The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is the Statutory National Medicines Regulatory Body for Zambia established under an Act of Parliament, the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate and control the manufacture, importation, storage distribution, supply, sale and use of medicines and allied substances. The main objective of the Authority is to ensure that all medicines and allied substances being made available to the Zambian people consistently meet the set standards of quality, safety and efficacy

Mission Statement

To effectively regulate and control Medicines and Allied Substances made available to the Zambian population to ensure their conformity to set standards thereby safeguarding public health.

The functions of the Authority are stipulated by the Medicines and Allied substances Act (No. 3) of 2013 are to:

a) Grant pharmaceuticals license and marketing authorisation.
b) inspect any premises used for the purpose of manufacturing, distribution, sale, importation or exportation of  medicines or allied substances
c) Regulate and control the manufacture, importation or exportation, distribution, sale of medicines and allied  substances
d) Regulate and control the advertisement and promotion of medicines and allied substances
e) Register and regulate pharmacies, health shops and ago-veterinary shops.
f) In consultation with relevant professional bodies, establish, maintain and develop standards for the operations of pharmacies, health shops, and agro-veterinary shops.
g) Serve and protect the public interest in all matters relating to the sale of medicines and allied substances.
h) Regulate and monitor the conduct of clinical trials
i)  Establish, maintain and enforce standards relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances
j)  Conduct post-market surveillance
k) Establish, maintain and enforce standards for drug quality control laboratories
l)  Advise the minister on policies relating to the regulation and control of medicines and allied substances
m) Collaborate with corresponding medicines regulatory authorities in other countries
n) In consultation with the relevant research institutions, determine national priorities in pharmaceuticals research
o) and do all such things as are connected with or incidental to the functions of the Authority