EDA’s Requirements for BA/BE & Dissolution Studies

This regulation establishes clear standards for centers in Egypt that perform bioequivalence, bioavailability, and dissolution studies. For registration holders, CROs, and regulatory affairs officers, it provides a roadmap of what is required to ensure studies are acceptable, reproducible, and compliant with EDA expectations. It impacts generic product approvals, labeling, and market entry in Egypt.

Here are the principal components of the guideline:

Apply to licensed centers that conduct bioavailability, bioequivalence, and dissolution studies. Defines key terms: bioavailability, bioequivalence, biowaiver. Organizational & Operational Requirements The center must hold enough both the test and reference products to conduct studies. For modified-release dosage forms, studies in both fasting and fed states are required (except enteric/delayed-release where only fasting may suffice) with studies reported as separate files. Dissolution (in vitro) parts: must be done at various pH values (1.2, 4.5, 6.8) plus a suitable medium (FDA / USP or other recognized pharmacopeias) unless alternative justified.

Centers must notify the EDA’s Protocol Evaluation & Monitoring Unit for Bioavailability/Bioequivalence Studies in advance—no less than 3 working days and no more than 2 weeks before start of each study.

Before starting, the center must submit certain details: product name, dosage form, active ingredient, manufacturer/license holder, study design and whether fed/fasting, etc.

List of volunteers, volunteer identification (civil ID), demographic data, signed informed consent in Arabic, IRB (Ethics Committee) approval. Health screening required: complete blood picture, liver & kidney function, serology (HIV, HCV), drug abuse tests, etc. Adverse event monitoring during study; ability to handle serious events.

Protocol must include test/reference product data, randomization, washout periods, sample collection schedules, phases/stages (especially if multi-stage), inclusion/exclusion criteria, dosing administration, etc.

Sampling, analysis, data management, labeling of samples, storage conditions (e.g., deep freezers at -80°C for biological samples) are specified.

Final study report plus raw data, documentation of all study materials, reference and test product packaging.

Retention of biological samples (after analysis) and retention of all study records for no less than 5 years after approval by EDA.

GCP (Good Clinical Practice) requirements apply. Centers must follow ethical and procedural standards.

Staff roles must be clear: Director, Quality Assurance, Technical/Analytical heads etc., must be present or officially delegated.