FDA-EMA mutual recognition: Germany in, one country left

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Cunaplus_M.Faba)
(Image: Getty/Cunaplus_M.Faba)

Related tags: European medicines agency, Ema, Fda, Food and drug administration, Mutual recognition, Inspection

With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.

The US Food and Drug Administrator (FDA) confirmed the capability of Germany’s regulatory authority for medicinal products, Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), to carry out good manufacturing practice (GMP) inspections of drug manufacturers.

The mutual recognition agreement between the FDA and the European Medicines Agency (EMA), which was initially announced in 2017, allows the partners to recognize the inspections carried out by each other.

Through this project, the partners aim to reduce the regulatory burden by avoiding duplicate inspections.

On 1 November 2017, the FDA confirmed the capability of the first of eight EU member states: Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.

Since then, the FDA has continued inspections​ and has now confirmed the capability of 27 of the 28 countries, with only Slovakia still to be confirmed.

According to previous confirmations​ from the EMA, the arrangement is ‘on track’ for the deadline of July 15, 2019.

The EU has made similar arrangements with Australia, Canada, Israel, Japan, New Zealand, and Switzerland, in addition to the US.

The agreement with Japan was signed in 2004 and extended in 2018​ to include certain biological medicines, including immunologicals and vaccines, which will no longer need to be inspected once they have been delivered to the other’s territory.

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