Drugs

Guidelines for Bioequivalence

2024-05-21
Guidelines for Bioequivalence
Guide
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Baseline eCTDSubmission Requirement

2016-06-26
Baseline eCTDSubmission Requirement
Guide
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Guidance for the Preparation of a Site Master File (SMF)

2022-11-09
Guidance for the Preparation of a Site Master File (SMF)
Guide
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National Manual for Surveillance of Adverse Events Following Immunization in Saudi Arabia

2024-11-10
National Manual for Surveillance of Adverse Events Following Immunization in Saudi Arabia
Guide
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Regulation and Requirements for Conducting Clinical Trials on Drug

2025-02-02
Regulation and Requirements for Conducting Clinical Trials on Drug
Guide
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Guideline on Biosimilar Products (Quality Considerations)

2017-08-22
Guideline on Biosimilar Products (Quality Considerations)
Guide
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Guideline on Blood Products (Plasma Derived Medicinal Products)

2022-11-09
Guideline on Blood Products (Plasma Derived Medicinal Products)
Guide
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Guideline on the Scientific Data Requirements for Plasma Master File (PMF)

2023-12-11
Guideline on the Scientific Data Requirements for Plasma Master File (PMF)
Guide
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The Data Requirements for Human Drugs Submission

2022-10-13
The Data Requirements for Human Drugs Submission
Guide
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Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products

2022-08-22
Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
Guide
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