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


CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State

Executive Summary

The coordination group of EU member state regulators was recently presented with an exceptional case where all concerned member states initially refused to become the new reference member state for a drug evaluated by the UK. The group explained that 'unscheduled switches' can result in unforeseen workload, resulting in member states refusing to take on the RMS role.

You may also be interested in...

EMA Redistributes Responsibility For 370 Drugs Currently Overseen By UK

The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.

EU Regulators Address Challenges In Switching Reference Member State

EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the switch in cases where all the strengths of the drug are not approved in any concerned member state.

Norway COVID-19 Vaccine Deaths Draw Global Attention

Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.





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