CLEAR RULES FOR PHARMACEUTICAL MARKETING AUTHORIZATIONS
The Colombian Regulatory Authority (INVIMA), demands the submission of bioequivalence and bioavailability studies in order to grant marketing authorizations. Said studies seek to demonstrate the quality, efficacy and safety of one type of drug in comparison to another one containing the same principle and dose, and to analyze the drug’s capability to act in a particular time frame and site.
Before the existence of INVIMA’S Resolution No. 1124, all people or entities seeking to obtain a marketing authority for a drug, had to provide the bioequivalence and bioavailability report without the possibility of validating the studies already approved by foreign competent authorities. With today’s regulation it is possible for applicants to use reports approved by foreign authorities in Colombia.
The mentioned resolution applies to institutions that carry out bioavailability and bioequivalence studies, as well as to chemical synthesis products that require said studies (namely, those that contain at least one of the active ingredients included in the list of said resolution). Therefore, not all generic drugs must have the corresponding studies.