New Drug Administration Implementation Regulations Released: Allowing Innovative Drugs to be Produced in Segments, Accelerating the Market Launch of Good Medicines

On January 27, Premier Li Qiang of the State Council signed a State Council order to announce the revised Implementation Regulations of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Regulations"), which will take effect on May 15, 2026. The Regulations consist of 9 chapters and 89 articles, with the main revisions as follows:

First, improve the drug research and registration system. Support drug research and innovation oriented towards clinical value, encourage the research and development of new drugs, and support the clinical promotion and use of new drugs. Clarify the qualification recognition procedures for non-clinical safety evaluation research institutions for drugs, and refine the management requirements for drug clinical trials. Establish an accelerated procedure for drug market registration, clarify the drug re-registration process, and stipulate the mechanism for converting prescription drugs to over-the-counter drugs. Provide market exclusivity for eligible pediatric drugs and drugs for rare diseases, and implement data protection for drugs containing new chemical components. Refine the responsibilities of drug marketing authorization holders.

Second, strengthen drug production management. Strictly manage entrusted drug production, enforce the responsibilities of drug marketing authorization holders during entrusted production, and clarify the circumstances under which segmented production of drugs can be entrusted. Specify the management requirements for the production and sale of traditional Chinese medicine pieces and traditional Chinese medicine formula granules.

Third, standardize drug operation and use. Improve the management system for online drug sales, and enforce the responsibilities of third-party platforms for online drug transactions. Strengthen pharmaceutical management in medical institutions to ensure drug quality during the use phase. Clarify the approval process for the preparation of formulations in medical institutions, stipulate the conditions and procedures for the dispensing and use of formulations in medical institutions, and support the preparation of pediatric formulations to meet the medication needs of pediatric patients.

Fourth, enforce strict drug safety supervision. Clarify drug safety supervision and inspection measures. Refine the process for random inspection and testing of drug quality, stipulating that parties can apply for re-inspection if they have objections to the inspection results. Set strict legal responsibilities for violations.

The National Medical Products Administration stated that this is the first comprehensive revision of the Regulations in over twenty years since their implementation.

What are the key revisions of the Regulations? What impact will they have on China's pharmaceutical industry? What benefits will they bring to the public? A reporter from CCTV News exclusively interviewed relevant officials from the National Medical Products Administration for authoritative interpretations.

Zhang Qi, Director of the Policy and Regulation Department of the National Medical Products Administration, introduced that the Implementation Regulations of the Drug Administration Law are important supporting administrative regulations for the Drug Administration Law. The current Regulations were announced and implemented in 2002 and have undergone three amendments to individual provisions; this revision is the first comprehensive revision in 23 years since the implementation of the Regulations.

It is reported that compared to 23 years ago, there have been significant changes in the drug research, production, circulation, and use processes in China, and the legal and regulatory system needs to adapt to these changes and be revised and improved.

The current Regulations, which were announced and implemented in 2002, cover aspects such as the management of drug production enterprises, management of drug operation enterprises, pharmaceutical management in medical institutions, drug management, drug packaging management, drug pricing and advertising management, drug supervision, and legal responsibilities.

Zhang Qi stated that the upper-level law of the Implementation Regulations of the Drug Administration Law, the Drug Administration Law, was comprehensively revised in 2019, and this comprehensive revision of the Regulations has modified over 90% of the provisions, with the exception of the first article, which cites the Drug Administration Law as the legislative basis and has not been modified; all other provisions have been adjusted or revised It is understood that China launched the reform of the drug review and approval system in 2015, and comprehensively revised the Drug Administration Law in 2019, introducing the drug marketing authorization holder system, encouraging innovation, and strengthening the supervision of the entire lifecycle of drugs.

Zhang Qi stated that this revision of the regulations refines the institutional measures of the Drug Administration Law, elevating the mature experiences from recent years of drug regulatory reform to the level of law. The current regulations focus on the management of drug production and operation enterprises, while the revised version shifts to center around the drug marketing authorization holders, implementing the primary responsibility of the holders and strengthening strict supervision throughout the entire lifecycle of drugs.

