Approach of the Cuban regulatory authority to natural and traditional medicine regulations

INTRODUCTION: Natural and traditional medicine (NTM) has gained space in Cuban health and society. OBJECTIVES: characterize NTM regulations and contribute to their development by means of the retrieval of national regulations about standards for NTM drugs and medical devices. METHODS: a descriptive cross-sectional retrospective study was conducted. The regulatory bases were retrieved from a review of scientific papers published between 1989 and 2012, as well as work sessions with key officials and interviews with experts. RESULTS: a total 22 regulations were collected. The Center for State Control of the Quality of Drugs and Medical Equipment (CECMED) was identified as among the 6 main regulators in this field, with 5 institutions regulated. CONCLUSIONS: for the first time a general overview was provided of the evolution of NTM regulations, their milestones, structures and development needs. It was shown that CECMED has accomplished the mandate of the Council of Ministers about regulation in this field, and that it investigates strategies aimed at fulfilling the directives received in relation to the transformation of the Cuban economic and social development model ensuring the quality, safety, efficacy and efficiency of NTM drugs and medical devices to preserve the right of Cubans to health care.