INVIMA ANNOUNCES NEW PROVISIONS TO IMPLEMENT RESOLUTION No. 1124 OF 2016 IN REGARDS TO THE BIODISPONIBILITY AND BIOEQUIVALENCE STUDIES
Through external circular DG 100-0175-17, the National Institute of Food and Drug Surveillance (INVIMA) developed the criteria and requirements for the Bioavailability and Bioequivalence studies in Colombia for the procedure implementations established in Resolution No. 1124 2016.
The external circular includes, amongst others, the following actions:
- The possibility for marketing authorization holders to submit the results of their bioequivalence studies in the period between the filing of the procedure for renewal of the marketing authorization and the beginning of the technical study done by the Medicine’s Department of INVIMA.
- Evaluate the possibility of granting an additional period for the holders to deliver the results of the bioequivalence studies during the renewal stage.
- Guidance provided by INVIMA to bioequivalence research centers and marketing authorization holders, in order to solve doubts and provide information for conducting bioequivalence studies.