Regulatory Intelligence Pack: Middle East & Africa

English

Expanding into emerging markets requires access to reliable, practical information that is often difficult to obtain.

This curated Regulatory Intelligence Pack brings together a selection of country overviews covering key markets across the Middle East and Africa. Each article, written by local or subject-matter experts, provides a structured analysis of the medical device regulatory framework, including market access pathways, local requirements, and practical considerations for manufacturers.

The markets covered in this pack are characterised by ongoing regulatory development, varying levels of transparency, and limited availability of consolidated guidance in English. As a result, companies frequently face challenges not only in interpreting requirements, but in understanding how they are applied in practice.

 

Included markets:

• Saudi Arabia
• Jordan
• Iran
• Tunisia
• South Africa
• Uganda
• Botswana

 

Who is this for?

This pack is particularly relevant for:

• regulatory affairs professionals managing international portfolios;
• companies planning or expanding into Middle East and African markets;
• consultants and advisors supporting global market access strategies.

While each article can be purchased individually, this curated pack provides a more efficient and cost-effective way to gain a broader regional perspective and compare regulatory approaches across multiple jurisdictions.

 

About the authors:

Ilona Putz
Owner of PULONA Emerging Markets FZE, United Arab Emirates
With over 25 years of experience in the Middle East, PULONA offers a wide range of professional services to companies in the pharmaceutical, medical equipment and medical supplies sectors. PULONA has an established network of distributors across the region that can provide optimum sales, marketing and customer services to its clients.

Dennis W Mwesigwa
Director of Inspectorate and Enforcement and Chief Inspector of Drugs at the NDA in Uganda
With over 25 years of experience in pharmaceutical regulation, he has played a central role in strengthening compliance with GMP, licensing of drug outlets, PMS, and enforcement of national drug laws. He has held several senior roles within the NDA, including Manager GMP/GDP/GPP, Senior Inspector of Drugs, and Acting Head of Inspectorate Services. He has led numerous local and foreign inspections of pharmaceutical and medical device manufacturers and contributed to regulatory harmonisation efforts within the East African Community. His leadership was instrumental in the NDA’s designation as a Regional Centre of Regulatory Excellence in manufacturing and licensing under NEPAD. He is a certified GMP auditor and an active member of several high-level technical working groups under the African Medicines Agency and the WHO, where he has also served as an observer inspector under the WHO Collaborative Procedure. He is a member of the National Standards Council of the Uganda National Bureau of Standards and serves as a visiting lecturer at Makerere University School of Health Sciences. He holds Master’s degrees in Pharmaceutical Sciences, International Public Health, and Business Administration, with published research in pharmaceutical synthesis, drug management, and access to quality medicines.

Brenda Kitimbo
Manager – Medical Devices at the NDA
Recognised for her exceptional ability to translate abstract concepts and strategies into concrete, actionable plans. Her career journey includes significant experience in manufacturing, supply chain management, distribution, and QMS, giving her a comprehensive understanding of the entire product lifecycle. Furthermore, her background as an Inspector of Drugs highlights her deep knowledge of regulatory compliance and quality assurance within the pharmaceutical and medical device sectors. With a strong academic foundation, Brenda holds a Bachelor’s degree in Pharmacy from the University of Pune, India and a Master’s degree in Biotechnology Innovation and Regulatory Sciences from Purdue University, USA.

Michael R Mutyaba
Manager of Traditional, Complementary, and Health Products at the NDA in Uganda
He holds an MSc in Formulation Development and has led the development of key regulatory frameworks for medicines and medical devices. His previous roles include serving as a WHO Temporary Adviser under the Medicines Prequalification Project and representing the NDA in the East African Community’s Technical Working Group on Drug Safety and Efficacy. He is also a member of the Global Antibiotic Resistance Partnership Uganda Working Group.

Rachel J Mujawimana
Inspector of Drugs at the Uganda NDA
She has a focus on the regulation of medicines and medical devices. She holds an MSc in Pharmaceutical Sciences from Trinity College Dublin, a BPharm (Hons) from Universidad de Oriente, Cuba and an MBA from the Uganda Management Institute. Rachel brings extensive expertise in GMP inspections, QMS, and import/export verification, among other core regulatory functions. She is a member of the NDA Scientific Advisory Committee and has completed coursework for a Specialist Diploma in Medical Device Science at the University of Galway, pending final results. Her interests include regulatory system strengthening and advancing medicines and medical device oversight in low- and middle-income countries.

Olfa Ben Smida
Pharmacist, and Head of Department of Pharmaceutical and Para-pharmaceutical Product Marketing at the DPM since 2019
She started to work at the DPM in 2015 as a Pharmacist Assessor of medicines’ dossiers before joining the CTI equipment in 2017. She worked as a Regulatory Affairs Pharmacist in a multinational from 2011 to 2015 and as a Pharmacy Assistant in community pharmacy from 2009 to 2011.

Oumayma Ouerghemmi PharmD
Resident in Hospital and Industrial Pharmacy; Pharmacology field since January 2022 with six months’ internship in clinical pharmacy, six months in hospital pharmacy, and six months at the DPM. Currently, she is a pharmaceutical production resident in a multinational company. She is also undergoing an eLearning course in Economic Evaluation in Global Health by the University of Washington.

Abderrazek Hedhili
University Hospital Professor of Toxicology
He is the general manager of the DPM as well as the chair of the Laboratory of Toxicology and Environment (LR12SP07). He is a World Health Organization Expert. He is a member of the French Academy of Pharmacy and a member of IFCC/AFCB.

 

All of these articles have been published previously in the Journal of Medical Device Regulation. They are also for sale individually through our Middle East & Africa Regulatory Knowledge Hub.