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

UsernamePublicRestriction
UsernamePublicRestriction

EU Member States, Industry Not Ready Yet For New Clinical Trials Regime

This article was originally published in The Pink Sheet Daily

Executive Summary

With less than two years to go before implementation of the new EU Clinical Trials Regulation, there is a divergence of approaches amongst member states and some ignorance amongst trial sponsors.

You may also be interested in...



MEPs Pass Clinical Trials Laws But Implementation Will Be Troublesome

Europe’s parliamentarians have unsurprisingly and overwhelmingly voted in favor of the Clinical Trials Regulation – but implementation and transparency problems hover on the horizon.

MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins

In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.

EMA Acts To Freeze GVK Drugs, Guard Against Shortages

The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1135489

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