CFDA regulatory model or change in 2015

Source: zhulikou431 2014-11-21 drug administration law is the basic law of China's drug regulation, which was adopted at the seventh meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and revised at the 20th meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001 At the beginning of 2014, CFDA launched a revised version of the drug administration law to solicit suggestions from the community; this can be seen as the driving force and starting point for the national drug regulatory agencies to seek for changes in regulatory thinking At the 26th national pharmaceutical economic information conference, which ended in November 2014, Wu Liya of the legal department made a report entitled introduction to the revision of the drug administration law, introducing the latest progress and overall thinking of the revision of the drug administration law It is mentioned that in order to cope with the increasingly complex trend of drug supervision, the new drug administration law plans to establish the following supervision ideas: gradually decentralize and cancel the GMP and GSP certification system, combine the certification system with the access standards of drug enterprises, as well as the supervision of daily production and operation behaviors, reduce the examination and approval supervision, and strengthen the daily supervision and inspection Flight inspection is one of the powerful measures In order to solve the conflict between the lower law and the upper law, the regulation of recall system is added to the drug administration law First, establish a double punishment system, take joint and several punishment measures for the enterprise legal person and quality authorized person (natural person), and establish a blacklist and exclusion system Second, increase the appointment and warning letter system In the current transitional stage, in order to ensure the stability, safety and reliability of the drug quality, CFDA has recently sent several flight inspection teams to carry out flight inspection on relevant enterprises At the same time, the State Administration also urged relevant provincial bureaus to send more manpower to carry out large-scale spot check and follow-up inspection on enterprises within their jurisdiction For example, on October 23, 2014, the State Food and Drug Administration (CFDA) issued a notice on flight inspection, investigating and punishing Changchun Yuanda Guoao Pharmaceutical Co., Ltd., Shaanxi momeide Pharmaceutical Co., Ltd and Zhejiang Qianjiang (Qiaocheng) traditional Chinese medicine Yinpian Co., Ltd respectively From the information disclosed in the CFDA notice, the problems these enterprises have committed are not general technical violations, but related to violations, which are very serious in nature Since November, the flight inspection intensity and density of CFDA are greater, and the regulatory trend is more severe According to the relevant information published on CFDA website and Provincial Bureau website, the flight inspection situation in 2014 is summarized as follows: in addition, according to reliable information, at least 7 domestic enterprises have accepted the inspection and inspection of National Bureau according to the mode of on-site inspection combined with GMP certification combined inspection This new mode is similar to the foreign inspection mode, that is, instead of multiple inspections by an enterprise, one inspection is carried out in the product registration stage After the enterprises accept the inspection and GMP certification inspection, once the approval number is obtained, they do not need to accept GMP certification inspection, but directly obtain GMP certificate From the perspective of the above changes in regulatory methods, CFDA tries to change the previous regulatory mode in combination with the revision of the drug administration law, replacing the previous management mode of emphasizing examination and approval with a high-intensity and effective daily regulatory mode.