ECUADOR

On November 19, the National Agency of Regulation, Control and Sanitary Surveillance (ARCSA in Spanish) put into consultation the Technical Sanitary Regulation for the approval of clinical trials and certification of products for human use and consumption during health emergencies. The purpose of the regulation is to establish the provisions for ARCSA’s approval process for clinical trials of investigational products, together with the certification of good practices and sanitary of medicines and the establishments that produce them. Interested parties may submit their comments until December 3, to the following e-mail address: [email protected]. The comments form can be downloaded by clicking here.

The regulation in consultation indicates that the holders of the sanitary certificates and good practices of medicines must keep constantly updated the information and requirements provided in the processes of registration, modification or renewal of such certificates. It also indicates that in order to carry out a clinical trial in Ecuador, any national or foreign legal entity that is a sponsor of the trial is required to request prior authorization from the sanitary entity.

In addition, in terms of certification of foreign products for human consumption and use, the text mentions that the applicant may submit to ARCSA the current electronic certificates issued by Regional Reference Agencies qualified by the Pan American Health Organization (PAHO), so that they can support the technical information requested in the process of initiating the registration of the health certificate. In case the certificates are national, ARCSA may extend the validity of the certificates of good practices for a period of two years in addition to the original term.

Finally, the text establishes that the suspension of the sanitary certificate of the drugs also implies the prohibition of their manufacture, import, export and commercialization and their immediate withdrawal from the market. Thus, the sanitary agency will notify the holder of the sanitary certificate of such action.