Proceedings: DIA China 2018

Excerpts from China National Drug Administration Commissioner Jiao Hong’s Keynote Address


ver the past 40 years since the China reform, our country has basically solved the problem of accessibility of medicines, and preventive diagnosis and treatment drugs can basically meet the needs of the public. 

However, we should clearly recognize, according to international standards as benchmarks, that China’s pharmaceutical industry is not strong enough for innovative capacity, the industrial structure is not yet mature, the degree of industrial concentration is not high enough, and the phenomenon of low-level duplication is still prominent. The level of quality and safety protection remains to be further improved.

On the other hand, pharmaceutical innovation is ascending. Corporate R&D investment is continuously strengthening, and innovation capabilities are improving, too, which is an important achievement of our country’s implementation of innovation-driven strategies. It also reflects the continuous strengthening of supervision by the drug administration authorities in recent years and the strengthening of relevant policy effects on innovation. Strong drug supervision and administration have shaped a strong industry.

In June 2017, the former China Food and Drug Administration officially joined the ICH, which means that our national drug supervision will be in line with international standards, international drug technical guidelines, etc. The transformation and implementation of these technical guidelines also means that our regulatory authorities and industry must participate and integrate into international rules, which means that our regulatory capabilities need to be improved. We need to accelerate the pace of modernization of supervision.

We will actively promote the reform of the regulatory system and mechanism and further accelerate the establishment of a modern review system and inspection system. While requiring companies to follow quality management standards and establish a quality management system, we will also improve the quality management of the regulatory authorities. In particular, to strengthen the review and inspection, and to control the internal quality management system, we will actively promote regulatory science and monitor the future development of industry in science and technology.

We will thoroughly grasp advanced international experience, industrial development skills, and China’s national conditions to develop and apply the latest methods, technologies, and tools for supervision in order to accelerate the reduction of relevant institutional costs whilst promoting R&D and innovation.

We will listen carefully to the voices and appeals of enterprises and respond positively to industrial concerns so that we can foster a strong relationship between government and industry. 

We must further accelerate the innovation of supervision methods and build a new regulatory pattern of stringent management and skillful management. To lead industrial innovation that meet the needs of the public, we must address the following related considerations:

First, we must continue to deepen the reform of product review and approval. We must conscientiously implement the requirements of the documents endorsed by the Central Party office and the State Council to ensure that all reform tasks can be implemented according to the time limit.

We must further accelerate the revision of laws, regulations, and rules. The relevant reforms will be solidified in the form of laws and regulations and will further promote the construction of an open and transparent review and approval system that is in line with international standards and in conjunction with the requirements of the State Council’s “distribution service.” Further optimizing and simplifying the relevant review and approval process will improve our review quality and efficiency. By encouraging and accelerating innovation, we can push clinically urgently needed drugs and medical devices to enter the market in the shortest possible time, while promoting the quality and efficacy evaluation of generic drugs.

The second is to pay more attention to the strengthening of daily supervision. We must further apply the principles of risk management and enforce scientific regulatory measures based on in-depth analysis, science-based judgment and accurate identification of potential risks. With a focus on high-risk products, we must strengthen the efforts of flight inspections and overseas inspections. At the same time, we must further reinforce the implementation in enterprises as the main body of quality management and urge enterprises to establish a good governance management system in order to operate effectively. 

We will also further improve the targeting of sampling inspections and focus on relevant products with high risks of concern to the public, focusing on locating problems and conducting inspections. At the same time, we will further strengthen the monitoring of adverse reactions, further highlighting the main responsibility of companies towards reporting of adverse reactions and adverse events.

Third, we will further intensify the crackdown on violations of laws and regulations by maintaining high pressure on relevant violations, by finding problems for relevant companies and responsible persons to investigate and deal with and then in a timely way transfer these crimes to the judicial department. Those who refuse and evade inspection will be punished in accordance with the law. At the same time, in conjunction with the new characteristics of industrial and business development, strengthening the construction of Internet monitoring platforms will strengthen the use of the Internet to monitor falsifications and other related violations of laws and regulations.  For legacy problems, we will also carefully sort out the issues and will try hard to solve them. While enhancing law enforcement, we will also further standardize our working procedures, making law enforcement more transparent and fair.

Fourth, we will further promote smart and transparent supervision. We will further push for electronic administrative licenses and implementing unified management of electronic certificates, providing more convenient services for the public and enterprises. At the same time, we are making every effort to promote the database construction for related products. With the establishment of a variety of archives, we will also strengthen the collection of data on the entire product life cycle, thereby further highlighting accurate supervision. Providing full disclosure of government information and fully implementing the disclosure of regulatory work standards, procedures, and results, we will regularly publish regulatory information related to inspection and punishment, continuously improving the transparency of our supervision work. At the same time, we will intensify cooperation with the press, news and popular science media, allowing the public to participate more and gain support and understanding from them.

Fifth, we will further increase international exchanges and cooperation. The current globalization is an inevitable trend as scientific and technological progress rapidly develops. The development of new drugs has become increasingly complex. The task of ensuring the safety of the drug supply chain should be more arduous. 

No regulatory agencies can operate alone.  Regulatory agencies across the world need to join forces to strengthen cooperation and coordination. We need more extensive, deeper, and systematic promotion of international exchanges and cooperation, while cultivating regulatory personnel that adapt to globalization.

We will strengthen our connection with international standards and promote the sharing and mutual recognition of drug regulatory data with national regulatory authorities to ensure that safe and effective products can enter the Chinese market.