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

Global Pharma Guidance Tracker – April 2021

Executive Summary

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

You may also be interested in...



BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

COVID-19 Vaccines: Regulatory Consortium Addresses Way Forward With Immunobridging Studies

Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials. 

One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

Topics

UsernamePublicRestriction

Register

PS144381

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