Drug marketing authorization holder will move the system or change drug

The so-called pharmaceutical marketing authorization holder system refers drug approval number holders, including pharmaceutical production enterprises, research institutions and researchers, in their own name to market the drugs, and be held accountable and Drug Lifecycle of a system.

Drug marketing authorization holder system is an important system currently used by the international community generally, the core of this system is to encourage pharmaceutical research and innovation, mobilize the enthusiasm. At the same time, this system can also optimize the allocations of resources, avoid companies large and small and complete, suppressing redundant construction.

November 4, in the second session of the NPC Standing Committee Seventeenth Meeting of the closing session, with 149 votes in favor, one vote against and 4 abstentions vote by the NPC Standing Committee on Authorizing the State Council to carry out parts of Drugs Marketing Authorisation holder decided the pilot system and related issues.

"Drug marketing authorization holder system is an important system currently used by the international community generally, the core of this system is to encourage pharmaceutical research and innovation, mobilize the enthusiasm. At the same time, this system can also optimize the allocations of resources, avoid large and comprehensive enterprise , small but complete, inhibition of low-level redundant construction. "legal Secretary, China food and Drug administration Xu Jing and a press conference held at the General Office of the NPC Standing Committee, said.

The core of the system: First, in addition to drug companies, drug research and development institutions and researchers may also apply for and obtain drug approval numbers, becoming the drug marketing authorization holders. Second, the drug marketing authorization holder may set up its own production of drugs, drug companies may be entrusted to other production. Third, the drug marketing authorization holder in his own name products to market, and bear the corresponding legal responsibility.

It is with the current national drug regulatory law has completely different now only drug manufacturers can apply for drug registration, to obtain drug approval number. With the rapid development of China's pharmaceutical industry, as well as the concept of continuous improvement and drug regulatory system, this shortcoming product registration and production licenses bundled management system began to emerge.

In 1987, China began the formal implementation of the drug review and approval system for new drug approval by the State, by local generic drug approval, resulting in many cases approval number. In 1998 the National Drug Authority was established in 2001, it began to clean up the approval number, the establishment of a unified national sequence (ie 国药准字号). However, due to strict, no clinical value of some drugs from the "landmark" to "GB." At present, China has a drug approval number 187 000, of which there are 168,000 drug approval number is before 2007, most of the production is not sleeping symbol.

Economics and public policy scholar Fan must have written that without scientific validation, safety, efficacy is unknown, controllable quality is poor circulation of medicines on the market, it will bring significant safety risk to public health. For example, traditional Chinese medicine injection is no rigorous clinical validation, resulting in a large number of post-marketing adverse events, a greater impact Shuanghuanglian Qingkailing, Houttuynia injection event. Quality and safety risks of the drug into the formal channels, including access to health insurance directory, the market "medicine expulsion of inferior quality" phenomenon.

Situation drug quality problems, whether it is in a safe state of the placebo, or of inferior quality expulsion quality medicine, drugs indeed worrying.

"The current management approach is not conducive to encouraging first pharmaceutical innovation and is not conducive to the allocations of resources. Implementing drug marketing authorization holder system is conducive to fully mobilize the enthusiasm of developers, promoting pharmaceutical innovation, and to approve the listing of drugs can be expanded rapidly the marketplace. Second, it helps to optimize the allocations of resources, suppressing low-level redundant construction, promote structural adjustment and industrial upgrading, while conducive to the implementation of corporate main responsibility, strengthen drug quality control, improve the quality of drugs. and it is conducive to innovative medicines governance mechanism, give full play to the role of government, business and the market in three to strengthen drug management. "Xu Jing and representation.

However, the drug marketing authorization holder system can change this situation, there is just to try the state.

"The past is the production and licensing combined, can now be separated, this system allows the addition of non-pharmaceutical production enterprises to apply for drug batch of natural persons, the other has not changed anything in particular, but for the future of the past holders of the invisible how this is a problem. "a pharmaceutical industry experts said.

Drug marketing authorization holder system, although a change in the past pharmaceutical companies monopoly drug approvals phenomenon, but some medicines researchers did not hold much optimism.

"Currently this pilot, the media interpretation of the transition, too optimistic, in fact, very simple, look at the scope." A Drug researchers said, "If confined to drug manufacturers, research institutions, then temporarily not what many people think research spring staff to the research structure may also be certified as suppliers, etc., in fact, at least for now can not, unless there is no range limit, unless it is pure innovative drugs or a class of drugs, just to have reported up, or else can be expected or enterprises as the mainstay to this newspaper, and the amount will be very small. "

At the same time, he said, to holders responsible for the safety of their drugs, responsible for the quality, the holder will naturally go to the manufacturers specifications for processing. Because holders of qualification, when to have a special quality management system, specifically adverse risk control system, the need for specialized person in charge. "How could a person get so much? Particularly safe monitoring of adverse reactions after risk control and new drugs, which is the mah (pharmaceutical marketing authorization holder system) responsibility ah .mah just want to sell drugs , but also to bear the responsibility ah. "

Xu Jing and describes that pharmaceutical marketing authorization holder system, the range of the whole field of medicine. Implementation of marketing authorization holders of medicines innovation system actually involves a lot of relevant legal system, where in fact the study of drugs among marketing authorization holder system, the core is the marketing authorization of the rights, duties and responsibilities, as well as the actual production rights, obligations and responsibilities of the reconfiguration.

Drugs from marketing authorization holders point of view, he should bear the corresponding legal responsibility for the entire life cycle of drugs, where drugs such as marketing authorization holders should register link obligations related to the management of national drug registration requirements of the relevant laws and regulations, and information on the application of the authenticity, accuracy and completeness. In the production process, if commissioned production, should be entrusted to a qualified real producers, signed the relevant agreement, while actual production guidance and supervision of the production of qualified enterprises in accordance with relevant provisions of the State Drug Administration of the product. After the market, he has to bear-market monitoring of adverse reactions, listed after the evalsuation and product recalls, liability, which is the main responsibility of the marketing authorization holders.

From the perspective of producers, production companies should be signed and the actual marketing authorization holder agreement, specifying the rights, obligations and responsibilities, which is a contractual obligation or contractual liability. At the same time, he must follow the requirements of the relevant laws and regulations of the country drug production to production to meet the quality requirements of drugs.

"Listed products if the damage to consumers, consumers can actually in accordance with existing laws, such as the listing of drugs to the Consumer Protection Law, Tort Liability Act and other license holders on request and to be the actual manufacturer request belonging to the actual production of corporate responsibility, the drug after marketing authorization holder compensation, he can recover the actual manufacturer. If you belong to the responsibility of the marketing authorization holder, the actual manufacturer after compensation to be listed to the drug license holders Some recovery, this is actually the first responsibility system. "Xu Jing and representation.

It is understood that in the "About the State Department authorization to carry medicines in parts of the pilot system of marketing authorization holders and issues related to the decision (draft)" Voting is issued, the authorization of the State Council in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, Sichuan ten provinces and municipalities to carry out the drug marketing authorization holder system pilot.