30 working day review channel will be opened

June 18, 2025  Source: drugdu 81

 

Innovative drug payment breaks through the ten-year road from "payment desert" to "trillion dollar blue ocean". Pharmaceutical companies are at the moment of innovation: giants turn around, innovators seek gold

On June 16th, the National Medical Products Administration released the "Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"), which marks the beginning of a transformation that may reshape the development pattern of innovative drugs in China - the clinical trial review and approval cycle for core innovative drug varieties is expected to be compressed to 30 working days.

Clinical trials are an important part of innovative drug development. The optimization of the clinical trial review and approval pilot for innovative drugs can significantly improve research and development efficiency, and is the key to China's move towards becoming a global hub for innovative drug development.

According to the draft for soliciting opinions, the 30 day channel for drug clinical trial application review and approval supports national key research and development varieties, encourages global early synchronous research and development and international multi center clinical trials, and serves clinical urgent needs and the development of the national pharmaceutical industry. Qualified drugs should be innovative drugs in Class 1 of traditional Chinese medicine, chemical drugs, and biological products, mainly including three categories.

One is the key innovative drugs supported by the state. Key innovative drug varieties with significant clinical value that have received support from the national policy system for the development of innovative drugs across the entire chain.

The second is the varieties selected for the Children's Drug Starlight Program and Rare Disease Care Program of the Drug Evaluation Center of the National Medical Products Administration.

Thirdly, globally synchronized research and development of varieties. The Phase I and Phase II clinical trials, as well as the Phase III international multicenter clinical trial developed globally, and the international multicenter clinical trial led by major Chinese researchers.

Jin Chunlin, director of the Shanghai Health and Health Development Research Center, told 21st Century Business Herald reporters that shortening the approval time from the usual 60 working days to 30 days, and even to 18 days in Beijing and other regions, will significantly improve the efficiency of clinical trial initiation and provide strong support for enterprises to accelerate their research and development pace and seize the global market; At the same time, it will effectively reduce research and development costs and risks, reduce waiting time for enterprises, save funds and registration time costs, and ultimately significantly enhance the international competitiveness of China's pharmaceutical industry. This move further optimizes resource allocation and is conducive to guiding high-quality resources to be concentrated in high-level institutions.

A pharmaceutical industry analyst from a securities firm also told 21st Century Business Herald reporters that the initiation of clinical trials is one of the longest stages in new drug development, and the 30 day review is a qualitative leap compared to the conventional process (the average approval time for innovative drug clinical trials in 2023 is about 85 days). Taking a typical tumor drug as an example, if its Phase III multicenter clinical trial (MRCT) saves 55 days in approval, the market launch time is expected to be advanced by more than six months.

In addition, 'global synchronous research and development' has been clearly included in the priority channel, which will greatly enhance China's attractiveness as a key site for international multicenter clinical trials. Under the new policy, multinational pharmaceutical companies are more motivated to include China in early global plans, enabling Chinese patients to use new drugs earlier, "the analyst said.

Innovative research and development acceleration

As a science, drug review is constantly developing and optimizing technical specifications, inspection and evaluation techniques, and technical standards through a series of innovative regulatory tools, standards, and methods, in order to effectively address prominent issues affecting drug innovation, quality, and efficiency.

In 2024, the National Medical Products Administration issued a notice on the pilot work plan for optimizing the evaluation and approval of clinical trials for innovative drugs, which clearly pointed out the need to optimize the evaluation and approval mechanism for clinical trials of innovative drugs, strengthen the main responsibility of drug clinical trial applicants, enhance the risk identification and management capabilities of relevant parties for clinical trials of innovative drugs, explore the establishment of a comprehensive work system and mechanism to improve the quality and efficiency of drug clinical trials, and achieve the completion of evaluation and approval of clinical trial applications for innovative drugs within 30 working days, shortening the start time of trials.

At that time, many industry insiders believed that this milestone decision not only marked another profound change in China's drug regulatory system, but also gave wings to China's pharmaceutical industry to soar, indicating that China's innovative drug research and development will enter a new era of "acceleration".

The draft for soliciting opinions emphasizes the main responsibility of applicants included in the 30 day channel: before submitting the clinical trial application, they have already cooperated with the drug clinical trial institution to simultaneously carry out project approval and ethical review; Capable of conducting risk assessment and management in the development process that is suitable for the risks of the declared product, and committed to initiating clinical trials within 12 weeks after approval (with the first participant signing an informed consent form).

The draft for soliciting opinions shows that the application materials for the review and approval of innovative drug clinical trials included in the 30 day channel shall be formulated and published by the Drug Evaluation Center of the National Medical Products Administration. If the application included in the 30 day channel cannot be reviewed and approved within 30 days due to technical reasons such as the need to convene an expert meeting, the review center shall promptly inform the applicant, and the subsequent time limit shall be executed according to the 60 day implied license.

