Consistency evaluation lifts more than half of the supply side reform drug approval documents into "life and death"

Source: on October 28, 2016, the State Food and Drug Administration issued a notice on the implementation of the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs This time, CFDA designated 289 generic drugs to complete the consistency evaluation by the end of 2018 In addition, the General Administration said in the announcement that after the first enterprise variety passed the consistency evaluation, it would not accept any application for the same variety from other pharmaceutical manufacturers three years later Once this happened, it attracted wide attention in the industry Shi lichen, head of pharmaceutical management consulting in Dingchen, Beijing, told Securities Daily that this is the supply side reform of the generic pharmaceutical industry, and the merger and acquisition of the pharmaceutical industry will accelerate in the future "50% of drug approvals will be eliminated in the future" However, for this matter, the attitude of Listed Companies in different segments is different For this matter, a person from a pharmaceutical listed company once told reporters that the company will pay a high cost for conducting generic consistency evaluation, and the company is still waiting for this policy However, at present, some pharmaceutical companies have begun to take action, including selecting varieties, queuing for clinical data, etc In March of this year, the general office of the State Council issued the opinions on the evaluation of the quality and efficacy of generic drugs On May 26, the State Food and Drug Administration issued the relevant announcement on the implementation of this opinion, which clarified the six modules of the evaluation object and implementation stage, the selection and determination of reference preparation, the research content, procedure, recheck, inspection and verification, and safeguard measures of consistency evaluation "Before 2007, the regulation of drug approval in China was relatively loose, and a large number of drug approvals entered the market; after 2007, the regulatory authorities raised the threshold of drug approval." A person familiar with the matter told reporters According to the report of Southwest Securities, at present, China has nearly 5000 pharmaceutical preparation manufacturing enterprises, about 170000 pharmaceutical approvals, and the industry concentration is far lower than the international level "China is a big country of generics, but not a big country of generics The current situation of China's generic drug market is that more than ten or even dozens of enterprises have approval documents for the same drug The concentration of the industry is low and there are many kinds of "safe and ineffective drugs" everywhere An industry source told reporters According to the Research Report of Societe Generale Securities, the top five drugs in the first batch of consistency evaluation varieties are Norfloxacin Capsules, erythromycin enteric coated tablets, metronidazole tablets, Cefalexin Capsules and isoyancai tablets There are more than 100 enterprises with these drug approval numbers However, with the 180 degree turn of the policy, this situation will change greatly in the future According to the requirements of the announcement issued by the State Food and Drug Administration on the implementation of the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs, 289 generic drugs will be evaluated by the end of 2018 Among them, the State Food and drug administration stipulates that "after the first variety passes the consistency evaluation, three years later, it will not accept the consistency evaluation application of the same variety from other drug manufacturers." "It's very critical," he said "After the first enterprise variety passes the consistency evaluation, the regulatory department will re issue the drug approval and production approval If the enterprise does not do so, it means giving up the drug approval The original approval is equivalent to waste, and the drug can no longer be produced and sold " In the future, with the increase of coverage, 50% of drug approvals will be eliminated, which will help to improve the industry concentration, Mr Shi said "Due to the high cost of consistency evaluation, enterprises have begun to select varieties and make consistency evaluation for some valuable drugs." According to the report of Societe Generale Securities, the enterprises selected for the first batch of approval documents of consistency evaluation varieties are Shanghai Pharmaceutical Group, China Resources Shuanghe Pharmaceutical Co., Ltd., Guangyao Baiyunshan Pharmaceutical Group, Harbin Pharmaceutical Group Co., Ltd and Shanghai Fosun Pharmaceutical (Group) According to the provisions of the State Food and drug administration, the subject of this evaluation is mainly generic drugs approved for listing before the implementation of the new registration and classification of chemicals, including domestic generic drugs, imported generic drugs and the original research drugs Two types of drugs may benefit: drugs produced and listed in the same production line in China and approved for listing in the European Union, the United States or Japan; generic drugs produced by domestic drug manufacturers approved for listing in the European Union, the United States or Japan However, it is inevitable for most of the generic pharmaceutical enterprises to be robbed, and the brand shuffle of the generic pharmaceutical industry is coming "The participants have not been finalized yet, but at present, most of them are original research drugs, which is a great pressure for enterprises." An industry person introduced to reporters that some pharmaceutical companies had incomplete clinical data and fraud in the process of drug declaration before this, which was far from the original research drug In addition, the consistency evaluation of generic drugs increases the cost of enterprises In the past, the price of a drug for clinical data may only be 500000 to 600000 yuan, but now due to the limited number of clinical bases and the tight time, the clinical trial has traffic jams At present, the price of a drug for consistency evaluation has risen to 5 million yuan, some even up to 8 million yuan Because the price of consistency evaluation is rising, many enterprises give up some varieties, while some enterprises simply give up the consistency evaluation "This is a turbulent process In terms of the final effect, it will help the whole pharmaceutical industry upgrade and improve the quality of drugs." Those in the industry told reporters In addition, "to some extent, this will also intensify the merger and reorganization of the industry Some small enterprises with weak capital strength can seek the support of large enterprises if they have good varieties " Shi lichen said However, analysts believe that this is a great advantage for cro enterprises (pharmaceutical R & D Contract outsourcing service institutions) According to Societe Generale Securities, the market space of consistency evaluation is about 45 billion yuan to 60 billion yuan, among which more than 3 billion yuan of new profit space is brought to cro industry In addition, in the case of strict pre clinical and clinical trial supervision, high-quality cro enterprises are expected to achieve the integration of the industry through elimination and merger, and the cro industry will usher in the process of concentration improvement.