Business News Agency August 7th: Wu Jian, Li Jiping, and Bian Zhenjia, Deputy Directors of SFDA, respectively deployed the key work in the second half of the year at the national food and drug supervision work conference.

The reform of the food and drug regulatory system, the supervision of essential drug quality, the formulation of the “Twelfth Five-Year Plan”, the reform of special projects, and the key tasks of overall development, will formally enter the critical stage of implementation in the second half of this year.

At the 2010 national food and drug supervision and management symposium held on August 1-3, in order to further emphasize the above-mentioned key work, the Deputy Director in charge of the State Food and Drug Administration (SFDA) has deployed several key tasks. Clear the task.

Wu Yan: Classification, batch, step-by-step implementation of drug electronic supervision

"As of the end of July 2010, the drug electronic regulatory network was operating normally. The nation's food and drug regulatory authorities and related drug production and wholesale companies all entered the network according to regulations. In July 2010, the average number of nuclear-injection verification and verification codes was approximately 12 million per day. "The deputy director of the SFDA Wu Hao said.

It is reported that as of the end of July 2010, food and drug regulatory authorities at all levels issued a total of 5257 key (digital certificates), 23278 registrations from the supervision department, and more than 200 landing systems in 20 provinces (autonomous regions and municipalities). More provinces are Yunnan, Liaoning and Hubei. Drug manufacturers have entered the network 504, issued a total of 925 key. Among them, 302 companies have applied for supervision codes, and 293 companies have started to report production data online, involving a total of 1097 kinds of drugs. Drug wholesale companies have access to 9397 homes, issuing keys 12788.

According to reports, in accordance with the principle of "step-by-step implementation and steadily advancing," the entire system of the food and drug supervision and administration department is categorizing, batch-wise, and step-by-step the implementation of drug electronic supervision.

In the first phase of work, in accordance with the provisions of the “Administrative Regulations on Narcotic Drugs and Psychotropic Substances” implemented on November 1, 2005, the State Bureau started the construction of a special drug supervision network in 2006. It was basically completed in October 2007 and realized The dynamic monitoring of the entire process from production, circulation to storage of narcotic drugs and a class of psychoactive drugs. The national accession rate of drug-related production enterprises, operating companies and regulatory agencies reached 100%.

In the second phase of work, drawing on the successful experience of the construction of the first phase of the special drug regulatory network, the implementation of blood products, vaccines, Chinese medicine injections and second-class psychoactive drugs (collectively referred to as “four categories”) has been implemented since November 1, 2008. Electronic supervision, unincorporated network, and uniform identification of unused electronic drug monitoring codes may not be sold.

In the third period, in accordance with the requirements of the State Council's medical reform work, an important part of the establishment of a basic drug system is to conduct electronic surveillance of all types of essential drugs.

In order to implement the implementation of the State Council's 2010 reform of the medical reform work, and effectively do a good job in the electronic supervision of basic medicines, the State Bureau issued the “Circular on the Electronic Surveillance of Essential Medicines for All Varieties”, which clearly states: Where successful bidders produce essential pharmaceutical varieties, Before March 31st, 2011, they joined the electronic drug regulatory network. Starting April 1, 2011, all types of drugs that are listed in the basic drug list, unregistered drugs, and unlicensed drug electronic monitoring codes must not be involved in basic drug procurement. . The electronic supervision work of the unqualified basic drug list product manufacturers shall be completed step by step according to the deployment of the State Bureau.

The fourth phase of the work will gradually implement electronic supervision of all listed drugs on the basis of the first three phases.

Wu Hao said that in view of the existing problems in the current work, the next step will be to increase the strength of the State Bureau, supervise the promotion, focus on the training work, construction of demonstration sites, and technical support and services. The food and drug supervision departments at all levels must stand on the height of ensuring the smooth progress of medical reform and stand on the standpoint of safeguarding the safety of drug use among the general public. With a high sense of responsibility and mission, they must make full use of the electronic supervision of all types of essential drugs.

Li Jiping: "12th Five-Year Plan" for Food Safety is being compiled

The Twelfth Five-Year Plan for National Drug Safety led by the State Food and Drug Administration, and the Twelfth Five-Year Plan for Food Safety Supervision System led by the Office of the Food Safety Commission of the State Council have been listed in the national special planning directory. It will be issued after approval by the State Council.

It is reported that at present, the above two plans have completed the research on the planning background, planning index system, supervision and protection system and technical supervision system, and organized and trained provincial planning staff. They are commissioning professional research institutions to carry out the preparation work in parallel.

