Published on Sep 25, 2025
Pharmaceutical regulatory affairs in the MENA (Middle East and North Africa) region face numerous challenges due to regulatory diversity, evolving frameworks, and varying levels of infrastructure. One of the most significant issues is the lack of harmonization across countries. Each nation—such as Saudi Arabia, Egypt, Iran, and Algeria—has its own regulatory authority, requirements, and timelines, making it difficult for companies to follow a unified process. Efforts like the Gulf Cooperation Council (GCC) have tried to streamline registration procedures, but implementation remains inconsistent.
Regulatory systems in many MENA countries are rapidly evolving, which leads to frequent updates in laws and guidelines. While this is a sign of progress, it creates challenges for pharmaceutical companies trying to stay compliant in a constantly shifting environment. In some countries, digital infrastructure is still underdeveloped, meaning submissions may need to be done manually, and electronic systems like eCTD are not widely adopted. In other countries online submission in eCTD are mandatory for a long time.
Product registration delays are another common problem. Approval timelines can be long and unpredictable due to bureaucratic process or limited regulatory resources. Furthermore, importation and distribution rules can be complicated, with strict licensing requirements and additional barriers for certain drug categories, such as biologics or controlled substances.
Some countries also impose local manufacturing requirements, which may involve complex GMP inspections or tech transfer obligations.
As pharmacovigilance systems expand, post-marketing surveillance expectations are growing, but standards vary by country. Market access issues such as pricing regulations, reimbursement challenges, and reference pricing further complicate the landscape.
In addition, political instability in parts of the region and cultural considerations can influence regulatory decisions and timelines. Overall, navigating pharmaceutical regulatory affairs in MENA requires deep regional knowledge, flexibility, and continuous adaptation to a dynamic and often fragmented system.
Join our train course Pharmaceutical Regulatory Affairs in the Middle East and North Africa to get an essential overview of the key areas of pharmaceutical regulatory affairs in the region. This course will focus on practical aspects and will cover the regulatory requirements and developments in the individual countries as well as discuss harmonisation in the region.