Interpretation of the New "Regulations for the Implementation of the Drug Administration Law"!

Article source: GMP Office

Author: Compliance Group

The revision process of the Implementing Regulations of the Drug Administration Law and social responses

On May 9, 2022, the draft of the Implementing Regulations of the Drug Administration Law was first made public for comments, receiving over 5,000 feedbacks. Since then, despite numerous revisions and opinion integrations, and minor modifications to some administrative regulations in 2024, the complete revised version has yet to be released. In a training session in 2022, the National Medical Products Administration presented the progress of the revision, indicating that the collection and adoption of opinions have reached a certain stage. However, due to reasons such as the rapid changes in Chinese regulations and the situation of the pharmaceutical industry, the revision work has been postponed. It is expected that the regulation will be made public for comments again in the second half of 2025 and be promulgated and implemented the following year.

Analysis of the Internationalization Trend of Drug Management Regulations and Their Science

With the promulgation of the Drug Administration Law and the Vaccine Administration Law, emphasis has been placed on the links covered by drug administration, including research and development, production, operation, use and supervision and management. The authority of the Drug Administration Law, as well as the scientific and international trends in drug administration. The significance of adopting new methods, new tools, new standards and new thinking, and this is an irreversible direction of development. For practitioners, it is necessary to enhance their learning of scientific and international standards, such as PIC/S and ICH guidelines, to adapt to the development needs of the industry.

What are the main differences between the new and old versions of the Implementing Regulations of the Drug Administration Law? What is the process of soliciting opinions on the implementation regulations?

Compared with the old version, the new draft of the Implementing Regulations of the Drug Administration Law (2022 and 2025) not only doubles the number of articles from 80 to 181, but also makes adjustments and supplements in specific content. After the implementation regulations were first made public for comments late at night on May 9, 2022, they received a strong social response, with over 5,000 feedbacks received. Since then, although there have been minor revisions, the overall revision work is still ongoing and it is expected that public opinions will be solicited again this year, and it will be officially released and implemented next year.

What are the core contents of the revision of the Implementing Regulations of the Drug Administration Law?

The core contents include: First, the main basis for formulation is the Drug Administration Law and the Vaccine Administration Law; Second, it emphasizes that drug management covers all links from research and development, production, operation, use to supervision and management, and is comprehensive and authoritative. Third, it is required to follow scientific and ethical principles and enhance the scientific and international level of drug supervision. Fourth, the government should assume the political responsibility of ensuring the supply and safety of drugs, while also paying attention to social equity and the burden on patients.

Will the number of pharmaceutical enterprises in China drop significantly to two or three thousand in the next 50 years?

No, at least this situation won't occur within 50 years. Due to employment pressure and social demand, the government will take measures to ensure that the number of enterprises does not sharply decrease because of market competition. However, as time goes by and international competition intensifies, such as competition with countries like India, it is estimated that by 2011, there may only be two or three thousand pharmaceutical enterprises left in China.

Related to drug research and development and registrationHow are the regulations stipulated?

According to the regulations, regardless of whether it is domestic or foreign research and development activities, as long as they aim at listing in China, they must be carried out in accordance with China's requirements. This means that even the research and development work carried out in New Jersey, USA, must comply with Chinese regulations and standards. Meanwhile, the intensity of China's verification will be adjusted according to the actual situation. For instance, a new verification document was issued on December 20, 2021. For overseas enterprises, the regulations on the overseas inspection and management of drugs and medical devices apply.

How is China's drug regulatory system constructed and implemented in accordance with ICH guidelines?

China is fully moving towards the International Council for Harmonisation of Pharmaceutical Technical Regulations (ICH) and has established guiding principles at the CDE and CFDI centers of the National Medical Products Administration, which are respectively responsible for research and development and review, verification and inspection, etc. Meanwhile, as the highest representative of technical standards, the Chinese Pharmacopoeia has initiated the related work of ICHQ4.

What is the situation regarding the listing channels and policies for innovative drugs?

At present, China's listing channels, including breakthrough therapy drugs, conditional priority review, special approval and other systems, are already very sound, and the approval progress is on par with that of the United States in the global approval of innovative drugs. In addition, regarding drug standards, three major categories - national drug standards, drug registration standards, and provincial traditional Chinese medicine standards - are currently under implementation. Moreover, the national management measures for drug reference materials are about to be revised to enhance the quality and compatibility of reference materials.

What is the current policy environment for the research and development of traditional Chinese medicine?

