Shao Mingli, director of the State Food and Drug Administration, revealed at the working meeting of the drug surveillance system last week that the supplements for essential drugs in provinces across the country will be incorporated into the electronic surveillance platform of the drug surveillance system before the end of February 2013.
A drug regulatory system source disclosed that the new powers obtained by the Food and Drug Administration are mainly aimed at pharmaceutical companies that do not want to access the Internet and have not entered the electronic regulatory platform. They can strictly prohibit their participation in the bidding and procurement of essential drugs. "At that time, the whole process of tendering basic medicines, sources of pharmaceutical raw materials, production, and circulation will be publicized and supervised."
This person believes that the expansion of the drug administration system is an auxiliary strategy for the gradual deepening of the basic drug system in China.
The disappearance of the winning bidder
"This move is very useful, bidding companies have access to the network." The above drug supervisor said that the State Food and Drug Administration has strict penalties for the pharmaceutical companies that do not want to enter the network, did not enter the electronic regulatory platform, strictly prohibited the basic Drug procurement.
The newspaper learned that the Drug Electronic Supervision Network is a unified drug monitoring system covering the whole country. Its main functions include making medicines from the manufacturing, distribution, transportation, storage, and distribution to medical institutions in the drug regulatory department. Under monitoring. Real-time query of the production, operation, inventory, and flow direction of each batch of drugs. If there are problems, they can quickly trace the flow and recall products.
Based on the supervision of the rights of 307 kinds of country-based pharmaceuticals, this right of the future drug administration system has been expanded again. According to Shao Mingli, the basic medicines supplemented by the provinces in the future will also be included in the electronic surveillance platform of the drug surveillance system.
At that time, the entire bidding, production, raw material sources, and distribution of the new essential pharmaceutical system in China will be subject to special supervision by the drug surveillance system. Since 307 kinds of drugs are used as basic medicines, the provinces will supplement basic medicines by more than twice the regional incidence. Such as Jiangsu, Shanghai and other places added up to 700 to 900 kinds of drugs.
The extension of the authority of the Food and Drug Administration stems from the difficulties in the production and distribution of essential drugs for the essential drugs.
According to drug company sources, on September 1, 2010, Anhui Province undertook exploration under the instruction of the National Medical Reform Office, and took the lead in implementing the procurement of essential drugs by province as the unit. With the bidding and procurement, drug prices were reduced by about half, but after the tender ended, the hospital began to issue drug demand orders, when the pharmaceutical companies to enter the drug, some of the basic drugs but disappeared and did not supply to the hospital.
According to a person from the Institute of Medicine and Economics who visited Anhui Province, about 50% of the medicines for the bidding in Anhui have not entered the production, distribution, and hospital links. In the opinion of the Anhui Health Department and the Ministry of Health, the recruitment and non-production seriously disrupted the implementation of the essential medicine system. "Regardless of whether you are unwilling to produce because of a loss, or if you were originally bidding in a bad faith, you should understand the seriousness of a policy," said a health system expert.
It is understood that based on the State Administration of Food and Drug Administration's advance regulatory basis, the National Health Reform Office, the National Development and Reform Commission, and the Ministry of Health and other ministries have been deliberating and decided to once again introduce the regulatory authority of local supplemental medicines into the drug surveillance system. This means that while the drug regulatory system is monitoring the production and quality of essential drugs, the information of commercial distribution companies will also enter the network and be supervised at the same time.
Essential medicines are fully incorporated into the electronic regulatory system and are part of the State Food and Drug Administration's "12th Five-Year Plan." It is understood that at present, the State Food and Drug Administration is working with Unicom to jointly develop a software, and future drug purchasers using mobile phones will scan codes through mobile phones to search for drug information within the scope of essential drugs, such as sources, raw materials, and ingredients.
Food and Drug Administration Authority
It is understood that the new national essential medicine system was implemented in August 2009, and 307 kinds of basic medicines are listed as national types, reaching over 2,000 items of regulations. The use of these medicines is fully reimbursed by patients.
According to the Ministry of Health, drug prices in the Essential Drugs List have been reduced by an average of 25% compared with the past after the tender for drugs. As the prices were lowered by 25% at the time of bidding, the primary medical institutions cancelled the 15% markup, sold at zero price, and the people at the grassroots level were reduced. â€œThe profits of this part of the drug are very low. To ensure that pharmaceutical companies produce and distribute in order, they must be strictly regulated.â€ According to the above-mentioned health system personnel, 307 drugs are the most important part of the new medical reform and the establishment of a new basic drug system. Implementation, the State Council Health Reform Office issued a document requiring full electronic surveillance of essential drugs.
In fact, if we look at the current market mechanism, the formulation of drug prices is under the control of the Development and Reform Commission; the Ministry of Health is responsible for implementing the system in medical institutions, while the pharmaceutical safety of pharmaceutical companies belongs to the SFDA. "Now pharmaceutical companies have completed the market transformation, the vast majority belong to private enterprises. What drugs are produced and production of certain types of drugs are suspended are all market mechanism adjustments. They have the final say, and the Ministry of Health, the National Development and Reform Commission and the Food and Drug Administration cannot intervene. According to the above-mentioned drug administration personnel, due to the regulatory system, some of the low-priced drugs that had won the bid disappeared for various reasons. â€œLast year, several ministries and commissions discussed several times and felt that the Food and Drug Administration had an advantage in controlling this phenomenon.â€ According to a person from the health system, the advantage of the Ministry of Health is to administer medical institutions. The advantage of the NDRC is to set prices while the FDA supervises them. The quality problems of pharmaceutical companies and the contacts with pharmaceutical companies are even more profound. Through quality and the addition of penalties, this phenomenon can be constrained.
It is understood that in order to obtain this new power, the Food and Drug Administration also repeatedly fought. In March of this year, Shao Mingli said at a conference that in 2011, all basic medicines should be electronically supervised, and the construction of information systems must be closely linked to basic drug supervision. This is the policy support and work we have won. opportunity.
After obtaining this job opportunity, the State Food and Drug Administration formally implemented the electronic supervision of essential drugs in August 2010. First, 307 kinds of national drug-based drugs were included in the scope of supervision. The supplemental essential drugs in the provinces of the future will also be included in the electronic surveillance platform of the drug surveillance system.
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