IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18


Inside this issue


EU-US FDA mutual recognition of inspections expanded

1 March marked the beginning of mutual recognition of inspections of manufacturing sites for human medicines between the US and four new Member States of the European Union – Czech Republic, Greece, Hungary and Romania.

This follows on from the start of the operation phase of the mutual recognition agreement (MRA), which got underway on 1 November last year between the US and eight other EU countries (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK). Plans for the agreement to be operational in all EU member states by 15 July 2019 remain on track, according to the EMA.

According to the EMA the MRA “strengthens reliance upon each other’s inspection expertise and resources” and brings “mutual benefits” including:

  • The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
  • Prioritizing inspections of medicines manufacturing sites for higher risk cases; 
  • Reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
  • Improving the ability to identify and address problems at manufacturing sites before they become a public health risk; and
  • Reducing the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers.




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