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Speakers:

Ms. Jiao Hong, commissioner of the National Medical Products Administration (NMPA)

Mr. Xu Jinghe, deputy commissioner of the NMPA

Mr. Zhao Junning, deputy commissioner of the NMPA

Mr. Huang Guo, deputy commissioner of the NMPA

Chairperson:

Ms. Xing Huina, deputy director general of the Press Bureau of the State Council Information Office (SCIO) and spokesperson of the SCIO

Date:

July 5, 2023

Xing Huina:

Ladies and gentlemen, good morning. Welcome to this press conference held by the State Council Information Office (SCIO). This is the 18th briefing in the series "Embarking on the New Journey — A Government Perspective." Today, we have invited Ms. Jiao Hong, commissioner of the National Medical Products Administration (NMPA), to brief you on strengthening drug regulation to ensure drug safety for the public and to take your questions. Also joining us today are Mr. Xu Jinghe, deputy commissioner of the NMPA; Mr. Zhao Junning, deputy commissioner of the NMPA; and Mr. Huang Guo, deputy commissioner of the NMPA.

Now, I'll give the floor to Ms. Jiao Hong for a brief introduction.

Jiao Hong:

Ladies and gentlemen, friends from the media, good morning. I'm very glad to have such an opportunity to meet you here. First of all, on behalf of the NMPA, I would like to express my gratitude to friends from all sectors and the media for your support in advancing drug supervision. Today, my colleagues and I will speak with you about strengthening drug regulation to ensure drug safety for the public.

As we all know, drug safety is of paramount importance, as it directly impacts people's health, life and well-being, as well as the economic development and social harmony of our nation. Since the inception of the NMPA, we have firmly implemented General Secretary Xi Jinping's vital instructions on drug supervision. We have fully aligned ourselves with the major decisions and plans of the CPC Central Committee and the State Council. With a people-centered development approach, we have fully implemented the "four most stringent" requirements (most rigorous standards, strictest supervision, most severe punishment, most serious accountability), and prioritized safety while driving progress. We have continuously deepened the reform of the drug and medical device review and approval system, and strengthened quality supervision throughout the life cycle of drugs. This ensures overall stability in drug safety, propelling our country's transition from a big pharmaceutical nation to a strong pharmaceutical powerhouse, safeguarding and promoting public health.

First, we are committed to strictly preventing risks and effectively maintaining the overall stability of drug safety. We revised the Drug Administration Law and formulated the Vaccination Administration Law, and implemented a robust drug information traceability system. Additionally, groundbreaking reforms have been achieved in the management of vaccines. In 2022, our national vaccine regulatory system passed the third assessment of the World Health Organization (WHO), reflecting the active contribution of Chinese vaccine products to global public health. Special efforts were made to rectify drug safety issues, imposing severe penalties for violations of laws and regulations. Furthermore, we intensified supervision on key products, including those selected in the national centralized procurement process, and continuously improved quality control throughout their life cycle. Thanks to strengthened supervision, the overall pass rate of national drug sampling inspection has risen impressively from 97.1% to 99.4% over the years.

Second, we adhere to innovation-driven approaches to serve and support the high-quality development of the pharmaceutical industry. The review and approval system for drugs and medical devices has been orderly promoted, with an optimized review and approval process, leading to numerous innovative drugs and medical devices being approved for market. Over the past few years, we have approved a total of 130 innovative drugs and 217 innovative medical devices. In the first half of this year, 24 innovative drugs and 28 innovative medical devices were approved for market, effectively meeting the healthcare needs of the people. We implemented the decisions and deployments of the CPC Central Committee and the State Council, issuing the Opinions on Facilitating the Inheritance, Innovation and Development of Traditional Chinese Medicine. Additionally, we promoted the establishment of a review technical standard system tailored to the characteristics of traditional Chinese medicine, resulting in the approval of 31 new traditional Chinese medicines and supporting the inheritance and innovative development of traditional Chinese medicine. We have also made significant progress in the quality and efficacy consistency evaluation of generic drugs, with 615 varieties passing the evaluation, further meeting the people's demands for medicine.

Third, we insist on building a solid foundation and comprehensively strengthening drug supervision capacity. We put into action the Implementing Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Supervision to promote scientific, legal, international and modern drug supervision. We completed the formulation and revision of key regulations, including the Drug Administration Law, Vaccination Administration Law, Provisions for Supervision and Administration of Medical Device Distribution, and Provisions for Supervision and Administration of Cosmetics. Additionally, we issued 13 regulations and promulgated and implemented the 2020 Chinese Pharmacopoeia. As a result, the drug supervision system and standard system have been substantially established. To support nationwide regional development strategies, we established four drug and medical device review and inspection sub-centers in the Yangtze River Delta and the Greater Bay Area. Moreover, we implemented the Opinions on Establishing a Team of Professionalized and Specialized Drug Inspectors. The provincial drug inspection teams now have more than 20,000 members, further strengthening the foundation of drug supervision. We comprehensively enhanced international exchanges and cooperation, and the NMPA continuously gained more say and influence internationally.

Ladies and gentlemen, over the past five years, remarkable development and progress has been made in drug supervision, largely due to the strong leadership of the CPC Central Committee with Comrade Xi Jinping at its core and the scientific guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era. This year marks the first year of fully implementing the guiding principles of the 20th CPC National Congress. The NMPA will adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era and take the opportunity of in-depth themed education to fully implement the guiding principles of the 20th CPC National Congress. We will earnestly implement the "four most stringent" requirements and follow the working philosophy of "being politically aware, strengthening supervision, ensuring safety, promoting development and benefiting people's livelihood" to effectively ensure drug safety for the people and strive to establish a modern drug supervision system with Chinese characteristics.

Next, my colleagues and I will address your questions. Thank you.

Xing Huina:

Thank you for your introduction, Ms. Jiao. The floor is now open to questions. Please identify the media outlet you represent before raising your questions.