Regulatory Issues

The pharmaceutical sector in Saudi Arabia is undergoing rapid transformation, driven by evolving regulations, increasing oversight, and a growing national commitment to local manufacturing and innovation. For companies operating in this sector, navigating the legal and regulatory landscape has become as essential as research, development, and commercialization.

At Kadasa IP, we advise pharmaceutical manufacturers, distributors, innovators, and research entities on all aspects of the Saudi regulatory framework while safeguarding their intellectual property rights. Our practice integrates deep knowledge of pharmaceutical law, patent strategy, and the region’s dynamic regulatory environment.

We support clients throughout the full product lifecycle—from obtaining Marketing Authorization (MA) from the Saudi Food and Drug Authority (SFDA) to ongoing compliance with pharmacovigilance, labeling, manufacturing, importation, distribution, and promotional requirements.

Our attorneys advise on the regulatory implications of patents, including the interaction between patent protection and SFDA market-entry procedures, protection of undisclosed test data under Saudi regulations and TRIPS obligations, and measures to reduce the risk of premature generic competition.

Kadasa IP assists clients in securing the required operational licenses, managing contractual arrangements with local partners and agents, and ensuring alignment with SFDA standards on product labeling, safety monitoring, advertising, digital promotion, and renewals of marketing authorization.

Beyond regulatory compliance, we counsel clients on ethical and legal conduct within the pharmaceutical sector, including:

• Anti-bribery compliance under the Saudi Anti-Bribery Law
• Conflict-of-interest management
• Compliance with SFDA’s Code of Ethical Promotion for Pharmaceuticals
• Internal policies and training to strengthen corporate integrity

As Saudi Arabia accelerates investment in life sciences under Vision 2030, opportunities for pharmaceutical innovation continue to expand—along with regulatory responsibilities. With a multidisciplinary team that understands the intersection of law, science, and regulatory policy, Kadasa IP enables clients to operate confidently and strategically, turning regulatory compliance into a competitive advantage rather than a constraint.