The power of drug approval registration reform, which lasted nearly two years, was shown on July 4. Recently, total bureau of national food drug safety issued "about 106 companies the notice to withdraw the application for 135 drug registration no. 80 (2017)", to carry out clinical trial data check list since voluntarily apply for withdrawal of drugs and drug firms listing in public.
Multiple products of listed pharmaceutical companies "medium gun"
On July 22, 2015, the national food administration of drug safety release administration of the state food and drug supervision and administration of a drug clinical trial data comprehensive inspections of announcement no. 117 (2015) "(hereinafter referred to as" the no. 117 "), put forward "in the history of the strict requirements of data verification", so the medicine dubbed the July 22 massacre ".
Journalists initially found that listing involved 18 a-share listed companies, 6 H shares listed companies, including beida pharmaceutical, red sun, the sea is pharmaceutical pharmaceutical, nolato, group, Shanghai "and other well-known drug firms related species. (list of attached)
Specifically, in the list of application for withdrawal of drug registration in the no. 117 of 2015, bayda pharmaceutical has voluntarily withdrawn a new drug for the drug of chlorofalabine injection (adm c xhs1200249). The relevant person in charge of beida pharmaceutical told reporters: "at present in the part of the original research materials in the existence of data integrity is not in conformity with the supplementary study, according to the drug registration regulations for submission for new drug registration."
The red sun pharmaceutical company withdrew a new Chinese medicine in the list of no. 81 of 2016, the brain - heart polypeptide capsule (CXZR1300010). According to red sun, head of the pharmaceutical industry: "the product research and development for a long time, so the related clinical data are not accord with the requirement of current policy, so the company apply for withdrawal, consider to do clinical trials supplement data." However, as a result of the reclinical investment, the company is still considering the related issues.
In fact, the red sun industry has revealed the dilemma that most drug companies face when they apply for retraction. Is it necessary to invest heavily in reclinical practice? At present, the market price of a single variety of drugs in China has reached 3 million to 6 million yuan, compared with between 50 and 600,000 yuan.
The July 22 tragedy continues to ferment
According to article 117, the applicant found that the clinical trial data was not true and incomplete and could be submitted to the state administration of food and drug administration for withdrawal of registration. If it is not withdrawn, the consequences will be serious once the problem is detected: the applicant who has found a problem with the authenticity of the clinical trial data in the verification will not accept his application within 3 years. The drug clinical trial institutions are falsified and disqualify drug clinical testing institutions; The persons who have committed violations in the clinical trials shall notify the relevant departments to investigate and investigate according to law. The list of fraudulent applicants, clinical trials, contract research organizations and related responsible personnel will be blacklisted.
According to the announcement by the state administration of food and drug administration, many of the 1622 admissible Numbers were admissible before 2008. The personage inside course of study points out that at present the high-standard requirements for clinical data to examine 2008 years ago, according to the clinical project basic don't have much project can conform to the existing standards, estimated that most of the varieties to resubmit the registration queue.
"In the short term, most of the listed pharmaceutical companies are resubmitting their clinical data self-report with the review of pharmaceutical reform, which may lead to some new drugs being delayed." The head of a listed company said.
A securities analyst pointed out that reform of drug approval in at the same time, to improve the quality of drug research and development barriers and to pharmaceutical research and development and the CRO industry in the future more standardization and centralization, promote the industry's evolution. In the future, the leading enterprises with r&d advantages and industry advantages will gain favorable market competition environment.
In fact, under yan wei, the reform of the drug trial has achieved remarkable results. According to relevant data, 32,428 drug registration applications were accepted by the state administration of food and drug administration in 2015, dropping to 2,20034 in 2016, a 38.22 percent year-on-year decrease. The number of new drugs and generic drugs was reduced to 818 and 647.
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