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Mexico Amends Good Manufacturing Practices for Drugs

The Mexican government on 22 July 2013 issued final technical regulations establishing new mandatory good manufacturing practices for medicaments with therapeutic, preventive or rehabilitating effects (NOM-059-SSA1-2013). The regulation includes requirements in such areas as documentation, quality management systems, personnel, facilities and equipment, validation and qualification, production systems, returns, release of finished products, quality controls, product recalls, subcontractors and final destination of residues. These technical requirements entered into force on 18 January 2014, although the provisions related to biologic and biotechnology products have been in effect since 16 September 2013.

Mexico also has in place separate mandatory GMPs for pharmaceuticals. Issued in June 2013, NOM-164-SSA1-2013 establishes minimum requirements for the production of pharmaceuticals and active principles commercialised in Mexico, including in such areas as documentation and related practices, quality management systems, personnel, facilities and equipment, validation and qualification, production systems, quality control laboratories, subcontractors, distributors, product recalls, pharmaceuticals for use in clinical studies, compliance with international and Mexican standards, and enforcement.

Mexican authorities recently adopted a number of changes to these technical regulations in an effort to harmonise them with Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. Once the amendments enter into force 2-3 August 2016 in the form of new standards NOM-059-SSA1-2015 and NOM-164-SSA1-2015, Mexico will ostensibly be able to accede to the Pharmaceutical Inspection Convention, which currently includes 46 members including the Food and Drug Administration, Health Canada, the Japanese Ministry of Health, Labour and Welfare, the Korean Ministry of Food and Drug Safety and numerous health agencies in Europe. Press reports indicate that one of the benefits of Mexico’s eventual accession to the PIC would be the possibility to negotiate mutual recognition agreements with PIC member countries. The amendments are also expected to enhance overall quality standards in the production and distribution of medicaments, pharmaceuticals and active principles in a harmonised regulatory environment.

In related news, Mexico also recently amended its GMPs for medical device manufacturing facilities (NOM-241-SSA1-2012) in an effort to ensure the correct application of GMPs for radiopharmaceuticals and contrast media.

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