The Central Committee of the Communist Party of China and The State Council attach great importance to the research and development of traditional Chinese medicine, and have introduced a series of favorable policies to support the research and development of innovative drugs, which have been reflected at all levels and in all regions. The intensity of research and development of traditional Chinese medicine has significantly increased, including the improvement of supporting policies and the strengthening of review and approval. For instance, the recent approval of 1.1-class granules by Hunan Fangsheng demonstrates the enhanced support for the research and development of traditional Chinese medicine.

What are the basic requirements of the drug registration management authority for the development of drugs?

When developing drugs, institutions need to fulfill their obligations and responsibilities to ensure that the research results meet the requirements. Establish a complete pharmaceutical research and development system and pass the on-site inspection as required on December 20, 2021. For non-clinical research, not all project need to be conducted in GLP-certified institutions; only safety evaluations are mandiously required to be carried out in certified institutions.

What is the current status of GLP certification in China?

GLP certification in China still exists. For instance, the GLP institution of the National Institutes for Food and Drug Control has passed the GLP inspection in Japan, but it still exists in the form of certification (now known as extended inspection or compliance inspection), and does not include certifications such as GCP, GSP, GLP, and GMP. Meanwhile, news reports on June 9, 2025, indicated that Qilu Hospital in Jinan, Shandong Province, as a GCP research institution, has its daily management handled by the Shandong Provincial Drug Administration, while the National Drug Administration is responsible for the verification work related to the project.

What are the regulations for the selection of reference preparations in chemical generic drugs?

In the consistency evaluation process of chemical generic drugs, the reference preparations issued by the national Bureau must be adopted. The National Bureau will regularly release a list of reference preparations, including those that have been finalized and are currently soliciting opinions, and this list will be updated over time. In addition, during the drug registration application stage, the applicant and the drug implementation site should meet certain conditions. However, in the future, it may be allowed for domestic applicants to apply for registration with overseas implementation sites.

If serious risks are found in the post-marketing evaluation of a drug, how will the National Medical Products Administration handle it? What are the requirements for the re-registration of drugs?

If the post-marketing evaluation results of a drug show that the drug poses serious risks or has serious toxic and side effects, the National Medical Products Administration will cancel the drug. For instance, the Announcement No. 29 issued on March 17, 2020, cancelled products such as Anaijin. Drug re-registration usually needs to be declared 6 to 12 months in advance. For specific procedures and document requirements, please refer to relevant announcements, such as the announcement on the Re-registration Management of Chemical Raw Materials on October 13, 2023, and the declaration procedures and document requirements for re-registration of domestically produced drugs in October 2024. The re-registration of drugs by overseas enterprises should be directly handled by contacting the CDE.

What changes have been made to the current drug registration process?

Now, an electronic declaration system is in place. The re-registration information needs to be submitted to the national bureau's platform and then forwarded to the provincial bureaus. In addition, the newly established information center has changed the management process of China's drug administration, reducing the provincial protection space and placing greater emphasis on standardization and strictness.

What policies does the state have to encourage the development of children's medication?

The state has implementedLong-term policies encouraging the development of children's medication are in place, and there is a dedicated committee for communication and guidance. Although the latest measures for the protection of drug trial data do not explicitly mention the exclusive rights to children's drugs, the National Drug Administration's official website has a special column on children's drugs, providing relevant guiding principles.

What is the approval policy for rare disease drugs in China?

China has introduced preferential policies for rare disease drugs, including priority review and approval as well as a seven-year market exclusivity period. Meanwhile, through the "Care Program", drugs that meet the requirements for rare diseases can be included in the fast-track approval.

Registration of Traditional Chinese medicineHow about the management situation?

The registration management of traditional Chinese medicine has been gradually improved in recent years. Medicinal materials, decoction pieces and formula granules are not drugs but serve as raw materials for drug production or components for clinical administration. The state has been continuously optimizing the review system for traditional Chinese medicine, with a significant increase in the number of approvals. It also emphasizes the use of the annual report system for medical institution preparations to standardize the human use experience of traditional Chinese medicine and enhance the stability and standardization of preparations.

What are the policies related to the management of Chinese medicinal materials and the import of medicinal materials?

The management of Chinese medicinal materials is determined by their uses. Medicinal materials are managed according to their categories, while those in food and health products are managed according to their corresponding categories. For imported medicinal materials, an approval document management system is implemented. The first import of medicinal materials is approved by the provincial bureau authorized by the State Bureau, and subsequent filing is also carried out by the provincial bureau. The state encourages the import of medicinal materials to supplement domestic resources, among which medicinal materials such as bezoar have been allowed to be imported.