Li Jiping, deputy director of the SFDA, said that the next step is to make planning and preparation work a crucial stage, with the focus on ensuring a high level of planning and ensuring that food and drug supervision content is fully reflected in the national and local government's "12th Five-year Plan". The 12th Five-Year Plan for food and drug safety has become a national or provincial-level special plan.

To this end, Li Jiping proposed that we must grasp three aspects: First, we must attach great importance to it and go all out. Planning, as an important basis for government investment, has a direct bearing on system-wide funding guarantees for the next five years. We must be proactive and try our best to gain more understanding and support from governments at all levels, development and reform departments. The deployment of elite forces specializes in this work and concentrates on the preparation work. The second is to standardize procedures and speed up progress. It is necessary to strictly abide by the planning procedures and complete all the required actions as required, in particular, key opinions such as soliciting opinions, expert demonstration, and signing and reporting. Try to push forward the work that you can control and leave room for the follow-up. The National Drug Safety "Twelfth Five-Year Plan" strives to complete the first draft in October and is reported to relevant departments for approval in December. The third is to link up early to implement the project. In the preparation process, we must pay attention to the feasibility of construction projects, and simultaneously compile project feasibility reports and implementation plans, communicate and coordinate with development and reform departments as early as possible, implement key construction projects, start planning and approval as soon as possible, and shorten the application period.

“This year marks the end of the “Eleventh Five-Year Plan” period for infrastructure construction. The general requirement is to speed up the implementation speed on the premise of guaranteeing quality and standard management. At the same time, project management is strengthened to ensure the standardization and safety of the use of funds. Effectiveness." Li Jiping stressed.

It is reported that the National Bureau of the United Nations Development and Reform Commission will carry out inspections of local projects, and regard the implementation of project construction as an important basis for arranging the "Twelfth Five-Year Plan" investment.

Bibian B: In-depth promotion of food and drug special rectification

“This year is the third year of food and drug safety improvement. It is very important to carry out rectification work in depth,” said Fang Zhenjia, deputy director of SFDA.

According to reports, in accordance with the requirements set by the State Bureau at the beginning of the year, “Accelerate actions, rectify the situation, implement solid measures, and consolidate results”, in-depth reforms have been carried out around outstanding issues and weak links, and the working mechanism for departmental linkage and comprehensive governance is gradually deepening. Some deep-seated problems are being gradually solved, and the nationwide food and drug remediation work has achieved initial success.

Bi Zhenjia said that in the second half of the year, all localities must further raise their awareness of the work of rectification, take more effective and effective measures, and do their utmost to bring the rectification work to fruition and achieve results. In the second half of the year, it is necessary to pay close attention to implementation and ensure that all measures for rectification are implemented; strike out heavy blows and severely crack down on counterfeiting and counterfeiting; highlight key points and solidly promote basic drug supervision and inspection.

It is reported that conducting full-species coverage testing of basic medicines is one of the key tasks identified by the General Office of the State Council in the “Key Work Arrangements for the Five Key Reforms of the Medical and Health System in 2010” and the “Main Working Arrangements for Strengthening Basic Drug Quality Supervision in 2010” of the State Council. It is also a key task that the food and drug supervision system must complete this year. In order to implement the basic drug quality supervision and management targets set by the General Office of the State Council, in May this year, the State Council's Medical Reform Office and the provincial people's governments, the State Bureau, and the provincial bureaux respectively signed a responsibility statement, clarifying the specific tasks and work requirements for basic drug sampling inspection.

Bian Zhenjia pointed out: “Basic drug supervision and inspection work has entered a critical stage of difficult and comprehensive advancement. Can we accomplish the goals and tasks? It mainly depends on the implementation of the organization. All localities must follow the deployment requirements of the General Office of the State Council and the State Bureau. Work hard to ensure that basic drug sampling tasks are completed on schedule."

In this regard, Bian Zhenjia requires all localities to attach great importance to it. First, it is necessary to find out quickly the bottom line of the successful bid-winning companies and the successful bidders in the area under their jurisdiction, and carry out random inspections. The second is to focus on key issues, focus on key issues, and focus on The third is to release basic drug supervision and inspection results in a timely manner, and to dispose of unqualified products and related production, operation, and use units in accordance with the law; Fourth is to strengthen communication and coordination and to grasp in a timely manner. The progress of basic drug sampling inspection work in this jurisdiction is reported to the State Bureau on a regular basis as required.