Regarding the highlights of this draft for soliciting opinions, Jin Chunlin believes that firstly, the applicable standards for the three priority review channels have been clarified, covering innovative drugs supported by the state, children's drugs, rare disease drugs, and globally synchronized research and development varieties, and providing more targeted support for international multicenter clinical trials led by domestic researchers; Secondly, a dynamic risk management mechanism has been established, requiring applicants to demonstrate the compliance of the evaluation agency during the application process and commit to initiating trials within 12 weeks to prevent delays in execution after approval; Once again, a flexible review mechanism has been introduced, which automatically transfers to a 60 day grace period for cases where the review exceeds the deadline due to technical factors; In addition, the scope of application has been expanded, and cutting-edge therapies such as cell and gene therapy have not been excluded, providing policy support for these fields.

"In particular, encouraging Chinese researchers to lead MRCT is an important springboard for China's pharmaceutical R&D strength to" go global ", which can further enhance the international voice of local innovative drugs. ”The aforementioned analyst believes that when it comes to enterprises, innovative pharmaceutical companies such as BeiGene, Xinda Biotech, and Yasheng Pharmaceuticals are all expanding their global presence. If their independently developed Class 1 new drugs belong to the national key support direction or have global potential (especially in the early pipeline), they can use this channel to significantly accelerate their development.

The above analysts said that the purpose of this release of the Draft is to strengthen the communication between local innovative pharmaceutical enterprises and regulators, actively incorporate innovative achievements into the national support system, further optimize the global clinical development strategy, and strive to promote the "first launch in China" or "global synchronization" of innovative achievements.

From acceleration to quality improvement

Policies are not unconditional 'green lights', and they also put forward higher requirements for the capabilities of enterprises.

The draft for soliciting opinions this time pays special attention to "niche" diseases, clearly highlighting pediatric drugs and rare disease drugs, which is conducive to addressing the large number of unmet clinical needs among them. The inclusion of Starlight Plan and Care Plan varieties in the fast track is a key incentive to address the pain point of "insufficient research and development power".

According to data from the Rare Disease Information Network, only about 10% of the over 800 rare disease drugs that have been approved for market worldwide are in China. According to the "First Batch of Rare Disease Catalogue" and "Second Batch of Rare Disease Catalogue" released by the National Health Commission and other departments, 70% of rare diseases in China have not yet had effective therapies on the market. Among them, 33 rare disease patients still face the dilemma of "having drugs overseas but not domestically". Previously, there was a lack of systematic policy support in the development of new drugs for rare diseases that had no drugs worldwide, and the related research and development of new drugs was scarce in China.

Xue Qun, founder and chairman of Beihai Kangcheng, pointed out to 21st Century Business Herald reporters that, taking Gaucher's disease as an example, there are currently three enzyme replacement therapies and one small molecule drug available in the global market for this disease, including Sanofi's Cerdelga and Cerezyme, as well as Aegestat, with annual sales totaling over 1 billion US dollars. However, the vast majority of patients with Gaucher's disease worldwide have not yet received treatment, with only 5000 to 8000 patients receiving continuous treatment. This also means that the market still needs to be explored.

Xue Qun believes that for rare disease drug development companies, the primary task is to establish a sustainable business model, "first and foremost, profitability and survival, creating returns for investors. However, while rare disease drug development companies achieve financial success, they can also make significant contributions to the rare disease ecosystem and patient rights

When local pharmaceutical companies venture into these "niche" disease fields, they not only solve simple medical problems, but also explore a sustainable and humane path in the delicate balance between business ethics and social responsibility. The promotion of this draft for soliciting opinions may redefine the value coordinates of Chinese rare disease research and development innovative pharmaceutical companies.

In addition to refining the disease field, the "12 week launch" mentioned in the draft for soliciting opinions is also a hard commitment, which can avoid resource idle and force enterprises to upgrade their clinical operation capabilities. The ability to coordinate institutions, ethics, contracts, and initiate training within three months is a major test for enterprises. However, this also provides development opportunities for top CROs (WuXi AppTec, Tiggo Pharmaceuticals) and SMO companies with efficient execution capabilities.

The '12 week commitment' also means that companies need to strengthen risk management, requiring them to establish a strong drug alert and risk control system that matches the acceleration. The aforementioned analyst emphasized that while pursuing efficiency, companies should also reserve necessary review space for varieties that require in-depth evaluation to ensure quality and safety bottom lines.

Jin Chunlin also pointed out that in the process from pilot to comprehensive promotion, it is necessary to pay attention to the risks and challenges behind it: firstly, it is necessary to improve the risk control ability. In the pilot stage, applicants are required to have rich experience in drug vigilance and submit a risk management plan. After comprehensive promotion, it is necessary to strengthen the early communication and mechanism training of the drug review center; Secondly, to address the imbalance between regional and institutional capabilities, pilot programs should be limited to areas with mature conditions, and nationwide promotion should avoid the resource siphon effect caused by insufficient institutional capabilities in the central and western regions.

In addition, it is necessary to adhere to the mechanism for preventing conflicts of interest, ensure that the delegation of review power does not lead to local protectionism, and establish a unified national regulatory system. It is also necessary to strengthen relevant supporting policies, such as piloting drug supplementary applications, to address potential bottlenecks after innovative drugs are launched, "said Jin Chunlin.

By editor
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