Useful Links
EGYPT LINKS
- The Ministry of Health and Population
- Egyptian Medical Syndicate
- World Health Organization - Regional Office for the Eastern Mediterranean
- Egyptian Pharmacists Syndicate
- Egyptian drug agency
FDA REGULATIONS
- U.S. Food and Drug Administration
- Institutional Reiew Boards
- Protection of Human Subjects; Informed Consent
- FDA Individual Product Bioequivalence Recommendations
- Bioavailability & Bioequivalence Requirements
- Dissolution Methods for Drug Products
- Protection of Human Subjects
- Institutional Review Boards
- Bioavailability and Bioequivalence Requirements
- International guidelines
CLINICAL TRIALS & GCP LINKS
- ICH
- GCP EC
- Good Clinical Practice: FDA Consolidated Guidance
- Clinical Safety Data Management Definitions and Standards for Expedited Reporting
- Structure and Content of Clinical Study Reports - FDA
- Structure and Content of Clinical Study Reports - EMEA
- Financial Disclosure by Clinical Investigators
- Electronic Records; Electronic Signatures
- Guideline for Monitoring Clinical Investigations
- Clinicaltrials.gov
- Cancer.gov
- Centerwatch.com
REGIONAL BIOEQUIVALENCE REQUIREMENTS LINKS
- www.eda.mohp.gov.eg
- Saudi Arabia
- Gulf Countries GCC
- SGH
- GCC Bioequivalence requirements
- Saudi Arabia, Ministry of Health
- Saudi Arabia Bioequivalence requirements
- UAE Ministry of Health
- Kuwait Ministry of Health
- Bahrain Ministry of Health
- Qatar Ministry of Health
- Yemen Ministry of Health
- Oman Ministry of Health
- Jordan Ministry of Health
- Jordan JFDA