Pharmaceutical products intended both for the Kenya market as well as products intended for export will be registered with the Pharmacy and Poisons Board. The following criteria will be used in the registration:

(1) Proven quality, safety and efficacy.

(2) Specific medical need; new drug entities and drug combinations should have an added advantage over the already registered product.

(3) Proposed wholesale and retail prices; products whose prices are excessive compared to those already registered for the same therapeutic indications will not be accepted.

(4) Unique characteristic of the drug product such as life-saving and orphan drugs. Orphan drugs are products for rare conditions for which the small size of the local market would make registration otherwise commercially unattractive.

The registration fee will be waived for orphan drugs. New investigational drugs will be considered for exemption from normal registration requirements in order to facilitate their availability for clinical studies.