The Ministry of Health of Colombia launched an open consultation to regulate the procedure for the registration and supply of new medicines in the public health system. According to the preliminary draft, it is expected to set the pharmacological, legal and budgetary evaluation times in 270 days.
The consultation will be held until February 5th. Afterwards, the ministry will observe the recommendations made and issue the decree, which will have a term of six months before its entry into force.
The draft decree will regulate article 72 of Law Nº 1753 of 2015. This article establishes that new drugs or those that must renew their license must be evaluated pharmacologically by the Institute of Health Technology Assessment (Instituto de Evaluación Tecnológica en Salud – IETS) within 180 days.
The IETS must classify the medicines in any of the six therapeutic-value categories based on the level of safety or efficacy compared to a similar medicine; being category 1 more effective than the chosen therapeutic comparator and category 6 as non-classifiable medication.
Then, the drug will be subject to a sanitary registry by the National Institute for Surveillance of Drugs and Food (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – Invima). Simultaneously, it will be priced by the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social – MSPS). This second step will have a term of 90 days, thus completing the 270 days since the medication was placed on the examination of the Colombian State.