ABSTRACT
OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.
ABSTRACT
A lo largo de la historia de México, la Homeopatía ha logrado construir un modelo de atención médica con características e identidad propia que forma parte de la medicina mexicana, y que desde su institucionalización está regulada por las leyes, los reglamentos y las normas que son aplicables a la profesión médica. No obstante lo anterior, existe un movimiento para crear una Norma Oficial Mexicana para la Práctica de la Homeopatía, olvidándose de que el médico homeópata está facultado para ejercer a través de su título y cédula profesional. En este artículo se hace una serie de planteamientos que tienen la intención de aportar elementos que lleven a un análisis reflexivo y serio en torno a los beneficios y las desventajas de una norma oficial mexicana, y evitar que se tomen decisiones que posteriormente afecten al médico homeópata en México...
Throughout its history in our country, homeopathy has built a model of health care with some characteristics and own identity as a part of Mexican medicine, and since its institutionalization is regulated by the laws, rules and standards applicable to the medical profession. Nevertheless, there is a movement to create a Mexican Official Standard for the Practice of Homeopathy, forgetting that the homeopathic physician is authorized to practice through its title and license. The central idea of this article is to provide elements, that lead to a serious and thoughtful analysis on the benefits and disadvantages of a mexican official standard and avoid decisions that affect the mexican homeopathic doctor to be taken...