Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 31 October 2017 | By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements.
The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug manufacturing inspections worldwide.
“At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck," FDA Commissioner Scott Gottlieb said in a statement.
Last month, the European Commission also said that FDA can carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. The European Medicines Agency also has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.
In addition to avoiding duplicate inspections, the completion of these capability assessments enables the FDA and the EU to devote more resources to higher-risk manufacturing facilities.
Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy, added: "The progress made so far puts us on track to meet our goal of completing all 28 capability assessments in the EU by July 2019."
Tags: FDA and EMA mutual recognition, GMP inspections, MRA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.