A few days ago, the State Food and Drug Administration issued an announcement that it will write off approval documents for five pharmaceuticals such as domperidone suspension (trade name “Motilium”), including three children's drugs, including “Ai Chang” and "Motilium" in Pediatrics, "Saizen".
According to media reports, two years ago, China's Food and Drug Administration approved more than 180,000 articles of drugs’ application. As of June 4, the reporter saw in the official website of the Center for Drug Evaluation of SFDA that there are 170,155 drug approvals in China, including 165,989 domestic drugs and 4,166 import approvals. This also means that tens of thousands of drug approvals have been written off in just two years. Industry sources pointed out that the large-scale elimination of drug approvals is the result of market competition on the one hand, and on the other hand, it also shows that the supervision and management departments are increasingly strict with the management of drug safety. With the continuous implementation of consistency evaluation, there is a large number of drug approvals that will be cancelled at the end of this year.
▍ Another 5 drug approvals were written off
According to the announcement of the Food and Drug Administration, the five drugs were domperidone suspension from Xi An Janssen Pharmaceutical ("Motilium" in Pediatrics), Pediatric pseudoephedrine dextromethorphan drops from Johnson & Johnson Pharmaceuticals (commercial name: Ai Chang), and Merck's. injectable recombinant human growth hormone (trade name: Saizen), Johnson's Simeprevir (trade name: Olenson) and Novo Nordisk’s Aspart insulin injection (trade name: NovoRapid).
It is reported that the cancellation of the five drug approvals was initiated by a number of pharmaceutical companies including Xi An Janssen Pharmaceutical. Xian Janssen Pharmaceuticals publicly stated that the decision to stop production and supply of pediatric “Motilium” was because the company adjusted the production focus of the new supply chain innovation center in Xi An.
Johnson & Johnson Pharmaceutical also said that the decision to cancel the "Ai Chang" product approval is based on the company's goals and product portfolio assessment to ensure that the resources are centralize
d to develop and produce drugs that can meet the major medical needs of Chinese patients.
In addition, the reporter also learned from Merck that the company stopped producing “Saizen” four years ago. The product approval document has long been idle for a long time. Novo Nordisk stated that the information of Aspart insulin injection is a normal process according to the laws and regulations of the country, and there is no impact on the production and sales of the product. Currently, Aspart insulin injection has got a new production batch number.
▍ Companies actively apply for cancellation due to the fierce market competiton
According to statistics, unconsciously, over the past two-three years, China has written off tens of thousands of drug approvals. And voluntarily applying for cancellation of a drug approval like Xi An Jansen and Merck is not uncommon.
Why to write off the approval? One of the main situations is that the approval period has passed and the company has not re-registered in time. It is reported that in China, the validity period of drug approvals is generally 5 years, and then it is necessary to register again, otherwise it will be written off. This may mean that there is little market demand and drugs do not make money, so that pharmaceutical companies give up re-registration.
According to industry analysts, in recent years, with the rise of domestic brands such as Sanjiuweitai and Sidashu, Motilium, which has repeatedly been questioned on banned standards, has seen its market share shrink further. With the regulatory authorities strengthening management on pharmaceutical products containing ephedrine, the sales of Ai Chang must be influenced. In this case, the drastic removal of a drug approval by a company will be a matter of course.
In addition, since most companies can only produce and sell several core products, for the sake of cost, they will also choose to voluntarily cancel those idle product approvals.
▍ Drug varieties with over-repeated production is facing elimination
In fact, most of the drug approvals that have been written off are not exclusive, but produced by many manufacturers. The reporter found that there were already 31 approvals (domestic-made 25, imported 6) of the drugs for injectable recombinant human growth hormone. Due to the large number of substitutes, a company that stopped production would not affect the normal use of consumers.
Industry sources pointed out that there are many cases of over-application of pharmaceutical products in China, which is related to the previous Chinese pharmaceutical market environment, drug production licensing system, and the low cost of drug registration applications. According to the list of excessively duplicated drugs previously announced by the State Food and Drug Administration, drugs such as glucose and amoxicillin are in the “hard-hit areas” for production and amoxicillin has currently 634 approvals for only domestic drugs,while glucose has currently 153 approvals for only oral glucose.
The production was crowded and the competition was extremely overwhelming. There were drug companies that couldn't stand by and voluntarily gave up drug approvals. In June last year, the State Food and Drug Administration issued an announcement on its official website that according to the application of four companies, including Huiyinbi Group and Zhejiang Yadong Pharmaceutical Co., Ltd., the General Administration decided to cancel the registration approval documents for 10 drugs such as amoxicillin capsules. With the continued implementation of antibiotic policies at the national level, it is expected that more antibiotic drug manufacturers such as amoxicillin will abandon the approval and withdraw from the market.
▍Strict management and consistency evaluation expedite elimination
In addition to the voluntary application for cancellation by companies, many approvals have also been forcibly cleared by the drug regulatory authority. For example, in July 2015, the Food and Drug Administration cancelled the approvals of Yinqiaojiedu tablets, Moxilin capsules, gelatin hollow capsules and other drugs, on the grounds of “the expiry of the validity period of the drug approval number and the failure to re-register”, “has revoked the “Drug Production Licence” and “approved technology transfer” , etc.
In addition, consistency evaluation will also accelerate the elimination of drugs. Since 2016, the General Office of the State Council has issued the Opinions on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs, which sets a time limit for the completion of consistency evaluation of domestic generic drugs. According to the requirements, oral solid preparations of chemical generic drugs listed on the National Essential Drug List (2012 edition), approved for marketing before October 1, 2007 must be evaluated for consistency by the end of 2018. If they are not approved, the drug approval number will be written off directly. This involves a total of 17,740 ratification numbers or registration numbers for 289 varieties.
According to the latest information released by the Food and Drug Administration Approval Center, there are currently four batches of a total of 41 varieties have passed the consistency evaluation of generic drugs. However, there are only 11 in the 289 basic drug list. With the deadline for 2018, this also means that there are still tens of thousands of approvals that will face the risk of elimination by the end of this year.
As is analyzed that under the dual role of policy guidance and market regulation, some drug approvals with repeated and spotty approvals are gradually being written off. This is actually the performance of the “transformation and upgrading” of the pharmaceutical industry. It is reported that at present, there are still more than 170,000 drug approvals in China, and the number is large. Through the consistency evaluation,faulty generic drugs are eliminated, which will help improve the quality of medicines and promote safe, effective, and accessible medicine for the people.