In the current context of increasingly fierce competition in the global pharmaceutical industry, the research, development and launch of innovative drugs are of crucial importance for improving human health and promoting medical progress. On February 19, 2025, the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration delivered the "Legal Guidelines for the Launch of Innovative Drugs" to Novo Nordisk (Shanghai) Pharmaceutical Trading Co., Ltd. This measure, like a pebble thrown into a calm lake, has set off ripples in the pharmaceutical industry. It is not only of great significance to Novo Nordisk but also has a profound impact on the development of the entire pharmaceutical industry.
Novo Nordisk, a globally renowned multinational pharmaceutical company, has achieved remarkable results in the treatment fields of diabetes, obesity, etc. In recent years, with the acceleration of China's drug approval system, Novo Nordisk has successfully launched several innovative drugs in the Chinese market. Among them, the innovative drug semaglutide injection for long-term weight management has attracted global attention since its launch. According to Novo Nordisk's 2024 financial report, the global sales of semaglutide reached as high as 201.849 billion Danish kroner, and the Chinese market has become an important sales front for it.
However, the road to the launch of new drugs is not smooth. In July 2024, when the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration visited Novo Nordisk, it learned that the semaglutide injection faced many thorny problems in its launch plan. These problems involved key aspects such as market promotion, compliant operation, price setting, and protection of trade secrets. Facing the difficulties of the enterprise, the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration took active actions and came up with the idea of creating a targeted "guideline" for the enterprise.
Since then, the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration has embarked on a journey to solve the problems for the enterprise. They systematically sorted out the compliance requirements in the entire marketing chain in combination with the characteristics of the drugs and the market positioning, formulated compliance suggestions and risk warnings, and carefully crafted them into a "general template". Subsequently, the Law Enforcement Corps took this "general template" to the enterprise, listened to the ideas and opinions of the enterprise, and incorporated the "problems that the enterprise wants to solve" one by one. To ensure the professionalism and authority of the guidance suggestions, the Law Enforcement Corps also held several rounds of exchanges and discussions with relevant experts and lawyers, and comprehensively and deeply analyzed the risks that pharmaceutical enterprises may face during the launch of new drugs. After unremitting efforts, the "general template" was finally further materialized and successfully transformed into the "customized version" of the "Legal Guidelines for the Launch of Innovative Drugs".
This "customized version" of the guideline is like a detailed operation manual. It not only clearly tells enterprises what they "can do" and "cannot do" during the launch of innovative drugs but also provides many specific solutions on "what can be done and how to do it". For example, regarding the academic promotion issue that is widely concerned in the pharmaceutical industry, referring to relevant laws and regulations such as the "Anti-Unfair Competition Law", the "Compliance Guidelines for Pharmaceutical Enterprises to Prevent Commercial Bribery", and the "Trial Measures for the Filing Management of Pharmaceutical Representatives", the guideline clearly points out that pharmaceutical enterprises can carry out academic promotion based on their own needs, but they must correctly grasp the boundaries between academic activities and promotion behaviors. Specifically, first, it is necessary to strictly abide by relevant laws and regulations, compliance guidelines, and the relevant regulations of industry authorities, medical institutions, and healthcare professionals, and invite doctors to carry out academic activities; second, guide enterprises to strengthen the pre-, in-, and post-event approval processes of academic promotion activities in accordance with the principles of authenticity, rationality, and necessity; third, provide full-process guidance and assistance to pharmaceutical enterprises by unblocking communication channels.
For Novo Nordisk, this guideline is like a timely rain, providing a clear action guide for its promotion of innovative drugs in the Shanghai market. Ms. Ma, the legal affairs person in charge of Novo Nordisk (Shanghai) Pharmaceutical Trading Co., Ltd., said: "Based on its rich market supervision experience, the Shanghai Municipal Market Supervision Administration takes the initiative to serve enterprises, gives guidance and suggestions, allowing us to deeply feel the innovative services of the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration, the new measures to unblock the communication and cooperation between the government and enterprises, and the efforts to continuously optimize the business environment."
From a more macroscopic perspective, the impact of this incident on the pharmaceutical industry cannot be underestimated. As an important highland of China's biomedical industry, Shanghai's biomedical industry scale exceeded 933.7 billion yuan in 2024, with a year-on-year growth of 4.9%, approaching the trillion-yuan target. The "Legal Guidelines for the Launch of Innovative Drugs" provided by the Shanghai Municipal Market Supervision Administration for Novo Nordisk this time has set a benchmark for biomedical enterprises in terms of market promotion and compliant operation, and provided a valuable reference example. Wei Hao, the captain of the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration, said that this guideline is the first personalized attempt of the Law Enforcement Corps, taking an important step in deepening the service package system for key enterprises and opening up ideas for providing personalized and accurate services to more enterprises in the future. At the same time, considering the extensive demand of biomedical enterprises for marketing compliance suggestions in business scenarios such as commercial promotion, academic promotion, price policies, and distribution management, the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration will further streamline the existing version to form an industry-wide "general template". In subsequent visits and investigations, exclusive guidelines will be customized according to the specific problems of different enterprises to more accurately and efficiently respond to the service demands of enterprises.
In addition, as a multinational enterprise, Novo Nordisk has a wide global business layout and a huge compliance management system. This measure of the Shanghai Municipal Market Supervision Administration undoubtedly injects new vitality into its global compliance management system and provides valuable reference experience. This not only helps Novo Nordisk to further optimize its compliance management globally and enhance its corporate image but may also, to a certain extent, promote the communication and cooperation of the global pharmaceutical industry in terms of compliant operation, and promote the entire industry to develop in a more standardized and healthy direction.
The incident of the Law Enforcement Corps of the Shanghai Municipal Market Supervision Administration delivering the "Legal Guidelines for the Launch of Innovative Drugs" to Novo Nordisk is a vivid practice of the regulatory authorities and enterprises working hand in hand to promote the development of the pharmaceutical industry. It not only solves the practical problems of Novo Nordisk during the launch of innovative drugs but also sets an example for the compliant operation of the pharmaceutical industry, and brings new thinking and inspiration to the compliance management of the global pharmaceutical industry. It is believed that under the active guidance of the regulatory authorities and the active cooperation of enterprises, China's pharmaceutical industry will embrace a more standardized, innovative, and prosperous tomorrow.
