RDPAC药品推广行为准则 - IFPMA
RDPAC药品推广行为准则 - IFPMA
RDPAC药品推广行为准则 - IFPMA
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第三条 药品获得上市许可<br />
之前的信息交流及在药品标<br />
明的适用范围之外使用药品<br />
会员公司在其药品获得中国<br />
药品主管部门颁发的上市(生产<br />
或进口)许可之前,不得从事为<br />
在中国上市使用该药品而进行的<br />
推广活动。<br />
上述规定并不影响科学界及公<br />
众对科学和医学发展动态的充分知<br />
情权。它既不限制对药品的科学信<br />
息作充分适当的沟通,包括通过专<br />
业的科学或大众媒体以及在专业的<br />
科学交流会议上公布有关药品的科<br />
研结果,也不限制应相关法律、法<br />
规、准则或规章的要求或号召向利<br />
益相关人士和其他人公开披露药品<br />
信息。<br />
注释9<br />
第四条 药品推广信息的标准<br />
4.1 药品信息的一致性<br />
药品信息推广应与中国药品主<br />
管部门批准的药品信息相一致。在<br />
Article 3 Pre-Approval<br />
Communications and<br />
Off-Label Use<br />
No pharmaceutical product shall be<br />
promoted for use in China until the requisite<br />
approval for marketing for such<br />
use has been given by the SFDA.<br />
This provision is not intended to prevent<br />
the right of the scientific community<br />
and the public to be fully informed<br />
concerning scientific and medical<br />
progress. It is not intended to restrict a<br />
full and proper exchange of scientific<br />
information concerning a pharmaceutical<br />
product, including appropriate dissemination<br />
of investigational findings<br />
in scientific or lay communications<br />
media and at scientific conferences.<br />
Nor should it restrict public disclosure<br />
of information to stockholders and<br />
others concerning any pharmaceutical<br />
product, as may be required or<br />
desirable under any applicable laws,<br />
regulations, codes, or rules.<br />
ANNOTATION 9<br />
Article 4 Standards of Promotional<br />
Information<br />
4.1 Consistency of Product Information<br />
Promotion should not be inconsistent<br />
19<br />
研<br />
制<br />
开<br />
发<br />
制<br />
药<br />
企<br />
业<br />
协<br />
会
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