The fever of going to Hongkong for injection has led to a shortage of vaccine supply in Hong Kong. In fact, the price of vaccine is only more than 4000 Hong Kong dollars, but the price is also rising because of the shortage of supply, which is nearly doubled. An agent of a part-time vaccine intermediation service in Hongkong said. This situation is expected to be eased with the conditional approval of the 9 valent HPV vaccine in the mainland in April 28th. Compared with the 2 price and 4 valent vaccine, the 9 valent vaccine was approved by the Chinese pharmaceutical regulatory authorities for 8 days. For the specific time of listing of vaccines, Mercedes recently responded to Beijings report that it is coordinating with relevant parties to promote the process of vaccine marketing. The 9 price vaccine shortage caused by the injection tide in Hong Kong Since 2006, the worlds first HPV vaccine (Jia Daxiu) Gardasil (Jia Daxiu) has been listed on the market by the US Food and Drug Administration (food and Drug Administration). There are three kinds of vaccines used worldwide, namely, the 2 price vaccine Cervarix (Xi Ruishi) of the British GlaxoSmithKline Co, and the Jia Daxiu 4 and 9 Price vaccines of the United States of merschon. But until 2016, Chinas HPV vaccine market is still blank. Many mainland consumers are willing to go to Hongkong and Korea at no cost. Since 2016, the 2 and 4 HPV vaccines have been listed in China, but there is no stopping the footsteps of the mainland women going to Hong Kong for injections. Many consumers still choose to go to Hongkong to vaccinate the 9 price HPV vaccines that have not yet been listed in the mainland. The influx of mainland consumers has touched the sensitive nerves of the market, and the price of 9 price Jia Daxiu (Hongkong called Wei Wei Miao) has risen. Recently, the reporter consulted with a mainland intermediary for an injection to Hong Kong. The customer service gave a preferential price of ten thousand yuan (a total of about 8000 yuan), and indicated that the original price of the vaccine should be HK $12000. Another agent in Hongkong who worked part-time as a vaccine agent told reporters that the vaccine was actually only more than 4000 Hong Kong dollars, because the demand for the vaccination was large, the supply of the vaccine was insufficient and the price was rising, and it was nearly doubled. Reporters learned that last year, Hongkong suffered a HPV vaccine shortage, even if the appointment to the clinic in advance, there may not be a needle to fight. Not only that, according to the agent, many customers made appointments to Hongkong, but they were told that they did not have a needle at the clinic. Due to the tight supply of vaccine, the injection procedure that should have been completed in half a year must be postponed to a year. There are also a lot of consumer spending on Hongkong. The three price immunization procedure is 9 price, which means three trips to Hongkong. Netizen CICI3 completed the vaccination at the end of the month, she calculated an account: the vaccination cost plus the trip to Hongkongs food and clothing, less say twenty thousand yuan. The 9 - price vaccine was listed on the mainland for 8 days In April 28th, the State Drug Administration approved the 9 price HPV vaccine on the mainland, which is suitable for women aged 16 to 26. By combing official public information, the timetable for the 9 price HPV vaccine is gradually clear: in April 20th, the drug trial center of the State Administration of drug administration accepted the 9 price HPV vaccine submitted by the company of merschadon. Only four days later in April 24th, the National Drug Inspection Bureau of drug review center official website published twenty-eighth batches of priority review procedures to be included in the list, the 9 price of the vaccine listed in the list. Public information showed that the vaccine was listed in line with the obvious clinical advantage standard. On the morning of April 28th, Zeng Yixin, deputy director of the national health and Health Committee, revealed that the Department of pharmaceutical supervision was speeding up the 9 Price cervical cancer vaccine work, and striving to approve the listing at an early date. In the evening of April 29th, the official website of the State Administration of Drug Administration issued a message that the 9 price HPV vaccine was approved for the prevention of cervical cancer, and the approval time was April 28th. The application for submission of listing from April 20th to April 28th was officially approved in 8 days. Many industry experts pointed out that the 2 card vaccine listing process card in clinical trials. Previously, the Chinese drug supervision department did not approve the clinical trial data of the new drugs abroad. The imported drugs must be tested in China after two stages of clinical trials abroad, and after the completion of the three phase of clinical trials, they can be approved to be listed in China. In addition, the disadvantages of too long approval time also point to the drug approval system. Prior to this, Chinas drug review process did not have a green channel for priority review. No matter whether the clinical needs are urgent or not, the new drugs should be in line with the come to before the market is listed, waiting for the review of the Department of drug supervision, and the shortage of the reviewers of the drug supervision department, which leads to the big traffic jam in the year of drug approval. The superposition of various factors often leads to a new drug coming into China 5 to 7 years after being listed in Europe and America. For a long time, China is a big country of generic medicine. The weak industrial base has decided that the drug approval capacity is not strong, which shows the shortage of professional talents and the shortage of international standards. Hu Yinglian, an associate professor of National School of Administration, pointed out the problem when interviewed by the Beijing News. The speed of approval was benefited from the new administration of drug trial The approval rate of the 9 valent HPV vaccine is unprecedented. It is known as the rocket speed by the industry. Hu Yinglian