辟谣-海正药业警示函

上个月关于海正进口警示在医药界被传得沸沸扬扬，于是乎，我关注了一下FDA网站上的原文。
  其实海正此次事件时被FDA归类为进口禁令（Import Alert），这与警告信（Warning Letters）是两个不同的概念。可以到FDA警告信页面进行查询，并没有关于海正的警告：http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
  而进口禁令，在企业进行整顿并获得FDA检查的再次通过后，该进口禁令便可以解除。海正被FDA警示的问题，归属在警示编号#66-40下面，该警示的题目为：Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs，即由于制药公司有悖于GMP，所以可以不经检查直接扣留。此类禁令的发布，并不一定是由于FDA检查结果引起，也可以是参考互认国的检查结果或相关信息而发布。原文描述如下：


Reason for Alert:
*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.

DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***

Guidance:
*** Districts may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert.

Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA-s Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." Information supporting removal should be sent to CDER's Office of Compliance, (HFD-300).

自从海正药业被披露该消息后，业内不少撰稿人将海正作为反面教材书写在各种微文，发布在网络。但是都缺少一个公正客观的评价。纵观整个进口警示中中国企业，有几十家之多，其中也包括东北制药等大型药企。我看到的并不是大型药企的落魄，而是树大招风，以及业界普遍存在GMP问题的表现。在去年我们还在因为FDA大举拿获印度多家制药企业而扼腕叹息之时，殊不知这么快中国也将步其后尘。这是一个机会与挑战并存的时代，冲在前面的风险最大，但也最了解这个时代。

需要学习楼主这样的科学态度，尤其从事药品相关的工作，更应严谨，不能人云亦云。