Brexit: What You Need to Know for Drug Development

Brexit: What You Need to Know for Drug Development

CMC016 Amber Sheriff Square v2

Episode Summary

Amber Sheriff is a Senior Regulatory Affairs Consultant at Design Space InPharmatics. With more than 32 years of experience, Amber is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, and briefing books, to name a few. In this episode, Amber, Ed, Meranda and Brian discuss regulatory pathways in the European Union (EU), the impact Brexit has had on CMC filings, and the advantages and disadvantages of the three defined procedures to obtain approval for products in Europe.

What We Covered

  • 00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs specialist in the pharmaceutical industry and the three procedures for obtaining market authorization in the European Union
  • 06:15 – What CMC drug development looks like in the EU and how it differs from the United States
  • 11:24 – Amber breaks down specifics of the centralized filing procedure in the EU
  • 15:49 – Amber provides insights on the impact of Brexit on CMC filing in the EU
  • 18:40 – Benefits and advantages of a decentralized or mutual recognition procedure
  • 23:28 – Amber speculates on the future of drug regulation, including collaborations between the FDA and the EU
  • 27:57 – Finals thoughts from Amber
  • 31:28 – Ed, Brian and Meranda thank Amber for joining the show

Tweetable Quotes

In principle, there are three procedures for obtaining market authorization in EU. One is the mutual recognition procedure. The second one is the decentralized. And then the third one is the centralized procedure. Click To TweetIf you get an approval in Europe, there are testings that you have to do for EU. Click To TweetEffective planning is the key. Because then basically you know when you’re going to get approval and you’ll know when you will be able to market. Click To TweetSo, what is happening now, people who have filed in the UK can no longer sell their products in EU because UK walked away from the European Union. So now they are setting up their own procedures because, by the end of this year,… Click To TweetThe mutual recognition that is between the FDA and EU, I see that as becoming more and more the norm. Click To TweetOnce you get the approval (in the EU), you get it in all twenty-seven countries, including Norway, Iceland and I think Lithuania. Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Amber Sheriff on LinkedIn