3. Relevant Documents

This guidance should be read in conjunction with:

 The Gulf Cooperation Council (GCC) data requirements for human drugs submission

 Regulatory framework for drugs approval

 The bioequivalence guideline

 Clinical considerations for vaccines

 Guidelines on Biosimilar Products: Quality Considerations

 The GCC Guidance for presenting the labeling information, Summary of product characteristic (SPC) and Patient information leaflet (PIL).

 Guidelines for variation requirements

International Council for Harmonization (ICH) guidelines:​

 ICH E1: Clinical Safety for Drugs used in Long-Term Treatment

 ICH E3: Clinical Study Reports

 ICH E4: Dose-Response Studies

 ICH E5: Ethnic Factors 

 ICH E6: Good Clinical Practice

 ICH E7: Clinical Trials in Geriatric Population

 ICH E8: General Considerations for Clinical Trials

 ICH E9: Statistical Principles for Clinical Trials

 ICH E10: Choice of Control Group in Clinical Trials

 ICH E11: Clinical Trials in Pediatric Population

 ICH E12: Clinical Evaluation by Therapeutic Category

 ICH E17: Multi-Regional Clinical Trials

 ICH E19: Safety Data Collection

For biological products containing blood products and biosimilars medicines, please refere to European Medicinal Agency (EMA) guidelines on blood products including biotech alternatives (https://www.ema.europa.eu). ​