GMP Certificate Faces Big Cleaning Drug Administration Undercover Visits at Any Time


Release time:

2015-01-23


Recently, the official website of the CFDA announced that it is called to strengthen the prevention and control of drug safety risks and investigate and deal with drug violations in accordance with the law. The General Administration organized the drafting of the "Drug Flight Inspection Measures (Draft)" (hereinafter referred to as the "Measures").
Meeting discussion focus
On January 7, 2015, the Department of Legal Affairs and the Department of Pharmaceutical and Pharmaceutical Supervision organized an expert seminar in Beijing, inviting the Supreme People's Court, Beijing Higher People's Court, Beijing No. 1 Intermediate People's Court, Beijing Municipal People's Congress Legal Affairs Office, China University of Political Science and Law, and Experts, scholars and legal advisers from Zhongzhao Law Firm discussed difficult issues in the draft regulations. The person in charge of the Legal Affairs Department, the Pharmaceutical Supervision Department, the Pharmaceutical Registration Department, the Inspection Bureau and the relevant staff of the Audit and Inspection Center attended the meeting.
The experts conducted in-depth discussions on the nature and positioning of unannounced inspections, the acquisition of law enforcement qualifications for inspectors, the conversion and use of evidence collected during inspections in administrative penalties, and the legality of unannounced visits. In addition, experts also put forward valuable opinions and suggestions on improving the operability of regulations, detailing the situation that enterprises do not cooperate with inspection, seriously dealing with the disciplinary violations of supervisors, and strengthening the authority of law enforcement.
The meeting opened up regulatory ideas, clarified difficult issues, and provided basic guarantees for legal and scientific legislation.
In 2014, the frequent scope of flight inspections and the continuous withdrawal of GMP certificates dazzled the industry. Although the flight inspections of national and provincial bureaus continued and the GMP certificates of pharmaceutical companies were continuously withdrawn, the industry, including pharmaceutical companies, began to feel numb.
In early 2015, the National Bureau held a seminar attended by legal professionals and heads of relevant departments and bureaus. What information did it reveal?
Pharmaceutical companies, are you ready to be interviewed at any time?
First of all, there is no doubt that flight inspection will play an increasingly important role in supervision this year and beyond. At the 26th National Pharmaceutical Economic Information Conference that ended in November 2014, Wu Liya of the Department of Legal Affairs made a report entitled "Introduction to the Revision of the Drug Administration Law", introducing the latest progress and overall progress of the revision of the Drug Administration Law. Thinking.
It is mentioned that in order to cope with the increasingly complex trend of drug supervision, the new Drug Administration Law plans to gradually decentralize and abolish the drug GMP and GSP certification systems, combine the certification system with the access standards of drug enterprises, as well as the supervision of daily production and operation behavior, reduce examination and approval supervision, and strengthen daily supervision and inspection. Flight inspection is one of the powerful measures. Supervision will become more and more stringent with the help of flight inspections.
Secondly, after flight inspections become more and more frequent and strict, under the premise of governing the country according to law, governing according to law is the most concerned topic of the drug regulatory department. Judging from the departments and bureaus participating in the symposium, the heads of the legal department, the pharmaceutical supervision department, the pharmaceutical registration department, the inspection bureau and the examination and inspection center cover the main departments of drug supervision. the discussion between these main supervision departments and the legal profession is obviously to discuss the inspection methods and the problems faced in the inspection with the legal profession to discuss the legality and compliance.
Among them, unannounced visits were highlighted at this symposium. It is foreseeable that after discussing the legality of unannounced visits, unannounced visits may become an important way of flying inspections. Pharmaceutical companies are you ready to be unannounced at any time?
Thirdly, judging from the combination of CFDA and judicial circles, in the future inspection, the national bureau and provincial bureau will not rule out joint law enforcement with public security, industry and commerce and other departments, and the punishment for violations of laws and regulations may be more serious in the future.
After the normalization and strictness of flight inspections, the estimated number of GMP certificates withdrawn from non-compliant pharmaceutical companies will increase. For a long time, the country has been hoping to change the current situation of small, scattered and chaotic pharmaceutical companies in China through GMP certification. However, although the new GMP certification in line with the EU has eliminated many pharmaceutical companies, judging from the number of pharmaceutical companies, it seems that there has not been much change. With such frequent flight inspections, has the industry been reshuffled?