Executive Branch formalizes criteria and requirements to demonstrate bioequivalence in medicines
22 diciembre 2021


On December 22, the Executive Branch made official the Instructions on criteria and requirements to demonstrate bioequivalence and bioavailability in drugs for human use and consumption. This regulation establishes the requirements to be presented by the entities or centers interested in carrying out this type of studies. Likewise, the instructions state that the regulatory entity will be in charge of determining and updating the list of active ingredients that require “in vivo” and “in vitro” bioequivalence studies, as well as the list of comparator drugs. The resolution is already in force.

In this regard, a bioequivalence study must be carried out according to an agreed protocol, which will be signed by the investigator and the sponsor. Within this protocol, the objective of the study and the procedures to be performed, the reasons for proposing the study in humans, the nature and extent of the known risks will be indicated. For this purpose, the National Agency for Regulation, Control and Health Surveillance considered the following criteria to determine the active ingredients that require the submission of “in vivo” or “in vitro” bioequivalence studies:

  • Medicines with narrow therapeutic margin;
  • Medicines classified as high health risk;
  • Drugs with a half-life of more than 12 hours;

For active principles considered “too potent or too toxic” to be administered at the highest dose to healthy volunteers, it is recommended that the study be conducted using the active principle at a lower dose in healthy volunteers. Whereas for active substances that show unacceptable pharmacological effects in healthy volunteers, even at lower doses, a study in patients will be necessary. In this regard, depending on the dosage posology, a multiple dose study, i.e. a steady state study, may be required.