Inspection readiness
Mock audits, gap assessment and corrective and preventive action review.
The Office
Arab expertise. A clear technical reference.
The Arab Experts’ Office is the technical arm of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, bringing regulatory, industrial and academic experience together across 22 Arab markets.
The Union since 1986 · Office established 3 May 2026Vision & mission
Our vision
Support, develop and localise the pharmaceutical and medical-device industry across Arab countries, bringing manufacturers and medicines authorities together on one platform.
Our mission
Provide specialised technical consultancy across pharmaceutical disciplines.
Develop Arab professional capability through specialist training.
Contribute to unified pharmaceutical guidance in coordination with regulatory authorities.
Provide a platform for technical arbitration and review of sector-specific disputes.
Industry support
Practical support across product development, manufacturing, inspection readiness, registration and market access.
Registration
Dossier preparation, review and deficiency responses across the technical modules.
Bioequivalence & clinical studies
Support for study design and protocol and clinical study-report review.
Quality systems & data integrity
Pharmaceutical quality systems, data governance and lifecycle validation.
Biosimilars & medical devices
Development strategy and market-access pathways.
Corporate training
Programmes for quality, regulatory affairs and production teams.
Building regulatory authority capability
The Office’s programme includes inspector training, knowledge exchange and quality-system readiness for Arab authorities preparing PIC/S pre-accession applications. The current website records an authority training programme including a Syrian Ministry of Health cohort.
Governance & responsibilities
Named responsibilities for scientific standards, regulation, quality, training and administration, with sources, review dates and corrections retained.
Prof. Dr. Osama Abd Elrahman
Overall scientific standard and Office chairmanship.
Dr. May Ahmad
Registration, biosimilars and regulatory datasets.
Dr. Samah Shawakat
Quality, medical devices and manufacturing practices.
Dr. Khalid Ahmad Shalaby
Capability building and learning content.
Trust & corrections
Check the source, date and regulatory status whenever you use a reference or tool.
Primary sources
References draw on official medicines authority documents, standards, guidance and assessment reports.
Status & review date
Distinguish drafts, final documents and estimates, and check when the information was last reviewed.
Corrections
Send the Office the relevant tool or dataset and the supporting document for a proposed correction.
Data & privacy
Existing tools and forms remain subject to the published privacy policy. Consult it for their data-handling practices.
Global engagement
The following contributions and invitations appear in the Office’s published record. The current record remains the reference for details and documents.
Comments on general considerations for the use of New Approach Methodologies in drug development.
FDA-2025-D-6131-0002Comments on non-inferiority and equivalence comparisons in clinical trials.
EMA/301654/2025Comments on the working document for bioequivalence of immediate-release oral dosage forms.
QAS/25.990The website records an invitation issued on 11 June 2026 to AUPAM through the Experts’ Office for the WHO Geneva consultation on health-product manufacture and inspection scheduled for 1 July 2026.
Open the detailed recordArab markets
Find national medicines authorities and their information in the current atlas, with its stated verification dates.
- Jordan
- United Arab Emirates
- Bahrain
- Tunisia
- Algeria
- Djibouti
- Saudi Arabia
- Sudan
- Syria
- Somalia
- Iraq
- Oman
- Palestine
- Qatar
- Comoros
- Kuwait
- Lebanon
- Libya
- Egypt
- Morocco
- Mauritania
- Yemen
Cooperation
Regulatory authorities
Reliance, harmonisation, inspector training and knowledge exchange.
Industry
Inspection readiness, registration, bioequivalence and quality systems.
Universities
Joint research, scientific publishing, training and knowledge transfer.