RDPAC药品推广行为准则 - IFPMA

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研制开发制药企业协会遵守药品信息推广应与中国药品主管部门批准的药品信息相一致的要求同时,中国的医疗卫生专业人士应及时获得在世界其他国家传播的药品信息。 20 注释10 4.2 准确和不误导推广信息应当清楚、易理解、准确、客观、公正、和高度完整, 足以使受众能就有关药品的治疗价值形成自己的观点。药品推广信息应以对所有相关证据所作的最新评估为依据,并清楚地记载相关证据事实。推广信息不应通过曲解、夸大、过分强调、忽视、或其他方式误导相对人。推广者应尽最大努力避免使推广信息出现内容上的模糊不清。在给出绝对的和无所不包的论断时应十分谨慎,其必须以充分的论证和实证为基础。一般应避免使用诸如“安全”、“无副作用” 之类的描述性用语,如需使用也须有充分的科学论证。注释11 with pharmaceutical product information approved by SFDA. Respecting the requirement that promotion should be consistent with the label and approved uses by the SFDA, Chinese healthcare professionals should have access to similar data to those being authorized for communication in other countries of the world. ANNOTATION 10 4.2 Accurate and Not Misleading Promotional information should be clear, legible, accurate, balanced, fair, and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. Every effort should be made to avoid ambiguity. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. Descriptions such as ‘safe’ and ‘no side effects’ should generally be avoided and should always be adequately qualified. ANNOTATION 11
4.3 实证药品推广信息应能通过对已经批准的药品说明书或科学证据的引用而得到证实。当医疗卫生专业人士要求提供上述实证资料时,推广者应向其提供。会员公司应客观对待要求获取有关药品信息的善意请求,并应根据不同查询者的具体情况提供充分和适当的药品信息。注释12 第五条印刷推广材料在遵守中国法律、法规各项规定的前提下,所有印刷推广材料均须清晰易懂,并包括以下必备内容: (a) 药品名称(通常为药品的商品名); (b) 药物活性成份(应尽可能地使用经批准的名称); (c) 制药公司或药品代理公司的名称及地址; (d) 推广材料制作的日期; (e) 处方信息概要,包括已经批准的一项或多项适应症、用法用量,以及对禁 4.3 Substantiation Promotion should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry. ANNOTATION 12 Article 5 Printed Promotional Materials Subject to additional requirements under the Chinese laws and regulations, all printed promotional materials must be legible and include: (a) the name of the product (normally the brand name); (b) the active ingredients, using approved names where they exist; (c) the name and address of the pharmaceutical company or its agent responsible for marketing the product; (d) date of production of the material; (e) “abbreviated prescribing information” which should include an approved indication or indications for use together with the dosage and method of use; and a suc- 21 研制开发制药企业协会
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RDPAC药品推广行为准则 - IFPMA

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