Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


FDA is “redoubling” harmonization efforts

This article was originally published in The Gold Sheet

Executive Summary

FDA is working on an exchange of letters with Japan; developing a Memorandum of Understanding with Switzerland; working on a MOU with Australia; and developing an exchange of letters as well as a mutual recognition agreement with the EU, reported Friedman at the June 23 Pharma Conference. In addition, FDA is working on a MOU with Canada, and developing a trilateral cooperation agreement with Canada and Mexico. As a result of these agreements with the EU in particular, Friedman reported that "we could potentially be doing less inspections in the EU in the next couple of years … and more inspections in the emerging economies of China and India." He added that "we are interested in harmonization. We are seeking membership in PIC/S for the reason that PIC/S has more members and more harmonized techniques than ICH

You may also be interested in...

Bayer Confident CureVac COVID Pact Will Be A Success

CEO Werner Baumann admits he was skeptical at first as to whether the German group had the necessary know-how to manufacture vaccines but the firm's expertise in the development of biotech products has strengthened his belief Bayer can deliver.

EMA Works On Defining Metadata From RWD Sources

As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.

UCB And Microsoft Expand AI Tie-Up Beyond COVID-19

Two European pharmaceutical companies, UCB and Merck KGaA, are exploring artificial intelligence in different ways, the first for drug discovery and the second on a fundamental level.




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