Medicines Regulatory Environment

The MoHSP is the highest level health authority. The National Health Superintendent-Supersalud is the head of SGSSS Inspection, Monitoring and Control (IMC). Two of SGSSS’ seven areas are specially relevant for medicines as regards Supersalud’s role: insuring the population and providing individual and collective healthcare [47]. Surveillance agencies for the production of goods and services for use and human consumption, supplies, facilities, and processes across the production chain are divided into three categories: health authorities, producers, and suppliers and consumers of these goods and services. Health authorities are the Ministry of Health and Social Protection, National Narcotics Fund-UAE, INVIMA, NHI, and the Territorial Entities (ETs) through the Territorial Directorates of Health (DTS).

The National Health Institute - (INS) is an autonomous entity linked to the MoHSP. It is responsible for epidemiologic surveillance. Since 2011, it is classified as a National Institute of Science and Technology of the General System of Social Security in Health and the Science, Technology and Innovation System. The INS also promotes, guides, implements, and coordinates scientific research in health and biomedicine; it is a national reference laboratory and manufactures biological products of interest to public health. The National Health Observatory is part of the INS and is responsible for the surveillance of public health information and provides policy recommendations [48].

The National Institute of Food and Medicines Surveillance, INVIMA, is an autonomous entity linked to the MoHSP. It is responsible for implementing IMC for medicines and other supplies that may impact individual and collective health. INVIMA has the power to issue regulations to develop the regulatory frameworks established by the MoHSP.

The Territorial Directorates of Health - DTS (departmental, district, and municipal level) is required by INVIMA to perform IMC of distributors and retailers of medicines establishments, such as pharmaceutical specialty agencies, warehouses, pharmacies, drug stores, and health food stores. Under the SGSSS Obligatory System for Quality Assurance in Health (SOGCS), the DTS is also in charge of IMC for health service providers (IPS and ESE), including pharmaceutical service providers.

The Institute of Technology Assessment in Health (IETS) is a nonprofit corporation with mixed public and private participation and own assets. Among their main functions is conducting health technology assessments based on scientific evidence, taking into account issues of safety, efficacy, effectiveness, and economic impact;

developing recommendations, guidelines, protocols, and generating information to facilitate decision making in the health sector, all at the request of the MoHSP [49].

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