The analytical group of the PHARMPROM portal conducted its own study of activity regarding the issuance of conclusions on compliance with Good Manufacturing Practice (GMP) rules. The analysis covers the period from March 23, 2021, to January 22, 2026, and is based on open data from the Ministry of Industry and Trade, consolidated in the Unified Register of Drug Manufacturers.
The sample included the TOP-10 manufacturing countries ranked by the total number of regulatory decisions (issuance of a certificate or refusal). These countries account for 2,599 out of 3,084 total decisions, which constitutes 84.3% of the regulator’s total inspection activity for the specified period.
Inspection Structure: Share of Russia and Foreign Sites
Since the object of the study is the Russian market, the Russian Federation takes first place in the number of inspections. Russian sites account for 1,641 decisions, which is 63% of the activity within the TOP-10.
Foreign manufacturers collectively occupy the remaining 37% in the top ten. This ratio reflects the high concentration of regulatory attention on localization and quality control within the country, while maintaining a significant volume of inspections of foreign suppliers.
Risk Zones: Correlation Between Volumes and Refusals
The study revealed a direct correlation: countries with the highest number of submitted applications also demonstrate the highest refusal rates.
- India: Ranks first in the share of negative decisions. Out of 188 inspections, 19.7% (37 cases) resulted in a refusal to issue a certificate.
- Russia: With a massive flow of applications (over 1.6 thousand), the refusal rate is 19.3%.
Such close figures (a difference of only 0.4%) for the two largest applicants indicate that almost every fifth inspection at key market sites reveals non-compliance with GMP requirements.
Efficiency of European Manufacturers, USA, and China
In contrast to the leaders in application volume, a number of European countries demonstrate high effectiveness in passing Russian inspections. Minimal refusal rates were recorded for Spain (5.6%), Ireland (6.8%), and Italy (6.9%). This indicates thorough preparation of manufacturing sites in these countries for the Russian regulator’s requirements.
Traditional pharmaceutical markets — Germany, the UK, and the USA — show a stable average result with a refusal rate in the range of 9–10%.
China’s Indicators
The People’s Republic of China ranks 8th in activity in the register (45 decisions). The refusal rate for Chinese sites is 11.1%. This is higher than Germany (10.0%) or the USA (9.2%), but significantly lower than India’s indicators, suggesting a stricter approach to compliance among the Chinese exporters represented in the sample.
Detailed Statistics for TOP-10 Countries (2021–2026)
Below are the summary data from the PHARMPROM study:
| Manufacturer Country | Issued (pcs.) | Refused (pcs.) | Total Decisions | Refusal Rate |
|---|---|---|---|---|
| Russia | 1324 | 317 | 1641 | 19.3% |
| Germany | 189 | 21 | 210 | 10.0% |
| India | 151 | 37 | 188 | 19.7% |
| Italy | 122 | 9 | 131 | 6.9% |
| France | 109 | 15 | 124 | 12.1% |
| USA | 109 | 11 | 120 | 9.2% |
| Spain | 51 | 3 | 54 | 5.6% |
| China | 40 | 5 | 45 | 11.1% |
| Ireland | 41 | 3 | 44 | 6.8% |
| United Kingdom | 38 | 4 | 42 | 9.5% |
| TOTAL (TOP-10) | 2134 | 425 | 2599 | 16.3% |
Imbalance of Quality Indicators
The results of the analysis for the five-year period record a significant gap in the quality of preparation for inspections. The difference between the refusal rate for India (19.7%) and Spain (5.6%) highlights the heterogeneity of compliance with global standards. Russia, providing the main market volume, bears risks of application rejection comparable to India.
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