2017 and 2024, a total of 1,684 API inspections were conducted by these authorities at 936 sites. FDA and Japan’s PMDA conducted the most inspections, with 686 FDA inspections followed by 292 PMDA inspections; European authorities participating conducted 275 of the inspections. The European inspections included contributions from Denmark, France, Ireland, Italy, the United Kingdom, and EMA.
The report identifies 644 sites of “shared interest” out of 936 sites across 18 countries. The vast majority of the sites were located in India (50%) and China (35%), with sites in 16 countries representing the remainder.
Regulators reported that they relied on other’s inspections at 107 sites out of 644, or 17% of the total. Such reliance included reviewing GMP certificates and reviewing inspection reports from other authorities. However, this figure may be an underestimate “due to inconsistent tracking and varied practices, especially during COVID.”
Challenges faced in sharing these reports included the language in which they were written, the need to obtain permission from the manufacturer prior to sharing, and the requirement to redact specific sections to comply with local legal regulations.
The report notes that “joint inspections remain the most challenging area, which is confirmed by the 50% decrease compared to the previous period.”
The report states that a total of 27 joint inspections were conducted at 25 sites, which represents 4.2% of the 644 sites of shared interest. In contrast, during the previous six-year period, 47 joint inspections were carried out at 43 sites, accounting for 10% of 458 sites of shared interest. The report attributes the decline in joint inspections to "operational and resource constraints."
The report notes that “the decline in joint inspections potentially reflects the growing efficiency of information-sharing and reliance practices. This optimizes resources but also strengthens strategic collaboration by reducing redundant efforts.”
