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新闻来源:小编 | 发布时间:2019-10-30 17:45:16

GMP, GSP certification or suspension of the retention list

  On September 17, the official website of the state food and drug administration published the comprehensive department of the state food and drug administration to solicit opinions on the "> opinions on the list of existing certification items in the drug regulatory system (draft for opinions)" (hereinafter referred to as "opinions", the full text is attached), specifying the name, purpose and setting basis of the certification items to be retained one by one. September 17 - September 26, concerned units and individuals can give feedback.


药品GMP、GSP认证或暂缓取消 列入保留目录(图1)

  GMP, GSP or deferred cancellation

  According to the deployment of the State Council and the requirements of relevant documents issued by the Ministry of Justice, the state food and drug administration (sfda) has intensified efforts to streamline the list after soliciting opinions from relevant parties in the early stage, according to the opinions of the State Council and the Ministry of Justice. According to the catalogue, 105 certification items, including business license, drug production license, drug distribution license, certificate of drug production quality management standard, certificate of drug distribution quality management standard, and inspection report, are to be retained. Industry insiders said that once the draft for comment, it means that GMP, GSP suspension. To put it bluntly, GMP and GSP certificates will continue to be issued as separate administrative ACTS.

  Why is it included in the reservation list

  Some people may ask, regarding GMP, GSP certification, the newly revised "national drug administration law" has deleted the relevant description, so why does it appear in the proposed retention list?

  First, the opinions: the scope of the clearance of certification items is limited to the certification items that the administrative counterpart needs to provide in the process of handling administrative license, administrative confirmation and administrative payment, if clearly specified in the regulations and normative documents of the drug regulatory department. In accordance with the "four strictest" requirements, it is necessary to include in the catalogue the certification items concerning the safety of drug use by the public in the process of administrative licensing, administrative confirmation and administrative payment.

  Obviously, GMP and GSP play an important role in administrative management, and the conditions for cancellation are not sufficient. In the following period of time, keeping GMP and GSP is conducive to the supervision of government departments on the industry.

  The directory is dynamically managed

  Of course, the original intention of the state is to clean up and streamline administrative matters and relieve pressure on the industry. Then, with the continuous improvement of the legal system and the level of information, timely adjustment of the certification matters.

  According to the guidelines, local governments are encouraged to carry out trials first, and drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government can gradually cancel relevant certification items on their own, based on their actual conditions. That is to say, the retention is not fixed, but dynamic management, GMP, GSP certification and cancellation of the possibility.

  Nevertheless, whether GSP, GMP attestation is cancelled or not, aggrandizement is on the board after listing superintendence already is clinched. The newly revised drug administration law clearly states that this law shall apply to activities of drug research, production, marketing, use, supervision and management. In the research, production, marketing and use of drugs, laws, regulations, standards and norms shall be observed, and the whole process data shall be authentic, accurate, complete and traceable. This means that the new law is intended to regulate behavior rather than focus on the main body, and that all activities around drugs should be in continuous compliance, and flight inspections will become the norm.

  In the industry point of view, the general first battalion, electronic data exchange 001 platform to achieve the first battalion of the online transfer, full marks the traceability, huge amounts of data and permanent storage, can effectively solve the paper first camp data exchange time is long, easy to loss, radish chapter counterfeiting and other practical problems, help the pharmaceutical industry efficiency improvement, accelerate the process of intelligent push regulators.

  Although the new law USES 171 "shoulds", 32 "can" and none of them "must", the country's attitude is to ensure the safety, effectiveness and availability of drugs, as seen from the significantly increased punishment for illegal ACTS and related personnel.