The decision of the EU and the USA on the mutual recognition of inspections of pharmaceutical manufacturers can make it easier to enter these markets local Ukrainian pharmaceutical factories, according to the pharmaceutical company “Sanofi”.

“This decision will simplify access to the EU market or the US of drugs produced local Ukrainian factories. Legislative requirements to the production conditions in the EU and USA are about the same, but between them there are minor differences. Earlier, the Ukrainian pharmaceutical manufacturers have implemented EU legislation. If you have previously to enter the U.S. market, drug drug had to be inspected by the FDA (Food and Drug Administration), now it will be enough inspections of the EU, which is recognized in the United States (or Vice versa, the results of the FDA inspection of the Ukrainian drug will be able to enter the EU market). A significant difference was only that the FDA acted one year, and the EU – three years”, – said the Agency “Interfax-Ukraine” in the company of the decision.

In “Sanofi” also note that “medicines supplied to Ukraine from the EU and the USA do not differ in quality, and the factories where they are produced, inspected according to the same procedures for compliance with the same standards.”

While the company believes that this decision will affect the imports to Ukraine because of Ukraine and state agencies had previously recognized the results of the inspections and the US and the EU.

“As for the results of the Ukrainian inspections, they are not recognized neither in the US nor in the EU”, – noted in “Sanofi”.

As reported, the European Union and the United States agreed on mutual recognition of inspections of manufacturing facilities. Work on the implementation of the Agreement on mutual recognition will continue to expand operational coverage of veterinary drugs, human vaccines and medicinal products derived from plasma.

The mutual recognition agreement signed between the EU and the United States in 1998. It includes an Annex on pharmaceuticals, providing a perspective of constraint checks manufacturing practices (GMP) to each other.

Together, Europe and the United States account for more than 80% of global sales of new medicines.




#pharmaceutical market