SFDA’s New Contract Research Organization Draft Guideline

Saudi Arabia has positioned itself as a hub for healthcare and pharmaceutical companies in the GCC region and in recent years, has been providing further regulatory coverage for companies seeking to conduct clinical trials in Saudi Arabia. The Saudi Food and Drug General Authority (“SFDA”) has published guidelines on conducting clinical trials in Saudi Arabia – these include the Guideline for Good Clinical Practice, Regulations and Requirements for Conducting Clinical Trials on Drugs, and Guidance for Investors on Licensing Contract Research Organizations (“CROs”). The SFDA has recently proposed a new draft guideline, which aims to regulate, support, improve and extend the collaboration between licensed CROs, clinical trials sponsors, and regulators (collectively referred to as “Parties”). The guideline aims to minimize gaps between licensed CROs clinical trial sponsors and regulators.

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