What is the Farmacopea De Los Estados Unidos Mexicanos?
The Farmacopea De Los Estados Unidos Mexicanos (FEUM) is the official document issued by the Secretariat of Health of Mexico that contains the general methods of analysis and the requirements on identity, purity and quality of drugs, additives, medicines, biological and biotechnological products. It is mandatory for the establishments that process these health inputs, according to the article 258 of the General Health Law.
Farmacopea De Los Estados Unidos Mexicanos.pdf
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The FEUM is updated periodically by the Commission of Pharmacopoeia of the United Mexican States (CPFEUM), which is composed of representatives from the government, academia, industry and professional associations. The CPFEUM also produces supplements and reference substances to complement the FEUM.
The FEUM aims to ensure that the health inputs are functional, effective and safe, according to the characteristics of the country. It also contributes to the harmonization of standards and regulations with other countries and international organizations.
The FEUM can be downloaded in PDF format from the official website of the CPFEUM[^1^] or from other online sources[^2^]. The current edition is the 13th, published in 2020.
The FEUM covers a wide range of topics related to the health inputs, such as general notices, general methods of analysis, monographs of drugs, additives, medicines, biological and biotechnological products, herbal medicines, homeopathic medicines and medical devices. It also includes appendices with tables, figures and formulas.
The FEUM is based on the best available scientific evidence and follows the international standards and recommendations of the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Pan American Network for Drug Regulatory Harmonization (PANDRH) and other relevant bodies.
The FEUM is a valuable tool for the health professionals, researchers, regulators, manufacturers and consumers who are involved or interested in the health inputs. It provides reliable and updated information that helps to ensure the quality, safety and efficacy of these products.
The FEUM is constantly updated and improved by the CPFEUM, which receives and evaluates proposals from different sources, such as the Secretariat of Health, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the National Institutes of Health, the National Council of Science and Technology (CONACYT), the academic institutions, the industry associations and the general public. The CPFEUM also organizes workshops, seminars and courses to disseminate and promote the use of the FEUM.
The FEUM is part of the legal framework that regulates the health inputs in Mexico, along with other laws, regulations, norms and agreements. The COFEPRIS is the authority responsible for enforcing the compliance with the FEUM and imposing sanctions in case of violations. The COFEPRIS also collaborates with other national and international agencies to monitor and control the quality, safety and efficacy of the health inputs.
The FEUM is a dynamic and evolving document that reflects the scientific and technological advances and the needs and expectations of the society. It is a source of reference and guidance for the development, production, evaluation and use of the health inputs in Mexico.