March 17, 2010 in Beijing Drug Administration meeting in Beijing. Party secretary of Beijing Municipal Food and Drug Administration, the Secretary Cong Luo Luo said at the meeting: "'Eleventh Five-Year Plan' period, the level of capital, significantly improve drug safety, drug safety performance evident.
2011 is the 'second five' first year, the Beijing Municipal Food and Drug Administration will follow 'strict access, scientific supervision, investigate and punish, the area responsible' approach, digital thermometer establish drug safety 'great service' concept, to build 'with the capital level, to adapt to the capital development, and service people in the capital 'of the drug regulatory system, to promote the' second five 'plan a good start, clinical thermometer enhance international and modern standards. "
According to report, in 2011, the Beijing Municipal Food and Drug Administration will establish a "great service" concept, start drug safety public service. Year will complete the "Three Grades of a mechanical" quality sampling 12,000, medicines, medical equipment, health food, cosmetics testing pass rates were stable at 98%, 90%, 95%, 95%; the basic coverage of adverse drug reaction monitoring , ear thermometer the basic varieties of electronic monitoring of drug coverage to 100%.
During the years of service in drug safety, the Beijing Food and Drug Administration will start building the "two platforms," ??Beijing is safe emergency command a comprehensive platform to integrate existing information systems to enhance the level of command and coordination of emergency response and information delivery capabilities. The other is the Beijing platform for drug safety, public service, digital blood pressure monitor to create a stand-alone public service website providing drug safety information for the public inquiry, publishing, consulting, expert microblogging services, raise public awareness of "Three Grades of a mechanical" products ability to distinguish the authenticity of regular information to the community and risk of drug safety alerts.
Strengthen the supervision of essential medicines.
Deepening medical reform in 2011 was to wrap up the recent focus on the task, and also tackling the years, the better the quality and safety of essential drugs off the work of this year the focus of Beijing Drug Administration.
This year, the Beijing Municipal Food and Drug Administration will strengthen the production and circulation control, centralized procurement of essential medicines must comply with winning new national standard, and equipped with electronic monitoring code, and thus improve product access threshold; take the lead in promoting and monitoring the production enterprises to develop new essential drugs GMP Certification , the phasing out of the business not up to standard.
At the same time, deepen the wide variety of electronic monitoring of essential drugs covered, complete manufacturer of electronic monitoring of essential drugs work, the implementation of electronic monitoring of essential drugs wholesale business to write off the nuclear injection, to achieve basic drugs from production to distribution of the whole process back. Deepen the quality and safety supervision of essential medicines cover all varieties of deepening the coverage of all essential drugs testing and full coverage of monitoring adverse events, improving the basic drug safety warning and emergency response mechanisms.
By deepening the coverage of the daily supervision of all aspects of the establishment of basic drug production, distribution and use of part of the normal mechanisms of supervision and inspection on the area of ??supervision and inspection of production enterprises not less than 2 times per year, on-site inspection and distribution companies of not less than 4 times a year to complete essential drug prescriptions and process verification, and further improve the basic drug safety responsibility system, strengthen supervision and law enforcement.
Actively promote innovation and regulation of essential drugs, essential drugs listed species to carry out safety assessment, a scientific and effective mechanisms for drug safety assessment.
Improve the regulatory model.
To improve the regulatory capacity, the Beijing Food and Drug Administration will improve the traceability system drug production, particularly drug supervision network, and actively promote the regulation of electronic medical preparations.
The quality system, and the implementation of corporate legal person, the quality of attorney, key position responsibilities and the presence of monitors quality and safety regulatory responsibility. In the inspection system, relying on the production of enterprise risk management system that will track the inspection, the flight inspection, special inspection of the combination.
In key species, and will be strictly special drugs, vaccines, biological products regulation, carried out special rectification of Chinese Herbal Medicine.