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History of Afghanistan Food and Drug Authority

The Food and Medicine Regulatory Authority, under the Ministry of Public Health of Afghanistan, is a national regulatory and technical body responsible for ensuring the safety, quality, efficacy, and lawful supply of medicines, health products, medical devices, food items, and related services. This authority plays a central role in public health protection, patient safety, and the regulation of the health market.

1. Initial Phase of Regulatory System Establishment
With the gradual development of the health sector in Afghanistan, the need to control medicines and food items became particularly apparent in the second half of the 20th century. During this phase, preliminary administrative structures were established under the Ministry of Public Health for the registration, import, and inspection of medicines. Despite their limited capacity, these structures laid the foundation for the basic concepts of medicine and food regulation.

2. Impact of Prolonged Instability and Conflicts
Due to decades of war, political instability, and administrative weakness, the regulatory system for medicines and food faced serious challenges. During this period:

  • Illegal imports of medicines and food increased;

  • Counterfeit, substandard, and non-compliant products entered the market;

  • Inspection, laboratory control, and law enforcement capacities were weakened.

Despite these challenges, the Ministry of Public Health made efforts within its available resources to protect public health from serious threats.

3. Phase of Regulatory Reforms and Fundamental Development
After 2002 (1381 AH), during the health sector reconstruction and reform process, medicine and food regulation became a government priority. In this phase:

  • Legal and regulatory frameworks for medicines, health products, medical devices, and food items were developed and enforced;

  • Standardized procedures for licensing, registration, evaluation, and marketing authorization were established;

  • National quality control laboratories were created and strengthened;

  • A pharmacovigilance system (monitoring medicine safety) was established;

  • Mechanisms for regulating and overseeing clinical trials were introduced.

4. Official Establishment of the Food and Medicine Regulatory Authority
To achieve greater cohesion, efficiency, and specialization in regulatory activities, the Food and Medicine Regulatory Authority was officially established as an independent authority within the Ministry of Public Health. As the National Regulatory Authority (NRA), it is responsible for:

  • Licensing facilities, activities, and human resources;

  • Technical evaluation and registration of manufacturing companies and products;

  • Issuing marketing authorization for medicines, health products, and food items;

  • Enforcing laws, regulations, and standards;

  • Quality control, laboratory testing, and post-market surveillance;

  • Leading and implementing the food safety system;

  • Supporting domestic production and promoting self-reliance.

5. Contemporary Phase and Strategic Focus
Currently, the Food and Medicine Regulatory Authority strives to align its regulatory system with internationally recognized standards, such as those of the World Health Organization (WHO) and the Codex Alimentarius principles. The authority emphasizes risk-based inspections, evidence-based decision-making, strengthening information systems, and professional capacity development.

The ultimate goal of these efforts is to ensure that the people of Afghanistan have access to safe, effective, high-quality, and accessible medicines and food items, while establishing a transparent, lawful, and standardized health market in the country.