Thursday, September 19, 2019

Thursday, September 19, 2019

U.S., 27 EU nations join drug inspection accord

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.


Nations in Mutual Recognition Agreement for Drug Inspections

CountryRegulatory Authority for Medicinal ProductsRecognition Date
GermanyZLGJune 26, 2019
LuxembourgMinistere de la SanteJune 10, 2019
NetherlandsHealthcare InspectorateJune 10, 2019
BulgariaBulgarian Drug AgencyApril 29, 2019
CyprusMinistry of Health - Pharmaceutical InspectorateApril 29, 2019
PolandMain Pharmaceutical InspectorateFeb. 7, 2019
SloveniaAgency for Medicinal Products and Medical DevicesFeb. 7, 2019
EstoniaState Agency of MedicinesNov. 28, 2018
BelgiumFederal Agency for Medical and Health ProductsNov. 16, 2018
DenmarkDanish Medicines AgencyNov. 16, 2018
FinlandFinnish Medicines AgencyNov. 16, 2018
LatviaState Agency of MedicinesNov. 16, 2018
PortugalNational Authority of Medicines and Health ProductsSept. 14, 2018
IrelandHealth Products Regulatory AuthorityJune 1, 2018
LithuaniaState Medicines Control AgencyJune 1, 2018
GreeceNational Organisation for MedicinesMarch 1, 2018
HungaryNational Institute of Pharmacy and NutritionMarch 1, 2018
Czech RepublicState Institute for Drug ControlMarch 1, 2018
RomaniaNational Agency for Medicines and Medical DevicesMarch 1, 2018
United StatesFood and Drug AdministrationNov. 1, 2017
AustriaAustrian Agency for Health and Food SafetyNov. 1, 2017
CroatiaAgency for Medicinal Products and Medical DevicesNov. 1, 2017
FranceFrench National Agency for Medicines and Health Products SafetyNov. 1, 2017
ItalyItalian Medicines AgencyNov. 1, 2017
MaltaMedicines Regulatory AuthorityNov. 1, 2017
SpainSpanish Agency of Medicines and Medical Devices

Nov. 1, 2017
SwedenMedical Products AgencyNov. 1, 2017
United KingdomMedicines and Healthcare Products Regulatory AgencyNov. 1, 2017
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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