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.
“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.”
“If you get an approval in Europe, there are testings that you have to do for EU.”
“Effective 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.”
“So, 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, they will be fully separated from the European Union.”
“The mutual recognition that is between the FDA and EU, I see that as becoming more and more the norm.”
“Once you get the approval [in the EU], you get it in all twenty-seven countries, including Norway, Iceland and I think Lithuania.”
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