Saudi Arabia Slashes Time To Market With Abridged Applications
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.
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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.
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.
Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.