Cuba: Guide for the Realization of Pharmacogenomic Studies, First in the Region
Resolution 75/2018 of the Center for the State Control of the Quality of Medicines and Medical Devices (CECMED) approves and enforces the Guide for the performance of pharmacogenomic studies during the development of medicines. According to CECMED, this guide is considered the first regulatory provision on the subject in the region. This provision sets the guidelines for conducting pharmacogenomic evaluations during the development of medicines of the national pharmaceutical industry.
The guide includes regulatory requirements for pharmacogenomic evaluation: the reception, coding and storage of samples, the use of biomarkers and the ethics of research. Pharmacogenomics allows therapeutic decisions to be guided by the molecular attributes of each patient, allows identifying patients who will respond to treatment, which implies an increase in therapeutic activity of incalculable scope, also has great impact in terms of safety, since the patients who will not respond, when not receiving the treatment, will be saved toxicities that would limit their quality of life, finally the impact on the efficiency, means a reduction of the direct costs of the medicines.
Source: CECMED, Dr. Diadelis Remirez (http://www.cecmed.cu/content/guia-para-la-realizacion-de-estudios-farmacogenomicos-primera-en-la-region)