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).