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As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.
Nations that are part of this agreement will avoid duplication of inspections to ensure drug safety, the FDA reports. In addition, these nations can concentrate their resources on inspections of drug manufacturing facilities around the globe with higher public health risks.
The agreement allows the FDA to recognize inspections carried out by other nations whose regulatory systems meet U.S. requirements, according to the FDA.
Such inspections can help to determine a drug’s suitability for introduction into the U.S. market, the FDA said.
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Nations in Mutual Recognition Agreement for Drug Inspections
| Country | Regulatory Authority for Medicinal Products | Recognition Date |
| Germany | ZLG | June 26, 2019 |
| Luxembourg | Ministere de la Sante | June 10, 2019 |
| Netherlands | Healthcare Inspectorate | June 10, 2019 |
| Bulgaria | Bulgarian Drug Agency | April 29, 2019 |
| Cyprus | Ministry of Health - Pharmaceutical Inspectorate | April 29, 2019 |
| Poland | Main Pharmaceutical Inspectorate | Feb. 7, 2019 |
| Slovenia | Agency for Medicinal Products and Medical Devices | Feb. 7, 2019 |
| Estonia | State Agency of Medicines | Nov. 28, 2018 |
| Belgium | Federal Agency for Medical and Health Products | Nov. 16, 2018 |
| Denmark | Danish Medicines Agency | Nov. 16, 2018 |
| Finland | Finnish Medicines Agency | Nov. 16, 2018 |
| Latvia | State Agency of Medicines | Nov. 16, 2018 |
| Portugal | National Authority of Medicines and Health Products | Sept. 14, 2018 |
| Ireland | Health Products Regulatory Authority | June 1, 2018 |
| Lithuania | State Medicines Control Agency | June 1, 2018 |
| Greece | National Organisation for Medicines | March 1, 2018 |
| Hungary | National Institute of Pharmacy and Nutrition | March 1, 2018 |
| Czech Republic | State Institute for Drug Control | March 1, 2018 |
| Romania | National Agency for Medicines and Medical Devices | March 1, 2018 |
| United States | Food and Drug Administration | Nov. 1, 2017 |
| Austria | Austrian Agency for Health and Food Safety | Nov. 1, 2017 |
| Croatia | Agency for Medicinal Products and Medical Devices | Nov. 1, 2017 |
| France | French National Agency for Medicines and Health Products Safety | Nov. 1, 2017 |
| Italy | Italian Medicines Agency | Nov. 1, 2017 |
| Malta | Medicines Regulatory Authority | Nov. 1, 2017 |
| Spain | Spanish Agency of Medicines and Medical Devices | Nov. 1, 2017 |
| Sweden | Medical Products Agency | Nov. 1, 2017 |
| United Kingdom | Medicines and Healthcare Products Regulatory Agency | Nov. 1, 2017 |
