Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US And EU Look To Expand Inspection Agreement

Executive Summary

Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.

You may also be interested in...



Monkeypox: Bavarian Nordic’s Jynneos Vaccine Should Be Given Only As A Two-Dose Series, US FDA Says

Despite limited vaccine supplies and a growing number of cases, public health officials nix the idea of giving only one dose of Jynneos to individuals exposed or at high risk, saying that two doses one month apart are required for full protection; FDA says it is working to expedite the availability by late July of an additional 786,000 doses made in Denmark.

European Enforcement Activity Picks Up After Medicines Agency's Relocation

With the European Medicines Agency's Amsterdam move completed and the US/EU inspections MRA guillotine stayed, lull in EU drug GMP noncompliance notices has ended.

US-EU Inspection Deal Hits Milestone As Batch Test Waiver Kicks In

After 20 years in the making, the landmark GMP inspection MRA between the US and the EU is finally fully implemented. In addition, a batch test waiver has started to apply under the deal.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125635

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel