Promoting over 300 reform experiences nationwide and leveraging the role of institutional innovation as a "test field"

Release time:Apr 16, 2024 21:08 PM

In 2021, the 38th meeting of the 15th Standing Committee of the Municipal People's Congress voted to pass the "Regulations on Promoting the Construction of Zhangjiang Biomedical Industry as a New High Ground in Pudong New Area, Shanghai". This local industrial legislation provides strong legal support for further promoting the construction of an innovative highland for the biopharmaceutical industry in the Zhangjiang area of the Shanghai Pilot Free Trade Zone. Several biopharmaceutical companies have stated that the legislation presents characteristics such as comprehensive coverage, fast speed, and strong intensity, which meets the needs of the industry and solves the problems of long entry cycles for pharmaceutical devices and the need for approval for some overseas new drugs entering the market.

The introduction of regulations has a significant driving effect on the biopharmaceutical industry in Zhangjiang. In 2022, the total operating revenue of Zhangjiang Science City's biopharmaceutical industry was 132 billion yuan, a year-on-year increase of 7.5%, accounting for about 1/6 of the city's total. This is a microcosm of the Shanghai Free Trade Zone's promotion of technological innovation and industrial development through institutional innovation. Looking back at the past 10 years, the Shanghai Pilot Free Trade Zone has accumulated over 300 reform experiences that have been replicated and promoted nationwide at different levels and fields, fully playing the role of a "test field" for institutional innovation.

Creating an innovative development environment with international competitiveness

At the beginning of the year, a biotechnology company focused on cell immunotherapy, Pharmaceuticals, completed the risk assessment process required for the import of 142 bottles of human AB serum. Since the Zhangjiang Free Trade Zone took the lead in carrying out the pilot program for facilitating the import of biopharmaceutical special items in the country, Yaoming Junuo has recently been included in the "whitelist" of enterprises.

With the rapid development of biotechnology, the demand for special items for research and development, as well as the need for fast customs clearance upon entry, is increasing among enterprises. In December 2019, a joint supervision platform for the safety of special items entering and exiting Zhangjiang was established. Through the joint supervision mechanism, various links, full process supervision, and comprehensive evaluation were carried out on the risk control and reasonable use needs of special items intended for entry and exit. Based on the comprehensive evaluation opinions of the joint supervision mechanism, Shanghai Customs optimizes the approval process and accelerates the processing of customs clearance procedures.

This pilot program has created a favorable environment for the development of Zhangjiang's biopharmaceutical industry, and the pilot program for facilitating the entry and exit of special items has also been replicated and expanded throughout the city. "We need to import a certain amount of human AB serum every year for scientific research, and the stable supply of materials is directly related to the research and development process of cell therapy drugs. In the past, the time required to import special items of blood based biopharmaceuticals was uncertain, and with the joint supervision mechanism, the pre import evaluation process was shortened, customs clearance efficiency was improved, and the company was more focused on research and development with peace of mind," said the relevant person in charge of Pharmaceuticals.

Since its establishment, the Zhangjiang Free Trade Zone has created an innovative development environment with international competitiveness through institutional innovation, striving to become an important source of new scientific discoveries, technological inventions, and industrial directions. Innovative measures such as promoting the pilot implementation of the MAH system for drug market authorization holders and exploring the establishment of the first customs supervision site for air cargo outside the airport area in Shanghai have accelerated the original innovation and industrialization process of Zhangjiang Biopharmaceuticals, serving a group of R&D and innovative enterprises such as Yingcai, Minimally Invasive, and Intuitive Fosun.

Promoting high-level opening up of finance as a pilot

At this year's Lujiazui Global Asset Management Summit, the main leaders of the world's top ranked asset management institutions attended one after another, all proposing to accelerate the deployment of foreign-owned public funds in China. The best choice for domestic and foreign financial institutions to establish themselves in China and allocate global resources is undoubtedly the Lujiazui Free Trade Zone.

