The Mexican Pharmacopeia (FEUM) As Standard Of

The Mexican Pharmacopeia(FEUM) as standard ofpharmaceutical productsRafael Hernández MedinaRío Rhin 57, col. Cuauhtémoc.C.P. 06500, Ciudad de México. 52 55 5207-8187 5207-6887 ext. mx

Pharmacopoeias in the worldThere are currently 192 countries participating in the WHO 45countries have a national pharmacopoeia

Farmacopea MexicanaAcademia Farmacéutica de laCapital de la República184618741884Nueva Farmacopea ionSixtheditionFiftheditionOficialFarmacopea Nacional de los Estados Unidos dedition1974Fourthedition

Since 1984 it was defined a new structureto allow a quick and timely updateFarmacopea de los Estados Unidos Mexicanos1988FiftheditionMexican nPharmaciesSupplementMedical 12014TentheditionEleventheditionSupplement2016

Pharmacopoeia referred to in national legislationsMexican Pharmacopoeia is referred in national legislation: General Law of Health (LGS): It states that drugs and other healthproducts are regulated by the Mexican Pharmacopoeia; Articles 195,200, 224, 258 and 370. Regulation of Health Supplies (RIS), articles on the 2nd, 7th, 8th, 13th,17th,21st, 75th and 167th. Mexican Official Standards: Mexican Official Standard NOM-001-SSA12010, which establishes the procedure by which is reviewed,updated and edited the Pharmacopoeia of the United Mexican States.The Mexican pharmacopoeia is also referred to other Mexican standards.

DefinitionThe document is issued by theMinistry of Health to establishthe general methods ofanalysis and the requirementsfor identity, purity and qualityof drugs, additives, medicines,biologicals and other healthsupplies.

National legislation includes reference to other. Regulation of Health Supplies in Mexico states that:The quality specifications of medicineadditives, drugs and medicines are those indicatedin the current edition of the MexicanPharmacopoeia. When it does not contain theinformation, the pharmacopoeias of othercountries may be used (Or other internationallyrecognized scientific literature.)

FEUM as mandatory documentArticles 200 and 258 of GeneralLaw of Health indicated wichestablishments require possess,use and be implemented thelatest edition of the FEUM andits supplements.

Administrative sanctions by LGSNot possess or not go intoeffect the latest edition of theFEUM and its supplements, Itentails a fine of 6,000 to12,000 times the dailyminimum wage, according toart. 421 of the LGS.

Regulation of Health SuppliesIn order to get the healthregistration for medicines it requirethat specifications for identity andpurity is consistent are as indicatedin FEUMArt. 167, 173, 174 y 178 of RIS. DOF 04/feb/1998

CPFEUMAssessor bodyBoard of DirectorsExecutive DirectorMINISTRY OFHEALTHCOFEPRIS*Pharmacopoeia &PharmacovigilanceExecutive DirectorTechnical CouncilMEXICAN FARMACOPEEIAASOCIATIONExecutive DirectorTechnical and financial support* Federal Commission for Protection against Health Risks11

CollaboratorsGovernment39%Industry 24%Universities37%

Technical councilTechnical council divided in 24 committeesintegrated by 215 professionals.13

Mexican Pharmacopoeia, 11th Edition (2014)(Annual Update)Mexican Pharmacopoeia, 11th Edition (2014) .(Annual Update). 138 General methods of analysis.178 Monographs of additives.527 Drug monographs.662 Monographs for Medicines.7 Monographs of medical gases.39 Monographs of biological products.64 Biological product methods.11 Monographs of biotechnological products.27 Monographs of hemoderivative products.16 Monographs of dissolution profiles, among other chapters.10 Critic Systems monographs.45 Radiopharmaceuticals monographs.73 Basic Tests for drugs.13 Bioequivalence Guide for studies.

Reference Substances Reference substances are high puritymaterials without impurities and excipients.Those are stored in adequate conditions todecrease the degradation kinetic activity. Reference substances are established withapproval from Reference substanceCommittee from Mexican PharmacopoeiaPermanent Commission and following theirrecommendations. Those are used in identity physic-chemicaltests and essays explained in the monographsfrom Mexican Pharmacopoeia and supplies. Currently, the Mexican Pharmacopoeia has aprogram of work for the establishment ofpharmaceutical reference substances.

International collaborationand harmonizationCollaboration with and/or being part of a (different) national/regionalpharmacopoeia. The Mexican pharmacopoeia has signed a collaboration agreement withUSP.Publication of harmonized pharmacopoeia texts within thepharmacopoeia.Collaboration with World Health Organization. Good pharmacopoeial practices

Interaction with stakeholders, including regulators Although FEUM has always had into account the opinions ofits users. Since 2005 it has been established a procedurethat allows greater interaction with users and othersinterested in its contents. We have four periods per year of consultation through awebsite open to the public: www.farmacopea.org.mx When it’s necessary, we develop forums in order to discussspecific topics.

Goals for FEUMIncrease the monographs considering the followingpriorities: Cover the basic tables and catalogue of consumablesused in the health sector in Mexico Include the generic list biotechnological products

Thanks!Río Rhin 57, col. Cuauhtémoc.C.P. 06500, Ciudad de México.Rafael Hernández Medina 52 55 5207-8187 5207-6887 ext. mx19

International collaboration and harmonization Collaboration with and/or being part of a (different) national/regional pharmacopoeia. The Mexican pharmacopoeia has signed a collaboration agreement with USP. Publication of harmonized pharmacopoeia texts within the pharmacopoei