What are the classifications and filing systems for Chinese medicinal materials standards?

Standards for Chinese medicinal materials include national drug standards (including standards for imported medicinal materials) and provincial standards for medicinal materials. Provincial medicinal material standards need to be filed with the national drug standards. Most of the feedback tends to favor filing rather than approval, in order to reduce the strictness of cross-provincial management.

What is the current situation regarding the patent linkage system in drug research and development?

China has established a patent management system for drug research and development, and this system has become more complete after the Sino-US trade negotiations. Patent conflicts not only exist among domestic enterprises but also involve both domestic and foreign ones. The state has established a patent information registration and declaration platform, requiring drug research and development enterprises to conduct patent searches and declarations to ensure compliance with relevant laws and regulations.

What is the current status of the holder System (MAH system)?

The current MAH system may no longer be feasible. Although it was once authorized by the National People's Congress and approved by The State Council, now enterprises have raised doubts about it, believing that the system's criticism of enterprises is too severe.

What are the independence requirements for the drug inspection department?

According to the latest regulatory requirements, the drug inspection department should be independent of the quality department. However, in the current situation of most enterprises, this requirement has not been fully met.

What are the changes in the domestic agent system and the responsibilities of domestic responsible persons?

With the implementation of the new policy, the domestic agent system has been changed to the domestic responsible person system. The domestic responsible person is required to bear legal responsibilities including returns and recalls, compensation and fines, and this role is usually fulfilled by the domestic head office or branch of the overseas enterprise.

What is the development status of the drug traceability system?

Vaccines and medical devices have achieved full traceability, and the traceability system for essential drugs has also begun to be implemented. Traceability work has been gradually implemented in medical institutions to ensure that the sources of drugs can be traced and their destinations can be tracked.

What is the current management status and requirements for pharmacovigilance, contract manufacturing and other links?

At present, the pharmacovigilance process is gradually being adjusted in accordance with the 2021 version of the GVP standards. There are already clear regulatory requirements and supporting documents for aspects such as contract manufacturing, storage, sales, and transportation. However, more guiding principles are still needed in certain areas.

What are the management requirements for post-marketing risk management plans and filing matters of drugs?

Enterprises must file and report in accordance with the post-marketing change management measures for drugs. For major changes that fail to file as required, they may be subject to penalties such as fines.

Regulations regarding the transfer process of drug marketing authorization holders?

It is stipulated that different specifications of the same variety should be transferred to one holder at one time, but in actual operation, there are situations where the implementation standards vary in different regions.

What are the application conditions for drug production licenses and the special requirements for vaccine production licenses?

To apply for a drug production license, one must meet the document requirements issued by the provincial authorities. However, due to its particularity, a vaccine production license not only requires the approval of the provincial government but also becomes more difficult to obtain during the epidemic. New production lines need to be planned in advance and undergo strict inspections.

Which departments' support is needed to establish a new vaccine enterprise? What are the main matters to pay attention to when changing the vaccine production license?

To establish a new vaccine enterprise, it is necessary to obtain support from the Ministry of Industry and Information Technology, the National Health Commission and the provincial government, and also to obtain the vaccine production license issued by the National Administration. When changing the vaccine production license, special attention should be paid to the two types of licensing matters: changing the production address and the production scope.

What are the specific requirements for personnel management in vaccine manufacturing enterprises?

An enterprise should have a full-time production supervisor, quality management supervisor and quality authorized person. Other personnel may hold part-time positions. However, it should be noted that these key managers must be full-time, while other personnel such as managers may be part-time.

Who is responsible for the release of drugs to the market and the review of raw and auxiliary material suppliers?

These key links should be independently completed by MAH, including the supplier review of raw materials and excipients, annual report management, change management, and the release of drugs for market entry, etc. Although procurement, acceptance, sampling inspection and other work can be entrusted, product release cannot be entrusted.

What are the relevant policies regarding overseas production and dynamic batch release?

Overseas production must comply with the regulatory requirements of China. In terms of dynamic batch release, after the implementation of the new policy, there are new regulations for the release of large-scale batches before dynamic batch. Currently, in the pilot stage, Hebei Province allows the sale of batches before dynamic batch under certain conditions.

