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U.S. FDA will acknowledge the results of Estonian Medicine Agency inspections

The US Food and Drug Administration (U.S. FDA) has, after thorough evaluation, concluded that the Estonian State Agency of Medicines has procedures and sufficient capacity to perform GMP inspections at manufacturers of medicinal products for human use at a level that meets the requirements of the US Food and Drug Administration. This means that if the Inspector of the State Agency of Medicines has carried out an inspection at an Estonian company, the US Inspectorate will rely on them and may not carry out additional activities. Ultimately, it will make it easier for Estonian based companies to enter the US market.

This is an important acknowledgment for Estonia, which proves that even with limited resources, through good training and procedures, it is possible to achieve a high-quality and reliable result. At the time of the inspection, not all EU State Agencies had reached  similar level.



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