Lan Gongtao, deputy director of the Drug Registration Management Department of the National Medical Products Administration, introduced that this revision of the regulations clearly supports the research and creation of new drugs guided by clinical value, and for the first time introduces a market exclusivity system for pediatric drugs and drugs for rare diseases, promoting drug research and better serving patients' clinical medication needs.

Li Jiangning, director of the Drug Supervision Management Department of the National Medical Products Administration, stated that the regulations emphasize strict supervision while also paying more attention to ensuring that the public has access to medications and can obtain them conveniently. The specific requirements for the supervision of entrusted drug production, online drug sales, and the cultivation of traditional Chinese medicine materials as well as the production of traditional Chinese medicine pieces have been further refined.

Encouraging Drug Research and Innovation, Four Accelerated Approval Channels Written into Law

This is the first comprehensive revision in 23 years, differing from the previous three "minor adjustments." Journalists noted that encouraging innovation is a prominent feature of this revision. Supporting the research and creation of new drugs guided by clinical value, improving the quality and efficacy of generic drugs, is clearly stated in the general principles of the newly revised regulations.

Zhang Qi introduced that in terms of system design, the regulations clearly stipulate a fast-track review channel for drug marketing, accelerating the market entry of new and good drugs and shortening the time patients wait for medications.

Lan Gongtao stated that the regulations formally clarify four accelerated approval channels: breakthrough therapy drugs, conditional approvals, priority reviews, and special approvals, in administrative regulations.

It is reported that China implemented the Drug Registration Management Measures in 2020, establishing these four accelerated approval channels for the first time. As of December 2025, a total of 395 cases have been included in the breakthrough therapy drug program, 158 cases have received conditional approval for marketing, and 508 varieties have been included in the priority review and approval program, accelerating the market entry of a large number of clinically needed drugs to meet patients' clinical needs. Statistics from the National Medical Products Administration show that the average review time for innovative drugs in China has been shortened by 25% compared to 2018.

Since the 14th Five-Year Plan, as of December 2025, the National Medical Products Administration has approved the marketing of 230 innovative drugs, 449 pediatric drugs, and 170 drugs for rare diseases.

Zhang Qi stated that the newly revised regulations clearly stipulate that research data obtained overseas that meets the requirements can be used for drug registration in China, promoting the early market entry of global innovative drugs in China.

Protection of Experimental Data + Market Exclusivity Period, Protecting Drug Intellectual Property

Journalists observed that a major focus of this revision of the regulations is to systematically strengthen the protection of drug intellectual property, encouraging enterprises to continue research and innovation.

Lan Gongtao introduced that the newly revised regulations expand the drug experimental data protection system, for the first time introducing a drug market exclusivity period system, strengthening the protection of drug intellectual property

• During the data protection period, innovative pharmaceutical companies can obtain reasonable profits, which helps to sustain research and development of innovations;
• After the data protection period, generic drug companies can simplify the market application process by utilizing the data from original research drugs, which helps to lower drug prices and improve public access to and affordability of medications.

According to reports, this revision of the regulations fully considers the medication rights of special groups and expands the drug market exclusivity system to include medications for rare diseases and pediatric medications.

• A market exclusivity period of no more than 2 years will be granted to eligible pediatric medications;
• A market exclusivity period of no more than 7 years will be granted to eligible rare disease medications.

It is understood that granting a certain market exclusivity period for medications for rare diseases and pediatric medications is a common practice internationally. Currently, China grants a certain market exclusivity period to eligible generic drugs that successfully challenge patents, striving to find a common ground between drug innovation and the benefits of generics for the public.

Lan Gongtao stated that establishing a drug trial data protection system and a market exclusivity system will help promote the transformation of China's pharmaceutical industry from a "generic-focused" strategy to an "innovation-driven" strategy.

