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The new drug classification cited 3 drugs generic situation

Number of visits: Date:2015-08-26 08:47

"The State Council on Reform of drug and medical device review and approval system (44)" the drug is divided into two types of drugs and generic drugs, and the new drug from the current "not listed in China's territory" to "not in the domestic and foreign sales of drugs", the generic drugs by the current "imitation of existing national standards" to "copy and the original drug quality and efficacy of drug". At present, with the new drug registration classification, matching scheme is still brewing, but the management department of drug classification of re tuning, will undoubtedly lead to the traditional classification of three types of drugs into the generic category, which of the drugs register listing, market development produced a huge impact. In the recently held in Guangzhou with the freehand on the forum, the experts expressed concern about the prospects for the 3 types of pharmaceutical companies.

Focus on 3 kinds of Medicine

Compared with 1.1 class of drugs, the three kinds of new drug development becomes more and more mature, because of 3 class drug development costs and risks compared to 1.1 new smaller, so the domestic pharmaceutical industry in three kinds of new drug development and cybersquatting is open enough horsepower, competition is becoming increasingly fierce.

Clearly, the policy level of the adjustment lead to grab the 3.1 category of the registered game has quietly changed. With freehand brushwork in traditional Chinese painting forum initiated, Beijing Kebei source of bio Pharmaceutical Technology Co., Ltd. chairman Cheng Zengjiang said, the past based on the protection of national industries concept, through the "three reported three group" means the drug imports of the time delayed as much as possible, the new policy orientation occurred a sudden change, import review is expected to really get up to speed. "The Chinese clinical drug can be and have been put in the priority position, accelerate the imported drugs approved, 3 class of domestic medicine change into 6 categories, the original did not get clinical approval directly back to the trial, even the chance of 3 kinds of drugs are not."

In fact, 3 class of drugs with 4 years of drug monitoring period, before maturity. CDE is no longer accepting registration of imported and domestic application, therefore, the industry generally will be "monitoring" and "patent" equated, class 3 drugs therefore both "head fake" and "new drug" title. However, the preferential treatment in the pharmaceutical industry is also highly controversial. "3 categories of drugs if you become generic drugs to the monitoring period? If there is no point in the period of monitoring, there is no sense in the 3 categories of drug monitoring period. The convergence of the old and the new system also takes time to observe." Cheng Zengjiang if it is speculation.

Without the skin, maojiangyanfu. According to the new release of the reform program of the 44, the logic, the future will be fully abolished the 3 categories of new drug registration, monitoring period will naturally be no longer exist. Lilly Suzhou Pharmaceutical Co., Ltd. registered deputy director Zheng Yu Wu believes that the three kinds of drugs is not a kind of innovation, not an imitation, not long-term and permanent. "Unreasonable things will be eliminated sooner or later, the world is reasonable, but also must be vigorously to do; later we can go to the imitation, but may not get past the special policy."

For the 3 category of drug development level may change, Guangdong Biomedical Innovation Technology Association President Lu Wenqi admitted that the market is now very limited role in monitoring, even if the new batch of drugs, there is a need to enter the medical insurance directory can be a big bang, but health care and tender policy is now in the adjustment, the market is still watching. "Rely on three types of agents to engage in research and development, enterprises is still very difficult to survive, a variety of four or five, a dozen or so enterprises production, final tender spelling low, market or can't do, enterprises can only earn money hard; China's new drug research and development or seeking to upgrade technology and innovative new drugs often seem difficult, but insisted on and found no so difficult, past research and development of new drugs are for fast, convenient, companies need to bear the heart to, whether it is new drugs and generic drugs, should be solid practicing internal strength."

New classification test of generic quality

After 3 kinds of drugs are changed into generic drugs, the registered route will be carried out in the way of the biological equivalent test (BE) in accordance with the new document spirit. Previously, CFDA relevant person in charge had pointed out that in vitro testing is the foundation, and encourage to do in vivo test. "In vitro is dissolution test, dissolution rate curve and the original research comments we deemed equivalent bulk; if in vivo dissolution is not possible, it is necessary to do biological equivalent, bioequivalence is most can prove an important channel for the drug's efficacy is invalid and equally effective."

In exchange with the freehand forum, industry insiders have their own views: on the one hand, some experts believe that generic pharmaceutical registration is likely to be further graded, the adaptation of the disease may be associated with race, individual differences in the larger varieties, clinical trials are still relatively high, and some species only need to do BE; on the other hand, the relationship between the biological equivalent and the dissolution curve is not directly equivalent. Cheng Zengjiang told reporters that the dissolution curve and BE different, BE and clinical equivalent are not the same. "The 3 category of drugs required to do BE may need to re modify the prescription and process, then the enterprise faces two choices: in the end is in accordance with the consistent in vivo method to do, or directly in the BE go in the end, which requires the enterprise to weigh."

Wu Xiaoming, vice president of Anhui pioneer pharmaceutical further said, before the release of the 44 is very concerned about the pharmaceutical equivalent, in fact, as long as the control of impurities, the four curves to achieve the same process, the process can have a variety of options, such as the choice of active agents and add

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