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National Medicines Regulatory Authority (NMRA) > Regulatory Functions
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Regulatory Functions

Regulatory Functions for National Medicines Regulatory Authority (NMRA), Ministry of Health & Human Services, Federal Republic of Somalia

The NMRA is mandated to safeguard public health by regulating the quality, safety, and efficacy of medicines and health products. Our regulatory functions ensure that all medical products circulating in the country are appropriately evaluated, authorized, monitored, and controlled throughout their lifecycle.

Our Regulatory Functions are as follows:

 

  1. Marketing Authorization (Product Registration)

We evaluate and approve medical products before they reach the market. This includes reviewing safety, quality, and efficacy data to ensure products meet national and international standards. Only authorized products are allowed for importation, distribution, and use.

  1. Licensing & Good Pharmacy Practice (GPP)

NMRA licenses pharmaceutical professionals, retail and wholesale outlets, and manufacturing facilities. We promote Good Pharmacy Practice (GPP) and oversee continuous professional development (CPD) to ensure safe and ethical practices across the supply chain.

  1. Regulatory Inspections

Our inspection teams assess pharmaceutical facilities—including pharmacies, distributors, and manufacturers—to ensure compliance with licensing conditions, Good Manufacturing Practice (GMP), and storage guidelines. Non-compliance is addressed through corrective actions and enforcement measures.

  1. Clinical Trials Oversight

We regulate the conduct of clinical trials to ensure that they are ethically approved and scientifically sound. The protection of human subjects and adherence to international research standards are our top priorities.

  1. Market Surveillance and Control

Post-market surveillance activities allow us to monitor medicines and health products on the market. We actively investigate reports of substandard, falsified, or counterfeit products, taking swift action to withdraw them and protect the public.

  1. Pharmacovigilance and Vigilance Systems

We operate an adverse drug reaction (ADR) reporting system to collect, assess, and act on drug safety data. This helps identify and mitigate risks associated with medicines once they are in use.

  1. Quality Control (Laboratory Testing & Lot Release)

Our laboratory services conduct rigorous testing of medicines to confirm compliance with approved standards. We also implement lot release procedures to verify the quality of certain high-risk products before market entry.

  1. Online Regulatory Systems

We have introduced digital platforms to streamline registration, licensing, inspection scheduling, and reporting. These systems enhance efficiency, transparency, and data-driven decision-making across all regulatory functions.

  1. Narcotics and Psychotropic Substances Control

The NMRA regulates the use, importation, and distribution of controlled substances including narcotics and psychotropic drugs. We ensure these substances are used strictly for medical and scientific purposes and prevent their diversion and misuse.

  1. Control of Medical Product Promotion and Advertising

We monitor and regulate promotional materials, advertisements, and public information related to medical products to ensure accuracy, ethical standards, and compliance with regulatory guidelines. This protects consumers from misleading or false claims.

  1. Tobacco Control and Regulation

In line with national health policies, the NMRA contributes to tobacco control by regulating tobacco products and enforcing related legislation. This includes packaging, labeling, advertising, and public health education to reduce tobacco use and its harmful effects.