Regulatory Blog

Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...

The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...

Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...

The Saudi Food and Drug Authority (SFDA) released an updated guidance (7th February, 2023) on "National Diagnostic Reference Levels"....

Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...

Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...

The Saudi Food and Drug Authority recently released (13- November-2022) updated guidance on "Conditional Approval for Medicinal Products...

Earlier today (27-October-2022) the Saudi Food & Drug Authority (SFDA) released updated guidance on "Good Regulatory Practice". A Good...

On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...

On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...

This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...

On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...

On 27 March,2022 the Saudi Food and Drug Authority (SFDA) released this guidance detailing the Requirements for the Import and Clearance...

Medical devices that are innovative play an important role in improving and facilitating the quality of life of both patients and...

SFDA updated their Biowaiver guideline recently. These guidelines are intended to facilitate and support the workflow of drug...

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the...

Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early...

Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished...

Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...