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

Saudi Arabia Slashes Time To Market With Abridged Applications

Executive Summary

A new abridged drug review system in Saudi Arabia will dramatically cut the time it takes to get a new product to market in Saudi Arabia. The new system, which will go live in February 2017, could have a knock on effect on market access in neighboring markets.

You may also be interested in...



Revised Saudi Guide Addresses Frequent Questions On New Expedited Drug Registration Process

The Saudi FDA has issued four revised guidelines, including one on its recently-launched expedited process for registering new drugs and biologics based on the product’s prior approval in the US and the EU.

Saudi Arabia's Pharma Market Is 'Open For Business'

Growing market is also a gateway to the Gulf region, and Saudi regulators are developing an abridged review process for some drugs already reviewed by agencies such as FDA or EMA.

Future Unclear For EU Mandatory Joint Clinical Assessment Plans

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

Topics

Related Companies

UsernamePublicRestriction

Register

PS119436

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