Scrip 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

No need for independent ethics committees, says UK MHRA

This article was originally published in RAJ Devices

Executive Summary

The UK Medicines and Healthcare products Regulatory Agency has updated two guidance documents from its series on the European Union medical device directives to clarify the fact that the agency does not accept approvals of clinical investigations from independent ethics committees1-3.

You may also be interested in...



Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes

Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.

EMA Prepares Approval Verdict On Beovu, Idhifa, Recarbrio

Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.

Orchard’s Gene Therapy Under Fast-Track Review At EMA

A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.
UsernamePublicRestriction

Register

SC095405

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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