Medical network - February 20 state drug supervision administration designated 2017 six drug regulatory focus on work!
Recently, the national drug regulatory work conference held in Beijing.
Seriously implement the national food and drug supervision and administration and the party's style of work and the commendation advanced meeting to build a clean government work conference spirit, comprehensive summarize 2016 drug regulatory work situation, deployed in 2017, the key work.
Wu zhen, deputy chief of the state food and drug supervision and administration bureau to attend the meeting and delivered a speech.
Conference pointed out that over the past year, the national drug regulatory front advance drug regulatory work, has made remarkable achievements. Adhere to the problem oriented, rectification prominent question, deployed to carry out the production field of drug circulation, illegal conduct rectification, to further standardize the production and operation order.
Initiate an investigation in the field of circulation enterprises 1383, revocation of the pharmaceutical trade license, 40, the cancellation of the pharmaceutical trade license of 207, revocation of drug GSP certificate, 172, 47 cases transferred to public security organs.
Take medicine GMP certificate of eight production enterprises, 2 cases transferred to public security organs.
Adhere to the risk control, eliminate safety hidden trouble in time.
Continuously improve drug inspection, testing, monitoring methods, organization to carry out the flight check, track, check, check and tracking audit abroad, special supervision to sample, pay attention to the adverse drug reaction monitoring, efforts to the hidden danger, risk control, to ensure public safety.
Adhere to in accordance with the law regulation at the same time, to strengthen the construction of supervision system, adhere to the information publicity, increase the intensity of exposure.
Efforts to improve ability, strengthen supervision team construction, administration, and employ a total of 649 national drug inspectors, carried out and check.
Wu, drug regulatory agencies at all levels should have risk awareness, identify drug regulatory facing the new situation, new tasks and new requirements.
Drug safety is public security issues and political and security issues, to do a good job of drug regulatory is major political task, must focus on risk management, and resolutely implement the "four most strict" requirement, strengthen the source defend and process to find risk monitoring control, increase the intensity of punishment, trying to make supervision work is always running in front of the risk.
Wu stressed that 2017 should be practical to do a good job of drug regulatory mainly from six aspects:
1. To focus on outstanding problems in regulation
In pharmaceutical production link, we will continue to do a multicomponent biochemical medicine, Chinese medicine extract, rubber products renovation work, emphasis is investigated and the fight against the change process without authorization, illegally added in the process of production, data fraud and other illegal behavior, the data cannot be traced, unreal to serious processing.
Wholesale in circulation link, the key to crack down on unlicensed operation and attached ticket, zhang ticket goods inconsistent, such outstanding problems as data fraud, across the country to carry out the urban and rural copula and rural small pharmacies, clinics and drug quality control, the traditional Chinese medicinal materials professional market and the surrounding yinpian enterprise keep high pressure situation.
2. The formation and to improve drug safety risk analysis system
To strengthen the exchanges of information sharing and discovery, risk assessment, risk, risk management and risk communication mechanism.
Provincial bureau to be listed on the new varieties will check before 3 years, a new start, vaccines and blood products production enterprises, is reported to have happened enterprise, clustering quality problems such as adverse reaction and sampling observation unqualified enterprises must check and found that the problem must be timely treatment.
3. The integration of the national drug inspection resources, improve the sampling targeting, timeliness and service efficiency of funds, to form the national game, improve the efficiency of finding problems.
Across to the jurisdiction products as the focus of the sampling. , strengthen the unqualified product disposal and the packages of unqualified drugs in the first place temporarily control products, shelves and recall discontinuation.
Enterprise of producing unqualified products processing, and processing result in public. Public sampling observation information in time, improve the enterprise self-discipline.
4. Administration of leading the investigation case, auditing and supervision at the same time to participate in, the check records and evidence gathering together, combine to conduct checks and investigations. Pharmaceutical producing enterprises JiaLie drug cases dealt with directly by ShengJu.
Agency designated by the ShengJu should investigate case, cannot be layers of handover. Increase the cohesion and criminal justice, responsibility to the people. Strengthen the illegal cases exposure.
5. Try to build a reliable political honesty and uprightness, and exquisite business, a fine style of drug inspector team, 2017 key construction drug GSP inspectors and vaccine inspector team of blood products. Inspector training examination and inspection tasks to complete appraisal system.
6. To continue to implement the party's style of the cultivation of clean government responsibility, regulators must firmly against this alert, curb abuses and corruption.
Leading cadres to implement the integrity, responsibility, regulation and principle of integrity, to build strong and solid defense against corruption.
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