MEXICO

On March 10, the Federal Commission for Protection against Health Risks (Cofepris, in Spanish) announced that it was making progress with a new notification mechanism for pharmaceutical laboratories so that they can share information on any problems related to medicine and vaccine safety. Cofepris urged the laboratories in the test Pilot Group (Pfizer, Eli Lilly, Bayer, Sanofi Aventis, Novartis Pharmaceutical, and Abbvie Pharmaceuticals) to send 10 notifications using the new XML-E2B file to inform the National Center for Pharmacovigilance (CNFV, for its acronym in Spanish) of these events. The mechanism is however still at a preliminary stage of implementation, although it could be extended to the rest of the industry in the medium term.  The Ministry of Health also announced that it is developing actions with national laboratories to manufacture oncological drugs at local level.

The new mechanism complies with the provisions enshrined in the Mexican Official Standard (NOM) 220-SSA1-2016 to install and operate pharmacovigilance systems, as well as with the provisions established by the CNFV governing systems in compliance with international standards in this area. The notifications will be uploaded to the CNFV, evaluated and if the entity considers these to be successful, each company may immediately begin to use the channel to inform of any safety problems with the medicines. All parties involved in the pilot project must issue reports without exception by the deadline of May 2, 2020.

The Ministry of Health (SSA, for its acronym in Spanish) stated that it is working with national laboratories so that they can manufacture oncological drugs and boost the local supply and provision of medicines for cancer patients. The idea is for national laboratories to begin manufacturing these drugs as of March 15. The SSA clarified that this “will ensure the continuity of cancer treatments for the members of the population lacking social security.”