【直报网1月26日讯】（生物探索）暗访药企或成飞行检查重要方式 医药行业大清洗在即 近日，CFDA官网发布消息称，称为强化药品安全风险防控，依法查处药品违法行为，总局组织起草了《药品飞行检查办法（草案）》（以下简称《办法》）。

CNDSN January 27th news  (biological exploration) unannounced visits to pharmaceutical companies or into flight check important way of pharmaceutical industry cleaning soon recently, CFDA's official news release, called for strengthening drug safety risk prevention and control, to investigate and deal with illegal drugs, Drug Administration organized the drafting of the "flight inspection methods (Draft)" (hereinafter referred to as the "way").

会议讨论重点

The meeting discussed the key

2015年1月7日，法制司会同药化监管司在京组织召开专家研讨会，邀请最高人民法院、北京市高级人民法院、北京市第一中级人民法院、北京市人大法制办、中国政法大学以及中兆律师事务所的专家、学者及法律顾问就规章草案中的难点问题进行研讨。法制司负责人、药化监管司、药化注册司、稽查局以及审核查验中心相关工作人员参加了会议。

In January 7, 2015, legal affairs department, in conjunction with the drug supervision department organization expert seminar held in Beijing, invited the Supreme People's court, the Supreme People's Court of Beijing, the Beijing first intermediate people's court, Beijing Municipal People's Congress law office, China University of Political Science and Law and trillion in lawyer office of experts, scholars and legal adviser on the difficult problems in the draft regulations were discussed. Legal affairs department, responsible person, drug supervision department, drug registration department, Inspection Bureau and inspection center related personnel attended the meeting.

专家们就飞行检查的性质与定位、检查人员执法资格的获得、检查过程中收集的证据在行政处罚中的转换与使用、暗访的合法性等问题进行了深入的讨论。此外，专家还针对提高规章的可操作性、细化企业不配合检查的情形、严肃处理监管人员的违纪行为、加强执法的权威性等提出了宝贵的意见与建议。

Legal issues the experts on the nature and orientation, flight check law enforcement personnel qualifications obtained in the examination process, collect the evidence conversion in administrative punishment and use, make unannounced visits is deeply discussed. In addition, the experts also aimed at improving regulations operability, refining enterprises do not coordinate with the inspection situation, discipline behavior, serious processing regulators put forward valuable opinions and suggestions to strengthen law enforcement authority etc..

此次会议开拓了监管思路，厘清了疑难问题，为依法立法、科学立法提供了基本保障。

The meeting opened up the idea of supervision, to clarify the knotty problems, provides a basic guarantee for the legislation, scientific legislation.

2014年，飞行检查频频范围，不断收回GMP证书的消息让业内眼花缭乱，虽然国家局和省局的飞行检查还在继续，还有药企的GMP证书不断被收回，但是业内包括药企都开始麻木了。

In 2014, flight check frequently range, continue to recover the GMP certificate message let the industry see things in a blur, although flight check in the National Bureau and the Provincial Bureau continues, and pharmaceutical companies continue to be recovered GMP certificate, but the industry including pharmaceutical companies have begun to numb.

而2015年年初，国家局召开由法律界人士和相关司局负责人参加的研讨会又透露出了什么信息呢？

In early 2015, the National Bureau held by the legal profession and related departments in charge of people to participate in the seminar also revealed what information?

药企，做好随时被暗访的准备了吗？

Pharmaceutical companies, make unannounced visits at any time be ready?

首先，毋庸置疑的一点是，飞行检查在今年乃至以后的监管中将发挥越来越重要的作用。2014年11月结束的第26届全国医药经济信息发布会上，法制司的吴莉雅做了题为《药品管理法修订情况介绍》的报告，介绍了《药品管理法》修订情况的最新进展和整体思路。

First of all, there is no doubt a bit, play a more and more important role in flight check this year and subsequent regulation. In 2014 November the end of the twenty-sixth session of national medicine economic information conference, legal secretary Wu Liya made entitled "Introduction" drug administration law revision of the report, introduces the latest progress and the overall train of thought of "Drug Administration Law" revision of the.

其中提到，为了应对日益复杂的药品监管趋势，新《药品管理法》拟逐步下放和取消药品GMP和GSP认证制度，将认证制度和药品企业准入标准，以及日常生产、经营行为的监管结合起来，减少审批监管，加强日常监督检查力度。飞行检查，就是这些措施中的有力之一。监管将借助飞行检查越来越严格。

One mentioned, in order to drug regulatory trends to cope with the increasingly complex, the new "Drug Administration Law" quasi gradual decentralization and cancel the drug GMP and GSP certification system, the certification system and medicine enterprises access standards, and daily production, management behavior supervision combined, reduce examination and approval supervision, strengthen the daily supervision and inspection efforts. Flight inspection, is a powerful one of these measures in the. With the help of flight inspection supervision will be more and more strict.

其次，飞行检查越来越频繁、严格后，在依法治国的前提下，依法执政是药监部门最为关注的话题。从参加参加座谈会的司局来看，法制司负责人、药化监管司、药化注册司、稽查局以及审核查验中心，涵盖了药品监管的主要部门，把这些监管主要部门和法律界人士共同座谈，显然是将稽查办法以及稽查中面临问题和法律界人士研讨，探讨合法性、合规性。

Secondly, flight inspection is more and more frequent, strictly, on the premise of law, ruling according to law is the most concerned topic for the drug administration department. From participating in attending the forum departments, legal affairs department, responsible person, drug supervision department, drug registration department, Inspection Bureau and inspection center, covering the main Department of drug supervision, put these supervision department and legal professionals Joint Forum, apparently and protracted problems and legal professionals face method research and inspection, investigate the legality, compliance.

其中，暗访是在此次座谈会上被重点点出的内容，可以预见的是，经过对暗访合法性的探讨后，暗访或许成为飞检的重要方式，药企你做好随时被暗访的准备了吗？

Among them, make unannounced visits is at the forum was the key point of the content, it is foreseeable, after a discussion on the legitimacy of the town after town, may become an important way to fly check, pharmaceutical companies you do were visits at any time to prepare?

再次，从此次CFDA和司法界人士的联合来看，未来国家局和省局在未来的检查中，不排除和公安、工商等部门联合执法，违法、违规行为在将来收到惩罚或许更加严重。

Once again, from the combined the CFDA and judicial circles, the future National Bureau and the Provincial Bureau of inspection in the future, do not rule out the public security, industry and commerce departments and joint law enforcement, illegal, illegal behavior in the future may be more severely punished.

飞行检查常态化、严格化之后，不合规范的药企被收回GMP证书的估计数量还会增加。长久以来，国家一直希望寄希望于通过GMP认证等方式改变目前中国药企小、散、乱的局面，但是和欧盟接轨的新版GMP认证虽然淘汰了很多药企，但是从药企数量来看，似乎并无太多改变，这么频繁飞检，行业大洗牌到了吗？▲

After the flight check normalization, strict, not estimated amount will GMP certificate was recovered standard pharmaceutical companies increase. For a long time, the country has been hopes for certification through the GMP way to change the current Chinese pharmaceutical companies small, scattered, chaotic situation, but the new version of GMP certification and the EU standards although eliminated many pharmaceutical companies, but from pharmaceutical companies in terms of the number, does not seem too much change, so frequent flying inspection, industry wide reshuffle to do? *

（原标题：暗访药企或成飞行检查重要方式 医药行业大清洗在即）

(original title: investigations into pharmaceutical or flight check important way of pharmaceutical industry cleaning around the corner)

责任编辑：小申

Editor: small Shen