Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent legislation to improve China’s drug regulatory capacity and why it potentially marks a new era for the country’s innovative pharma industry.


On April 27, 2021, the General Office of China’s State Council issued the ‘Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building’ (hereafter the ‘Implementation Opinions’) which systematically lay out a blueprint for building up China’s drug regulatory capacity and which mark a new stage in the country’s drug regulation reform.

The ‘Implementation Opinions’ put forward 18 key tasks and five safeguard measures on the direction for building up drug regulatory capacity in China and propose several specific implementation paths. After careful study, I have identified a few key learnings in terms of drug standard management capabilities, technical review capabilities, traditional Chinese medicine review capabilities, digital regulatory capabilities, and regulatory internationalization levels.


Improve standard management capabilities and actively implement the “four most stringent” requirements

The internationalization of national drug standards is essential for improving the quality of drugs, promoting the research and development of innovative drugs, promoting international mutual recognition, synchronizing global clinical trials for innovative drugs, and accelerating the globalization of Chinese drugs.

The “Implementation Measures” propose specific methods for improving management capabilities. The first is to improve the new working mechanism led by the government, the main enterprise bodies, and with the participation of society more broadly.

In order to scientifically and efficiently improve the management efficiency of national drug standards, the “Implementation Measures” clarify the responsibilities and division of labour of all parties, formulate relevant encouragement and incentive supporting measures for relevant departments in the next step, and establish a working mechanism for the formulation and revision of drug standards in which all parties actively participate.

Secondly, there needs to be active participation in the coordination of relevant international standards in order to improve the degree of consistency with international standards. As early as 2017, the former State Food and Drug Administration joined the International Coordinating Committee on Technical Requirements for the Registration of Human Drugs (ICH) and was successfully elected as a member of the Management Committee in 2018. Over the past few years, China has fully implemented the ICH guidelines and promoted the scientific development of China’s drug registration standards.


Improve technical review capabilities and promote the innovation and development of China’s pharmaceutical industry

Technical review capabilities play a central role in the entire pharmaceutical innovation chain. The “Implementation Opinions” summarized China’s successful experience in accelerating vaccine and drug review during the COVID-19 prevention and control period, proposed the establishment of a joint work mechanism for emergency and innovative drug and medical device research and review, and created new drug researchers and reviewers to jointly promote standards. The revised new working mechanism reflects the essential laws of medical innovation, and helps to promote the R&D and review of emergency and innovative drugs and medical devices more scientifically and efficiently. This is bound to profoundly influence and reform the development model of China’s pharmaceutical industry.

If China wants to become a world medical power, it must have the ability to approve “global new” innovative drugs. The “Implementation Opinions” clearly states that “disclosure of expert opinions, review results and review reports in accordance with the law” have an important impetus on improving China’s drug and medical device review capabilities and standards. Fairness in the review process is an important part of the construction of an environment conducive to pharmaceutical innovation, and an open and transparent working mechanism is the system guarantee for obtaining fair and just results; this active review and approval mechanism is important for improving China’s drug review capabilities and standards.


Actively apply China’s digital technology development achievements to drug supervision, and continuously improve digital drug management capabilities

The vigorous development of digital technology has led to the emergence of a digital drug supervision model. The use of digital means to strengthen drug supervision has become a general trend. The informatization, digitization and networking of drug supervision are effective means to ensure drug safety, improve supervision efficiency, and realize the combination of management and service. The “Implementation Opinions” proposed “improving the information traceability system”, “promoting the full life cycle digital management”, and “improving the application service level of ‘Internet + drug supervision'”, which indicates that the digital transformation of China’s drug supervision will open an acceleration channel.

The establishment of a full-cycle traceability system for drugs is an important starting point for drug safety supervision, and it has organically combined the existing scientific and technological development with drug supervision whereby “The source can be found and whereabouts can be traced”. It is necessary to give full play to the capabilities of modern digital technology and Internet technology to strengthen drug risk control, adverse reaction reports, and drug whole-process management, to achieve objective data and to further enhance the response ability and response of drug supervision.


Improve the international level of supervision and join hands to build a community of human health

The “Implementation Opinions” propose China’s deep participation in the international regulatory coordination mechanism and active participation in the formulation of international rules. The strengthening of international exchanges and cooperation with key countries and regions in drug regulation will also be crucial, as will the use of key products and key areas as breakthroughs to promote mutual regulatory recognition. China’s leadership will be important to ensuring that the region’s drug regulatory capacity can reach an internationally advanced level. A specific implementation path has been put forward for improving the internationalization of China’s drug supervision.

Improving the international level of drug supervision is an important manifestation of China’s soft power. In the future, China should further participate in the formulation of international rules which have not seen major changes in a century, especially in the post-pandemic era. China’s stronger international participation can provide developing countries with more high-quality and affordable pharmaceutical products and demonstrate China’s position as a major power.

We must realize multilateral and bilateral regulatory mutual recognition, accelerate the “going out” and internationalization of China’s innovative pharmaceutical products; further release domestic pharmaceutical production capacity and make pharmaceutical product exports a new growth point for China’s foreign trade. In the process of the internationalization of medicines, we will continue to improve our country’s drug regulatory quality and management system to illuminate ourselves and others.