Law No. 253 of 2022 establishing the National Drug Agency.

This Law, consisting of 24 articles, aims to restructure and manage the pharmaceutical sector to ensure the quality, safety, and efficacy of medications, recognizing these as core to public health and societal well-being. It (i) seeks to establish a comprehensive, science-based regulatory system for all health products, including supplements and natural products; (ii) provides a framework that guarantees product quality, affordability, and effective oversight for Lebanese consumers, fostering health security and elevating the professional transparency and competitive reputation of Lebanese pharmaceutical products.
The Law outlines the functions and structure of the Lebanese agency responsible for pharmaceutical and health product regulation as follows (i) organizational tasks, including ensuring product availability, quality, and safety, developing national product protection policies, updating relevant laws, and setting standards for product registration, import/export, pricing, and ethical promotion, alongside establishing good manufacturing, laboratory, and clinical practices; (ii) executive tasks involving implementing the policies, managing a central laboratory, overseeing pharmacovigilance, conducting research, representing Lebanon internationally, and managing emergencies like product shortages; (iii) regulatory role focusing on monitoring adherence to all established good practices and ethical standards in both domestic and foreign manufacturing. The agency is governed by a seven-member Board of Directors, comprising highly experienced specialists from various medical and scientific fields, who must meet strict nationality, civil capacity, and conflict-of-interest criteria.
Under Article 14, the Agency shall take the necessary measures to prevent dumping and monopoly in the market. In particular, Article 16 deals with the adrressing of crisis and establishes that the Agency is empowered with broad authority to analyze and mitigate risks to human, animal, or environmental health from pharmaceuticals, supplements, natural products, medical supplies, and vaccines by assessing and planning responses to identified hazards, informing the public and relevant authorities, and, in cases of confirmed danger, mandating actions like import/export bans, product withdrawal, re-export, or environmentally sound destruction, all while establishing a rapid alert system and coordinating with judicial bodies to halt production, seize products, and seal facilities during emergencies.