In this article, we will talk about the SFDA requirements for PSUR report submission, content, format, and more. Starting with an introduction and definitions of
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The SFDA has just announced a new update in the registration process of medical devices . It states that the full technical file assessment TFA
NDLP: Saudi Pharmaceutical Market is expected at $11.7 billion by 2030 (Views on Medical Devices Included)
The Saudi National Industrial Development and Logistics Program (NDLP) predicts that the size of the pharmaceutical market in the Kingdom will reach 44 billion Riyals
Details about the SFDA pharmacovigilance in Saudi Arabia and its requirements. When and how to hire a QPPV or contract with a pharmacovigilance Consultancy as per the SFDA pharmacovigilance guidelines GVP.
How EMA and FDA approvals help in getting SFDA approval in an accelerated assessment procedure. Learn more about what is called Abridged and verification registration.
During the SFDA registration of pharmaceutical products in Saudi Arabia, the manufacturers will undergo an SFDA GMP inspection. The sites that pass and able to
An overview on the regulatory strategy development process for the Saudi market. The analysis methods, elements to consider, documentation, and the series of recommended stages.
Learn about SFDA cosmetics registration and related regulations in Saudi Arabia. The eCosma application approval into the SFDA cosmetics list.
What is the SFDA authorized representative AR and its responsibilities in Saudi Arabia. Learn about the AR agreement template and the process of changing the authorized representative.