Drugs

Guidance for the Preparation of a Site Master File (SMF)

2022-11-09
Guidance for the Preparation of a Site Master File (SMF)
Guide
Has the page content helped you?

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
Has the page content helped you?

Regulation and Requirements for Conducting Clinical Trials on Drug

2025-02-02
Regulation and Requirements for Conducting Clinical Trials on Drug
Guide
Has the page content helped you?

Guideline on Biosimilar Products (Quality Considerations)

2017-08-22
Guideline on Biosimilar Products (Quality Considerations)
Guide
Has the page content helped you?

Guideline on Blood Products (Plasma Derived Medicinal Products)

2022-11-09
Guideline on Blood Products (Plasma Derived Medicinal Products)
Guide
Has the page content helped you?

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
Has the page content helped you?

The Data Requirements for Human Drugs Submission

2022-10-13
The Data Requirements for Human Drugs Submission
Guide
Has the page content helped you?

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
Has the page content helped you?

Data Requirements for Veterinary Medicinal Products

2022-11-06
Data Requirements for Veterinary Medicinal Products
Guide
Has the page content helped you?

Good Manufacturing Practice (GMP) Guidelines

2023-01-05
Good Manufacturing Practice (GMP) Guidelines
Guide
Has the page content helped you?
Subscribe to Drugs