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Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval

The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive document outlines the procedures and requirements for obtaining approval for pharmaceuticals in Saudi Arabia. The framework is designed to ensure the safety, efficacy, and quality of drugs available in the Saudi market.


Regulatory Framework: A structured set of regulations and guidelines established by regulatory authorities to govern the approval and monitoring of pharmaceuticals.


This framework applies to all types of drug product submitted for registration, variation or renewal.


To provide stakeholders with assistance on how to submit applications for various types of drugs and the procedure for approving those applications, the Saudi Food and Drug Authority (SFDA) developed this administrative guidance. The MAA application describes not only market authorization applications (MAA) for various types of drugs, but also variations and renewal applications.Time-frame for processing applications to marketing the product in Saudi Arabia are also included in this guidance.


All marketing authorization applications must be submitted online through the SFDA's electronic portal. The SFDA conducts a detailed evaluation and upon successful completion of the evaluation and testing phases, the SFDA grants a product license, authorizing the marketing and distribution of the drug in Saudi Arabia.


The pricing of renewed authorizations is reviewed to ensure it remains appropriate and justified based on current market conditions and regulatory requirements. An applicant shall submit a renewal request every five years. It is possible to request for renewal within six months of the certificate expiry.


By adhering to this framework, pharmaceutical companies can ensure their products meet the stringent safety, efficacy, and quality standards required for approval in Saudi Arabia. For further details, please refer to the full regulatory framework document here.

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