On 1 September 2024, the Saudi Data and AI Authority (SDAIA) published the Regulation on Personal Data Transfer Outside the Kingdom (“Data Transfer Regulations”), which amended the previous Transfer Regulations under the Personal Data Protection Law issued by Royal Decree No. (M/19) dated 9/2/1443 AH and amended by Royal Decree No. (M/148) dated 5/9/1444 AH (“PDPL”). SDAIA also published additional information on Standard Contractual Clauses and Binding Common Rules, two of the appropriate safeguards for transferring data outside of the Kingdom, as well as a number of PDPL-related rules and guidelines. A summary of our initial takeaways can be found below.

The Heads of Medicine Agency has published a letter highlighting its plans to collaborate with other European medicines agencies to build knowledge on the approaches taken by member states with a record of effective, consistent trial reporting, with a view to sharing guidance with all member states as to “best practice” clinical trial reporting ahead of the new Clinical Trial Regulation and enhanced transparency rules coming into force. This article sets out the reasoning behind the letter’s publication, as well as an overview of key provisions within the CTR.

On 15 June 2021, after an initial consensus from health ministers in Luxembourg, the European Parliament’s health committee approved an extension of the European Medicines Agency’s (EMA) mandate.