The Regulatory Environment of MENA
In our previous article on the Middle East and North Africa (MENA), we saw that the number of high-quality sites and investigators is a big draw for sponsoring clinical trials in the region. Another big reason people are choosing to perform their clinical trials in the MENA region is the presence of a fully functional and transparent regulatory system. In terms of regulatory compliance, MENA follows ICH-GCP standards and each constituent country also has its own, independent, national regulations.
This is much like the regulatory landscape in Europe. However, there is a large number of languages used in Europe and the associated complexities of translating clinical trial documentation in multinational European trials quickly becomes a rate-limiting factor. In the 22‑country region of MENA, however, there are only two languages. The official language is Arabic, so any documents intended for use by the patient, such as informed consent forms and patient diaries need only be in the Arabic language. In countries where French is also spoken, i.e., Algeria, Morocco, and Tunisia, a second translation into French for the above documents would be required.
The countries taken as examples below illustrate the similarity between the nations’ regulatory bodies which all follow ICH-GCP, but differ in their names, procedures and timelines.
The Egyptian Drug Authority (EDA) is an organization within the Ministry of Health that is responsible for safeguarding health by regulating the safety and quality of medicines, biologicals, medical devices, cosmetics, dietary supplements and pesticides. The EDA has three suborganizations that work cooperatively and synergistically to assure the achievement of the EDA’s mission. These organizations are called:
- Central Administration of Pharmaceutical Affairs (CAPA),
- National Organization for Drug Control & Research (NODCAR), and
- National Organization For research & Control of Biologicals (NORCB).
The regulatory bodies in the United Arab Emirates are the Ministry of Health, Dubai Health Authority and the Health Authority of Abu Dhabi, all of which are considered as important regulatory authorities in matters of approval for different centers where the study will be conducted and performed.
The Jordanian Food and Drug Administration (JFDA) has implemented applicable clinical trial law since 2001, and in Saudi Arabia, the Saudi Food and Drug Administration (SFDA) is the regulatory authority responsible for clinical research in its country. The SFDA was established in 2003 and adopts many of the regulations mandated for clinical trials by the United States of America’s USFDA.
As timelines and processes differ from country to country, it is a wise move to partner with a CRO, such as Europital, that has the necessary knowledge about the region and capable of advising and implementing strategies arising from the project’s risk management plan. These practical, risk-based strategies could include:
- Providing the optimal submission procedure in each country,
- Overseeing investigational sites, and
- Overcoming any challenges to importing drugs.
In this short article we have seen that MENA has a systematic regulatory environment with timelines that can be predicted and planned to fit within a sponsor’s timelines.
About Europital
Europital is an international CRO providing a full range of clinical research services. Since 2010, the Europital team has been working hand-in-hand with our clients on projects that span from First in Human studies to pivotal, international studies conducted across multiple continents.
In addition to its regional offices in Europe, Europital has built a global network of trusted partners over the last 10 years in the Middle East and North Africa, USA, Canada, Russia, India and Australia.
Europital’s readiness, reliability and flexibility all mean we are committed to the success of clinical projects worldwide.
Regardless of where your study sites may be, contact Dave to learn more about how we can help with all your clinical research needs.
David Bruce MBA PhD
Business Development Manager
T: +44 (0) 1743 367696
M: +44 (0) 7850 123151
E: [email protected]