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NOM-257-SSA1-2014, In matters of biotechnological drug products.



Published in the Official Daily of the Federation December 11, 2014 – Effective February 09, 2015




This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health

LAW, REGULATION, OR NOM - what is the difference?  


NOM-257-SSA1-2014, En materia de medicamentos biotecnológicos. NOM-257-SSA1-2014, In matters of biotechnological drug products.




0.         Introducción.

0.         Introduction

1.         Objetivo.

1.         Objective

2.         Campo de aplicación.

2.         Field of application.

3.         Referencias.

3.         References.

4.         Símbolos y abreviaturas.

4.         Symbols and abbreviations.

5.         Directrices generales de operación para la evaluación de la información técnica y científica presentada durante el proceso de la solicitud de registro de medicamentos biotecnológicos.

5.         General directives of operation for the evaluation of the technical and scientific information presented during the processing of the application for the registration of biotechnological drug products.

6.         Control de la fabricación de medicamentos biotecnológicos.

6.         Control of the manufacturing of biotechnological drug products.

7.         Autorización de protocolos.

7.         Authorization of protocols.

8.         Farmacovigilancia de medicamentos biotecnológicos.

8.         Pharmacovigilance of biotechnological drug products.

9.         Requisitos para el reconocimiento de medicamentos biotecnológicos de referencia.

9.         Requirements for the recognition of biotechnological drug products of reference.

10.       Estudios de biocomparabilidad de medicamentos biotecnológicos.

10.       Studies of bio-comparability of biotechnological drug products.

11.       Concordancia con normas internacionales y mexicanas.

11.       Concordance with international and Mexican standards.

12.       Bibliografía.

12.       Bibliography.

13.       Observancia de la Norma.

13.       Observance of the standard.

14.       Vigencia.

14.       Validity

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