Online drug sales reach 80 billion, regulations clarify platform responsibilities and requirements for the first time

The reporter noted that this comprehensive revision of the regulations also focuses on the supervision of drugs after they are marketed. For instance, buying drugs online has become increasingly popular due to its convenience, even becoming the preferred method for some individuals. Ensuring the safety of these medication needs is a key focus of regulatory authorities and an important aspect of this regulatory revision.

According to reports, the newly revised regulations clarify that the "responsibility of the enterprise, platform oversight, and full-process control" applies to online drug trading platforms, specifying and solidifying the responsibilities and specific requirements of these platforms in internet drug sales, as well as clarifying categories of drugs that are unsuitable for online sales.

Li Jiangning introduced that the newly revised regulations further detail the relevant obligations of the platforms, requiring them to establish dedicated institutions, equip specialized personnel, and create corresponding institutional systems to manage the merchants on the platform and the drug trading activities that occur there. For example, platforms must strictly review the qualifications of merchants selling drugs, carefully check the relevant information of drugs sold on the platform, and retain related management records.

In addition, the newly revised regulations for the first time clearly state "encouragement for the implementation of quality management standards for traditional Chinese medicine materials," in conjunction with the implementation of GAP for traditional Chinese medicine materials, to standardize and enhance the development level of traditional Chinese medicine materials from the source.

Li Jiangning stated that improving the quality of traditional Chinese medicine materials from the source will further strengthen the supervision of traditional Chinese medicine decoction pieces production. This regulation for the first time clarifies at the legislative level that provincial local governments should formulate plans based on actual conditions, encouraging the implementation of quality standards for traditional Chinese medicine production to further enhance the standardization and normalization of the cultivation and breeding of traditional Chinese medicine materials.

It is understood that this revision of the regulations also for the first time clarifies the standard requirements for the production of decoction pieces used in the production of traditional Chinese medicine, as well as the relevant production requirements for enterprises.

Li Jiangning introduced that as of now, there are 475 traditional Chinese medicine planting bases in China that meet the requirements of quality management standards for traditional Chinese medicine, with a planting area exceeding 1.24 million acres, capable of providing over 100 types of traditional Chinese medicine materials for use by traditional Chinese medicine production enterprises and decoction piece production enterprises

"Active Regulation": Allowing Segmented Commissioned Production Written into Regulations

Reporters carefully reviewed the newly revised regulations and found that a "flexible yet firm" approach to the regulation of listed pharmaceuticals in China fully unleashes the innovative development vitality of the pharmaceutical industry. For example, it clearly states: allowing segmented commissioned production of pharmaceuticals and clarifying that commercially scaled batch pharmaceuticals can be marketed are key highlights of this revision.

Li Jiangning introduced that under the traditional pharmaceutical production model, the holder of the drug marketing authorization typically has to complete all production processes within a single production site or facility. In recent years, some innovative drugs with special structural compositions have emerged, requiring various production technologies and specialized production equipment to complete their manufacturing. For these types of drugs, the traditional production model has become inefficient in ensuring their production. Therefore, this revision of the regulations explicitly allows for segmented commissioned production for such drugs.

It is reported that the National Medical Products Administration (NMPA) will clearly include innovative biological products and clinically needed biological products in the pilot scope of segmented production in 2024, exploring segmented production models to accelerate production efficiency and ensure supply.

Li Jiangning mentioned that starting in 2024, the NMPA will begin pilot segmented production for 15 innovative drugs from 10 drug marketing authorization holders in six provinces and cities, including Beijing, Tianjin, Shanghai, and Jiangsu. Through the evaluation of the pilot effects of segmented production and the summary of experiences, it has been formally clarified in the regulations that these innovative drugs, which have special requirements for production processes and equipment, can be produced in a segmented commissioned manner, while also specifying the production quality requirements for these drugs to ensure that the entire production process continuously complies with legal requirements