Taking the implementation of the "Further Deepening the Reform and Opening up Plan of China's Pilot Free Trade Zone" as the starting point, the Lujiazui Free Trade Zone has seized the opportunity of expanding the opening up of the financial industry, promoted high-level opening up of finance, and has become the region with the most complete domestic financial factor market, the most concentrated financial institutions, the most active financial transactions, and the richest financial talents, helping Shanghai International Financial Center rise to third place globally.

For foreign investment in the financial industry, Lujiazui is exploring the implementation of a pre admission national treatment plus negative list model, gathering 122 asset management companies from 13 countries and regions. Lujiazui has also achieved breakthroughs in fundraising, investment, and innovative business in asset management institutions, including promoting the China Securities Regulatory Commission's State Administration of Foreign Exchange to issue policies to expand the scope of foreign private equity fundraising, and promoting the Shanghai headquarters of the People's Bank of China to expand the scope of foreign private equity investment.

Based on regional characteristics and functional positioning, the Lujiazui area continues to make efforts in attracting institutions, deepening cooperation, optimizing ecology, and exploring innovation, promoting the rapid development of regional professional service industry and enhancing global resource allocation capabilities.

In December 2014, the Shanghai Municipal Bureau of Justice officially announced the "Implementation Measures for the Exchange of Lawyers as Legal Advisers between Chinese and Foreign Law Firms in the China Pilot Free Trade Zone" and the "Implementation Measures for the Joint Venture of Chinese and Foreign Law Firms in the China Pilot Free Trade Zone", allowing mainland law firms and foreign law firms to conduct business cooperation through "mutual assignment of lawyers as legal advisors" and "joint venture".

As of now, the offices jointly operated by Fenxun, Beck&McKinsey, Yingtai, and Xia Liwen, eight Chinese and foreign law firms, are all located in Lujiazui, which has become one of the important achievements in the expansion and opening up of the free trade zone. The Lujiazui area has also developed into an important gathering place for the domestic professional service industry, gathering more than 3000 various professional service institutions, including 6 of the top 10 law firms globally, 5 of the top 10 law firms nationwide, and more than half of the city's law firm revenue exceeding 1 billion yuan. There are also 3 out of the four major clubs globally, 11 out of the top 20 law firms nationwide, and 4 out of the five major real estate brokerage companies worldwide, all of which have institutions in Lujiazui.

Establishing a reform coordination system that adapts to national strategies

It is worth mentioning that the Shanghai Pilot Free Trade Zone focuses on "streamlining administration and delegating powers, combining decentralization with management, and optimizing services", accelerating the profound transformation of government functions, comprehensively promoting innovation in government management systems and mechanisms through information technology, and establishing a reform coordination system that is in line with national strategic requirements.

It used to take several months to open a cinema, but in Pudong, after the "one industry, one certificate" reform, it now only takes 12 days. The Shanghai Free Trade Zone has comprehensively promoted the implementation of the "one industry, one certificate" reform, established a cross national, municipal, and district industry licensing system, undertaken 25 national level powers, and implemented all 31 pilot industries. By the end of 2022, more than 3200 industry comprehensive licenses have been issued.

The Shanghai Free Trade Zone is also exploring the establishment of a market admission commitment system based on the integrity of market entities, and the scope of reform implementation is expanded to 22 industries. Continuous supervision during and after the completion of the project, with credit based hierarchical and classified supervision covering 57 major industry sectors in Pudong.

The regulations of Pudong New Area have established a legal guarantee system for the high-level reform and opening up of the Shanghai Free Trade Zone. As of now, a total of 18 regulations have been issued in the fields of green finance, new research and development institutions, and intelligent connected vehicles in Pudong New Area; 16 management measures have been issued in areas such as commercial mediation, characteristic industrial parks, and existing industrial land, effectively solidifying the leading and iconic institutional innovation achievements of the Shanghai Free Trade Zone.

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