Enterprises find a fault, and the queue time is shortened from 2 hours to 20 minutes. This is an unexpected surprise for the enterprises after the trial operation of the online and offline "please find fault" consultation channel in Pudong New Area, Shanghai. According to the opinions of enterprises, Pudong Administrative Service Center adjusted the window settings.
"The government is no longer a manager, but looking for the market, looking for citizens to learn from their teachers and transforming government functions." Jiang, deputy director of the Pudong New Area Government Office and director of the administrative service center, said.
As the first pilot free trade zone in China, Shanghai Free Trade Zone, in addition to the earliest start and comprehensive and in-depth reform, has a remarkable feature, that is, "transforming the first-level government according to the concept of free trade zone". In the past four years, Shanghai Free Trade Zone has taken the lead in establishing and perfecting an institutional system that is in line with international rules, oriented by market players and based on the transformation of government functions.
Among them, the reform of the drug registration management system initiated by Shanghai Free Trade Zone-the drug listing license holder system can be described as a pioneering work for biomedical innovative enterprises to achieve "overtaking in corners".
Spend less money, save time, and R&D enterprises go into battle lightly.
In March this year, the new drug project for treating diabetes developed by Hualing Medicine in Zhangjiang District of Shanghai Free Trade Zone was approved as a pilot product of the drug marketing license holder system, which means that the company does not need to build its own factory for production, saving 65.438+0.5 billion yuan at once. "Not to mention, I also got time that money can't buy." Chen Li, the general manager of the company, can't hide his excitement.
Drug marketing license holder system refers to the system in which drug research and development institutions, scientific researchers, pharmaceutical production enterprises and other subjects with drug technology apply for drug marketing license and obtain the approval documents of drug marketing license, and assume the main responsibility of drug quality throughout their life cycle.
Before the pilot, China's drug registration system was a management mode of "bundling" marketing license and production license, that is to say, drug marketing license was only issued to production enterprises with Drug Production License, while drug research and development institutions and researchers were not qualified to independently obtain drug marketing license.
"The drug marketing license holder system is actually an international practice." Shen Jianhua, deputy director of the Pudong New Area Market Supervision Bureau, said that the current system has caused the phenomenon that R&D institutions can't afford to build factories, production enterprises can't get enough to eat, and the subject responsible for drugs is unclear. The government regulatory authorities are also tired of the low-level examination and approval of repeated declarations, and cannot form effective supervision over the whole life cycle of drugs.
20 15, 1 1 With the joint efforts of Shanghai and relevant departments, the National People's Congress Standing Committee (NPCSC) authorized the State Council to carry out the pilot system of drug marketing license holders in 10 provinces and cities, and the marketing license holders and production license holders were finally "loosened".
As soon as the pilot reform of the drug listing license holder system was launched, Hualing Medicine became the first batch of pilot enterprises. They have established a cooperative relationship with Shanghai Hequan Pharmaceutical Co., Ltd. and Shanghai Disuo Biomedical Co., Ltd., and "go into battle lightly".
Promote the formation of a new model of drug supervision
In May this year, the Boehringer Ingelheim biopharmaceutical production base in China, which was jointly built by German pharmaceutical giant Boehringer Ingelheim Company and Shanghai Zhangjiang Biomedical Base Development Co., Ltd., was officially completed and put into use.
This is the first and only biopharmaceutical base with international standards established by multinational pharmaceutical companies in China, and it is one of the first batch of pilot projects for contract production of biopharmaceuticals in China. Luo Jiali, general manager of Boehringer Ingelheim Biopharmaceutical (China) Co., Ltd. said: "This production line is the largest disposable bioreactor in the world with an investment of 400 million yuan."
The investment confidence of enterprises also comes from the pilot system of drug listing license holders in Shanghai Free Trade Zone.
Different from the small molecular chemicals developed by Hualing Pharmaceutical, Boehringer Ingelheim's customers are all biomedical research and development institutions, and the cost of biomedical production lines is higher and the investment is greater. Most R&D enterprises are light-asset enterprises focusing on talents. It's incredible to spend so much money to build a factory at once. So in this field, the phenomenon of "selling young crops" is very common, that is, after the research and development results come out, they can't produce them themselves, so they can only make a small profit and sell them, watching the huge profits of new drugs fall into other people's pockets.
With Boehringer Ingelheim's biopharmaceutical production base in China, this phenomenon can be avoided. "R&D institutions can use our high-quality factory as long as they pay the commissioned production fee." Luo Jiali said.
In addition to making R&D more closely related to production, "there is also a complete person in charge of drug quality." Shen Jianhua said, "We can also take the drug marketing license holder as the leader, and form a new model of' government-led and multi-participation' drug supervision through their participation and supervision in the whole life cycle of drugs."
Simplify administration and decentralize power, combine decentralization with management, and optimize services.
The institutional innovation promoted by the Shanghai Free Trade Zone has now shown a reform dividend throughout the country. By the end of May this year, the State Food and Drug Administration of the United States had accepted 38 1 application for pilot registration of drug marketing license holders.
"In the next step, we will further deepen decentralization, integrate management and optimize services," said Weng Zuliang, member of the Standing Committee of Shanghai Municipal Committee, secretary of Pudong New Area Party Committee and director of Shanghai Pilot Free Trade Zone Management Committee.
In terms of "liberalization", we will focus on deepening the reform of "separation of licenses", strive to incorporate all market access matters and all 44 1 district administrative examination and approval matters into the reform, and take filing and informing commitments as the main reform direction. The results of the first batch of 1 16 examination and approval reforms have been replicated and extended to other pilot free trade zones with the consent of the State Council in September this year, and the second batch of reforms has also started.
In terms of "management", we will focus on implementing the licensing mechanism of "double notification, double feedback and double tracking" and the regulatory coordination mechanism of "double randomness, double evaluation and double publicity", and strive to extend to all areas involved in examination and approval supervision in the new district. At present, the "six pairs" have achieved full coverage of Pudong New Area's economic field 2 1 regulatory authorities, and achieved full coverage of 108 regulatory industries and fields before the end of the year.
In terms of "service", we will focus on promoting "three projects", namely "all-netcom" for enterprises, "all-regional communication for personal community affairs" and "all-regional communication for government information". At present, 104 enterprise access rights have all been "completed at one time" and 74 have been "processed online"; Basically realize the whole district 17 1 individual community affairs; In 2020, government information will be "shared by the whole region".
"It is the mission of the reform of Shanghai Free Trade Zone to achieve more flexibility, better management and better service through the transformation of government functions." Shen Jianhua said that setting more road signs for Shuangchuang without roadblocks has become a * * * knowledge of the regulatory authorities of the Free Trade Zone.
It will get better and better.