The Food and Drug Administration (FDA) has recognized the ability of 16 EU member states to conduct Good Manufacturing Practice inspections for certain veterinary products at a level equivalent to that of the US. Also, the EU has recognized the FDA. As the equivalent authority for GMP inspection of veterinary drug manufacturing sites.
This mutual recognition of the inspection of manufacturing facilities for certain veterinary products is an extension of the scope of the Mutual Recognition Agreement (MRA) between the EU and the US on 11 May.
The member states that have GMP inspections for veterinary drugs recognized by the FDA are Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, the Netherlands, Poland, Portugal, Slovenia, and Spain .
European Commission (EC), EU National Competent Authority (NCA) teams EMA EMA says, “The FDA continues to work closely to ensure the timely assessment of the 11 remaining competent authorities of the Member States, now that the difficulties caused by the COVID-19 pandemic have largely been eliminated Is.”
The MRA allows regulatory authorities to rely on the results of inspections of veterinary product manufacturing sites conducted in the respective territories of the Parties. The aim is to strengthen trust in inspection expertise and resources between EU and US regulators. From now on, the FDA must rely on inspections carried out by these 16 member states for veterinary products and by the EU member states and the EMA. Inspections done by FDA.
As the EMA states, the benefits of mutual recognition include the ability to focus inspection resources in other parts of the world where active pharmaceutical ingredients and medicines are manufactured; Prioritize inspection in high-risk cases; assure users that they can be confident in the quality, safety and efficacy of all medicines, regardless of where they are manufactured; Improve the ability of regulators to identify and address potential problems at manufacturing sites before they become a public health risk, and reduce the administrative burden and cost of duplicate inspections.
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