Regulatory
Rapporteur
Write to the Editor at publications@topra.org
April 2025 | Vol. 22 | No. 4
EDITORIAL
Africa and the MENA region: Opportunities for growth
The April issue of Regulatory Rapporteur focuses on Africa and the Middle East and North Africa (MENA) region. This vast area of the globe encompasses 71 countries and, with a population of approximately 1.7 billion people, represents a multitude of languages, cultures, economies and demographics.
While the diversity of approaches and processes to drug registration brings challenges for approval and regulation, there are also many opportunities for innovation and growth. In this issue, we explore Africa’s potential, in particular for research and clinical trials, and its evolving regulatory frameworks governing pharmaceutical registration and pricing.
By Sobhey Nassar
FOCUS
Clinical research in Africa: Regulatory environment, challenges and opportunities
Understanding the evolving regulatory landscape is essential for stakeholders aiming to conduct or support research in Africa. This article looks at the unique challenges facing healthcare companies and research institutions but shows how regulatory harmonisation, capacity building and investment in infrastructure can help unlock Africa’s potential as a key player in global clinical research.
By Yvette Goedhart and Heba Hashem of PPD, part of Thermo Fisher Scientific
FOCUS
A comprehensive analysis of drug pricing mechanisms and the regulatory framework in Morocco
Access to affordable medication is crucial for equitable healthcare systems, but balancing drug pricing and accessibility is challenging. This article provides a review of pharmaceutical pricing and reimbursement policies in Morocco, traces the historical evolution of drug pricing mechanisms, and explains their role in the drug registration process.
By Hicham El Horr, Mohamed Yafout, Youssef Khayati and Sanae Derfoufi of the Faculty of Medicine and Pharmacy at the Hassan II University of Casablanca, Morocco
FOCUS
Deciphering the regulatory landscape of MENA markets: Challenges in pricing and ancillary issues
Each country in the MENA region has distinct regulatory requirements, necessitating a comprehensive knowledge of local guidelines to ensure compliance and streamline product approvals. This article provides an in-depth analysis of major regulatory hurdles in the region owing to external reference pricing (ERP) and inconsistent dossier requirements, and offers strategic solutions to facilitate smoother market entry.
By Sukesh Bhardwaj, Sri Pranavi Bolla, Vishal Jain, Kirti Yadav, Vivek Tomar and Allison Gillespie of Syneos Health
FOCUS
Regulatory governance for medical research in the United Arab Emirates: A comprehensive overview
This article provides a comprehensive overview of the UAE’s research governance structure and highlights its requirements and applicable legislation, both at federal and local levels. It explores the functions of its regulatory authorities, the ethics review process and how the regulatory framework is continually evolving to align with international best practices.
By Dr Marie Ibrahim of IROS CRO
STANDALONE
Essential steps for a successful Notified Body application in medical devices and in vitro diagnostic products
Navigating the notified body (NB) application process is a critical step for manufacturers seeking CE certification for medical devices under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). This article outlines the essential steps for a successful NB application, highlights evolving regulatory expectations and provides strategies to mitigate risks and facilitate the application process.
By Dr Nisha Vempalle of RegTrac
STANDALONE
Making the move from regulatory affairs: Transferring your skills to the wider pharmaceutical industry
Regulatory affairs can be an excellent springboard into careers across the pharmaceutical industry. This article, based on a personal experience of transitioning from a regulatory affairs role to a management associate role, highlights the skills and knowledge a regulatory affairs professional has which can be applied and transferred to either an expanded role within the regulatory function or to a new role in the wider industry.
By Helen Donnelly of Mundipharma, UK
If you’re interested in this subject, find out more about our upcoming Masterclass for regulatory affairs professionals who want to develop their understanding of all aspects of regulatory operations in the MENA region.
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