EMA and FDA to recognize GMP inspections

Home/Policies & Legislation | Posted 24/03/2017 post-comment0 Post your comment

European Union (EU) and US regulators have agreed to recognize inspections of drugmakers in Europe and the US.

Shaking hands V13D29

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced on 2 March 2017 that they had agreed to recognize good manufacturing practice (GMP) inspections of pharmaceutical manufacturing sites conducted in their respective territories on both sides of the Atlantic.

The Mutual Recognition Agreement, which ‎represents the culmination of nearly three years of cooperation between the two regulatory agencies as part of the Mutual Reliance Initiative, will come into force in November 2017. The agreement will enable both the EMA and FDA to make better use of their inspection resources by enabling the agencies to avoid the duplication of drug inspections, lower inspection costs and enabling them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured.

EMA estimates that around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the EU.

The idea of collaboration to lighten the load is not new for EMA and FDA. The agencies launched a three-year pilot programme in April 2011 to allow parallel evaluation of quality elements, known as Quality by Design, of selected applications submitted to both agencies at the same time [1]. In addition, EMA has existing Mutual Recognition Agreements for GMP inspections in place for several other countries including Australia, New Zealand, Canada, Japan and Switzerland.

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1. GaBI Online - Generics and Biosimilars Initiative. EMA, FDA and TGA joint GMP inspection programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 24]. Available from: www.gabionline.net/Guidelines/EMA-FDA-and-TGA-joint-GMP-inspection-programme

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Source: EMA, US FDA

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