Russian pharmaceutical manufacturers are increasingly looking toward the GCC and MENA regions. But "entering" and "establishing a foothold" are challenges of entirely different magnitudes.
The two key markets in the region — the UAE and Saudi Arabia — despite their undeniable appeal, require fundamentally different approaches.
Together with the Pharvestnik Magazine, Julia Kuzmenko, Counsel and Head of Regulatory Practice at Lidings, examined the nuances of the regulatory architecture in these two jurisdictions.
For the full analytical materials, see the Pharvestnik Magazine publications (in Russian only) here and here.
Below, we share a brief overview and key takeaways:
UAE: a hub where success hinges on entry strategy
$9 billion — the projected volume of the UAE pharmaceutical market by 2031. 80% of products are imported, while the government is actively driving localization: over 20 manufacturing plants are already operating, and by 2030, local production volumes are expected to triple.
Key developments: the establishment of the Emirates Drug Establishment (EDE) as a "one-stop shop," and the agreement on recognition of Russian GMP standards (2025).
Saudi Arabia: high appeal, but a more demanding approach
$12–15 billion** — current market size, projected to reach **$15.9 billion by 2030. The largest pharmaceutical market in the MENA region. 40 local plants cover only 36% of demand; the rest is imported.
Market entry is more challenging: halal certification, stringent dossier requirements, and lengthy procedures. However, the registration validity period for dietary supplements is longer here — 3–5 years, compared to 1–2 years in the UAE.
Understanding the regulatory environment
Any market analysis inevitably comes down to the legal architecture of each jurisdiction.
"In the UAE, for example, the first stage is 'immersion' — a thorough analysis of the legal environment of the target jurisdiction where the manufacturer plans to operate. This includes not only regulatory and financial aspects but also the specifics of the chosen economic zone. In the UAE, for instance, there is a distinction between the mainland (Abu Dhabi, Dubai) with strict local rules and free zones with preferential regimes," explains Julia.
In Saudi Arabia, the approach is different — here, preliminary product classification through the SFDA platform is essential. For dietary supplements, one must also consider the blurred line between food supplements and herbal products, as well as the need for individual approval of health claims.
What both markets have in common: all products must undergo state registration. Dossiers are submitted through a local Marketing Authorization Holder (MAH); bilingual labeling (Arabic + English) and a well-established pharmacovigilance system with a designated QPPV are mandatory.
Beyond the UAE and Saudi Arabia
In the MENA region, Qatar, Oman, Bahrain, and Kuwait are also generating steady demand — particularly for oncology drugs, insulins, and biotech products. Each of these countries has its own regulatory logic, localization requirements, and registration nuances.
Moreover, other jurisdictions beyond the Middle East are worth considering — Southeast Asia, North Africa, and even select markets in Latin America, where Russian pharmaceutical manufacturers are also gradually beginning to gain traction.
Each of these entry points has its own specifics, regulatory landscape, and barriers. The question is not where to go, but how to chart the route.
That is precisely why we have developed Lidings Global — a dedicated practice that supports Russian companies in entering foreign markets.
Within our regulatory practice, we don't just advise on formal requirements — we help clients build a full-cycle engagement framework with regulators: from preliminary product classification to post-registration support.