In February 2016, Mexico updated its regulations 059 and 164 regarding the Good Manufacturing Practices (GMP) of drugs and active pharmaceutical products with the goal of joining the Pharmaceutical Inspection Cooperation Scheme (PICS).
The GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The PICS is an international instrument between countries and pharmaceutical inspection authorities to support the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
The Mexican Health Authority (COFEPRIS) plans to join PICS later in 2016, after amendment of its GMP regulations and the evaluation of its quality management system by experts from Spain, Italy, U.S.A. and Germany.
The inclusion of Mexico to the PICS program will strengthen its international cooperation mechanisms regarding inspections, promote the exchange of information and implement the best international practices for the manufacture of pharmaceutical products.
The Argentinian National Administration of Drugs, Foods and Medical Devices (ANMAT) is the only Latin American health authority that is currently part of PICS.
Source: http://www.cofepris.gob.mx
Previously published on 15 March 2016
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