pointed out that the 9 Price vaccine was quickly approved after benefiting from a number of new drug trials. In August 2015, the State Council issued the opinion on the reform of the examination and approval system for the review and approval of medical equipment for medical equipment. This document, called 44 article in the industry, opened the curtain on the reform of the Chinese drug trial system. In the following year, the priority review system, one of the supporting measures for drug trial reform, came into being. In 2017, the reform of the drug trial system was renewed again. The office of the Central Committee of the Communist Party of China and the office of the State Council formally issued the opinion on the reform of the examination and approval system for deepening the review and approval of the medical instruments and the innovation of medical equipment, and the policy of receiving clinical trial data from overseas. In December of that year, CFDA issued the technical guide for conditional approval of listing of clinical urgently needed drugs (Draft for solicitation). The document provides that innovative drugs for treatment of diseases that are seriously life-threatening and that there are no effective treatments can be approved on the basis of specific circumstances. Among them, according to the early or mid-term clinical trial data, it can reasonably predict or judge its clinical benefits and have obvious advantages over the existing treatment methods, allowing for approval before the completion of a confirmatory clinical trial is one of the conditions of conditional listing. At present, the technical guide is still in the stage of soliciting opinions, and the 9 Price vaccine has already benefited from it. After receiving the registration application for the import of the 9 price HPV vaccine, the State Drug Administration Bureau incorporated it into the priority review procedure, and communicated with the enterprise many times on the overseas clinical data and the safety monitoring after the market. Based on the data obtained from the previous 4 price vaccines, the clinical trial data from overseas were accepted and the clinical data from overseas were accepted. Bridging. In the shortest time, the import registration of products is conditionally approved. In April 29th, experts from the State Administration of drug supervision and Drug Evaluation Center, which is responsible for the approval of the 9 valent vaccine, disclosed more details on the website of the State Administration of drug supervision and administration. Conditional listing is facing the possibility of withdrawing the market Insiders worry that under the approval of rocket speed, how can we ensure the quality of vaccine? The State Drug Administration Bureau said that it will work with the national Wei Jian committee to strengthen supervision and inspection on the circulation, distribution and use of the vaccine, do a good job in monitoring the adverse reactions and ensure the safety of the public. At the same time, the State Administration of food and Drug Administration requested the company to develop risk management and control plans and carry out post marketing research as required. Moreover, as a conditional listing of the 9 valent HPV vaccine, it is also facing the possibility of being withdrawn from the market. According to the draft, the drug regulatory agency may revoke the conditional listing license that has been obtained in the following cases: a test that requires a product to predict the clinical benefit of the product fails to confirm the benefit; other evidence proves that the product is not safe or effective under the conditions of use; the applicant fails to perform the required approval to perform its duty. After the drug test, the applicant spreads false or misleading publicity materials related to the product. Although the market is on the market, but in the aforementioned agent, the 9 price of the vaccine mainland approved news, temporarily failed to give Hong Kong the upsurge of injections to cool, the current 9 Price vaccine is still not hit, so expensive. Because the mainland approved women under the age of 26, Hongkong has no age limit for the 9 price. Many overaged guests will still choose to go to Hongkong. The State Food and Drug Administration recommends that the public can choose different types of HPV vaccine according to their age and economic status. In response to the public concern about the formal sales time and pricing of the 9 price HPV vaccine, in May 2nd, merschon responded to the new Beijing report that it is working closely with the internal and external partners of the company to coordinate the resources and gradually promote the marketing process of the 9 price HPV vaccine in the mainland of China. Talking about the price of the vaccine, the director of Mercedes said the more HPV types included in the vaccine, the more complex the development and production process and the higher the cost. Therefore, the price of the 9 Price vaccine will be carefully evaluated for its cost-effectiveness, and the benefit and value of the vaccine will be measured. As soon as we have more information, we will release it in time. Beijing News reporter Xu Wen source: Beijing News Editor: Zhang Zutao _NT5054 The State Food and Drug Administration recommends that the public can choose different types of HPV vaccine according to their age and economic status. In response to the public concern about the formal sales time and pricing of the 9 price HPV vaccine, in May 2nd, merschon responded to the new Beijing report that it is working closely with the internal and external partners of the company to coordinate the resources and gradually promote the marketing process of the 9 price HPV vaccine in the mainland of China. Talking about the price of the vaccine, the director of Mercedes said the more HPV types included in the vaccine, the more complex the development and production process and the higher the cost. Therefore, the price of the 9 Price vaccine will be carefully evaluated for its cost-effectiveness, and the benefit and value of the vaccine will be measured. As soon as we have more information, we will release it in time.