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

Pharma wins reduction in data requirements for EU EVMPD product database

This article was originally published in SRA

Executive Summary

Following strong lobbying by the pharmaceutical industry, the European Medicines Agency has substantially reduced the amount of information that companies must provide by 2 July on all the products they market in the EU1,2. Industry will be relieved at the move, having pushed hard for a delay to the deadline or at least a reduction in the scope of the requirement.

You may also be interested in...



EU & US At Odds Over Merck’s Keytruda

EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.

First African Approvals For Merck’s Ebola Vaccine

Regulators have pulled out all the stops in their efforts to get the Ebola vaccine to the marketing authorization stage in Africa. 

UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System

At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling.

UsernamePublicRestriction

Register

PS116673

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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