What are the regulations for vaccine contract manufacturing?

Vaccines can be produced on behalf of others, but the approval authority lies with the national bureau, not the provincial bureau. At the same time, the entrusted production of vaccines must adopt information-based management.

What are the licensing change project when the drug business license is changed?

The licensing project for the change of the drug business license include the change of business mode, business address, business scope, warehouse and quality control person in charge, etc.

What are the main regulatory bases for online drug sales?

The main legal basis for online drug sales includes the Online Sales Supervision and Administration Measures of 2022, as well as the online sales details issued by provincial bureaus, such as those in Yunnan. In addition, third-party platforms need to have the corresponding technical personnel and management systems to review the drugs and ensure that the label information of online sales meets the requirements. In emergency management, once any special circumstances occur, the products should be promptly taken off the shelves and sales suspended. At the same time, the sale of drugs with illegal sources or those that have changed their business methods is prohibited.

What are the special regulations for the management of pharmacists in medical institutions?

In the management of pharmacists in medical institutions, according to Article 107, medical institutions are not allowed to produce certain drugs, such as traditional Chinese medicine injections, medical toxic drugs, chemical preparations and biological products without approved indications, etc. The use of these special drugs must be approved among provincial medical institutions.

How does the mechanism for ensuring the reserve and supply of medicines operate?

The reserve of medicines mainly depends on the reserve arrangements of each province. Generally, 1 to 2 enterprises are selected as the provincial reserves for emergency situations or major epidemics. At the national level, The State Council has the authority to mobilize drug resources across the country for disposal. This system was revised during the COVID-19 pandemic to cope with the impact.

What is the data and competitive landscape regarding generic drugs?

As of June 2025, China Resources Double Crane has 1,842 approval documents, Shanghai Pharmaceuticals Holding 1,312, Kolon 1,242, Shanghai Modern 1,239, Fuxing 1,026, Baiyunshan 934, Stone Pharmaceutical and others 869, and Henan Furen 974. Chengdu Better and other single-product enterprises in Southwest China are strong in strength and can rank among the top ten, keeping pace with large groups.

What are the characteristics of the management of essential medicines, the management of shortage medicines and related systems? Are the penalties for drug violations reasonable?

The management of essential medicines needs to be adjusted regularly, and the general adjustment cycle does not exceed three years. In terms of the management of short-supply drugs, the State Administration for Market Regulation has a list of short-supply drugs, and each province also has its own short-term drug list. The contract manufacturing document of May 2025 stipulates that the contract manufacturing of short-supply drugs is allowed. The state will establish a drug early warning system to strengthen the management of the supply of drugs in short supply. For drug violations, the penalty amount may sometimes be too lenient. For instance, in the case of Sichuan Xieli, although the fine of 0.8% of the sales amount was relatively low, there were still other responsible persons who received corresponding penalties. In addition, supervision and inspection of drug research institutions are becoming increasingly strict, and warnings, rectifications and penalties are imposed on illegal acts such as providing false data.

What are China's policies regarding export restrictions, compulsory patent licensing, and monopoly cases?

Although China has relevant documents restricting exports and compulsory patent licensing, they are rarely used. Although the state has relevant laws for monopoly cases, such as the Anti-Monopoly Law of the People's Republic of China in 2022, it is rather difficult to handle them in practice. The government will monitor the issue of market prices and take corresponding measures.

What are the principles and procedures of exploratory research on drug sampling inspection?

Exploratory research on drug sampling inspection should follow the principles and procedures released in March 2024. If the results of the random inspection and exploratory research are not up to standard, different provinces have different handling methods, which may include fines, production suspension for rectification or issuance of warning letters, etc.

AboutHow is the standardization of administrative inspections related to enterprises and the handling of major safety incidents?

At present, many provinces have issued documents to standardize administrative inspections involving enterprises, aiming to reduce unnecessary disturbances to enterprises and ensure economic development. For major security incidents, each province has emergency response measures and takes measures to investigate and deal with them. In addition, the regulatory charges shall be implemented in accordance with the prices determined by the Price Bureau. In cases of serious violations, the drug registration certificate, medical institution approval document or drug business license may be revoked.

Can active pharmaceutical ingredients be entrusted for production and what are the relevant policy interpretations?

It is a clear policy regulation that active pharmaceutical ingredients cannot be produced on behalf of others. Enterprises must abide by relevant laws and regulations in the production management of active pharmaceutical ingredients and are not allowed to entrust production at will.