 Home > Active Ingredient News > Drugs Articles > International cooperation | the extraordinary decade of drug administration: contributing China's strength to international drug supervision

International cooperation | the extraordinary decade of drug administration: contributing China's strength to international drug supervision

 Last Update: 2022-10-20
 Source: Internet
 Author: User

Tags

world market pasadena

immunity therapy center reviews

eu harmonized standards

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

(This article was published in the 7th edition on October 10, 2022)

On August 23, the World Health Organization (WHO) announced that China had passed the National Vaccine Regulatory System (NRA) assessment
.
Through the evaluation, it not only means that China has a stable, well-functioning and complete and unified regulatory system, which can ensure that the quality of vaccines produced, imported or circulated in China is controllable, safe and effective, but also an important basis for
China's vaccine exports to the world.

This is a milestone in the construction of China's vaccine national regulatory system in the new era, and it is also a phased achievement
of China's drug supervision in line with international standards.
Since the 18th National Congress of the Communist Party of China, the process of internationalization of drug supervision in China has been deepening, especially after the reform of the drug review and approval system, under the guidance of the goal of leapfrogging from a pharmaceutical country to a pharmaceutical power, the pace of internationalization of drug supervision in China has further accelerated
。 The newly amended "Drug Administration Law of the People's Republic of China" introduces the drug marketing authorization holder system, drug traceability system, pharmacovigilance system, etc.
, the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "New Regulations") require the full implementation of the medical device registrant system, the improvement of the medical device clinical evaluation management system, etc.
, China's national drug regulatory department joined the International Technical Coordination Committee for Registration of Drugs for Human Use (ICH) and was re-elected as a member of the Management Committee.
.
.
From tracking, paying attention, following development to partial leadership, China's drug supervision is moving to the center
of the world stage with an open, cooperative and win-win attitude.

"Internationalization is the two-way integration and coordination
of Chinese and foreign rules.
We take the initiative to learn from the experience of international drug supervision, and also bring China's concept into international rules, contribute 'Chinese wisdom' to global drug supervision, and lay a solid foundation
for promoting China's pharmaceutical industry to 'go global'.
" Qin Xiaoyue, director of the Department of Science and Technology and International Cooperation of the State Food and Drug Administration, said
.

"ICH also needs China Food and Drug Administration"

China's drug review and approval standards and speed are further in line with international standards, and China's drug supervision is gradually moving to the center of the international stage

On June 19, 2017, information released on the ICH website showed that China's national drug regulatory authorities officially joined ICH
.
Today, Wang Xiangyu, Director of the International Organization Division of the Department of Science and Technology and International Cooperation of the State Food and Drug Administration, recalled that he was still very excited when he participated in the voting site: June 1, 2017 was the last day of the first plenary meeting of 2017 held by ICH in Montreal, Canada, and Ms.
Lindstrom, the executive chairman of the conference, announced the voting results and said that ICH welcomed the participation of China's national drug regulatory department.

On June 7, 2018, the NMPA was elected as a member of the ICH Management Committee, becoming a member of the management and decision-making body of ICH, and has more say
in formulating common international technical standards and specifications in the field of drug registration technology.

China's drug regulatory authorities have been on a difficult application path
since 2014.
ICH is the core international rule-making organization
in the field of drug registration.
For a long time, the members of this international organization were only drug administrations and industry associations in developed countries and regions such as the United States, the European Union, and Japan, and no developing country entered
.
Joining ICH means that China's drug regulatory authorities have officially become an important participant in
the formulation of international drug registration standards.

At present, China has become the world's largest API producer and exporter, the second largest pharmaceutical market, the pharmaceutical industry has been integrated into the global industrial chain, has become an indispensable part
of the development of the global pharmaceutical industry.
China's pharmaceutical technical specification guidelines are in line with the internationally accepted technical specification guidelines, which is not only conducive to saving international regulatory resources, but also enables more, better and safer APIs and drugs to accelerate their entry into the international market
.
"Fundamentally, the NMPA needs to join the ICH and ICH needs the NMP, and the two sides have reached cooperation
based on common interests and vision.
" Wang Xiangyu said
.

On June 3, 2021, the NMPA was re-elected as a member of
the I CH Management Committee.
"The re-election shows the international community's recognition of China's drug supervision work and the effectiveness of drug review reform, and is also another milestone in
the process of internationalization of China's drug regulation.
" Qin Xiaoyue said
.

The essence of ICH's work is the internationalization
of review standards.
Since joining ICH in 2017, the national drug regulatory authorities have attached great importance to the transformation and implementation
of ICH guiding principles in China.
As of July 2022, China has fully implemented 57 ICH guiding principles, with an implementation rate of 89%.

At the same time, it deeply participates in the coordination of ICH issues, on the basis of mastering the cutting-edge trends in the field of international drug registration, combined with the actual situation of domestic drug supervision and registration work, constantly improves China's guiding principle system, enhances the scientificity, forward-looking, sensitivity and flexibility of drug supervision work, and contributes Chinese wisdom and strength to global drug supervision work
.
According to statistics, in 2021 alone, China selected 53 experts to continue to participate in the coordination of
38 ICH issue groups.

"From the original system to the current deep participation in the formulation and revision of ICH guiding principles, it is of cross-era significance
.
The transformation and implementation of the ICH guiding principles in China has provided convenience for domestic innovative drugs to quickly enter the international market, which is conducive to promoting the realization of global synchronous research and development and registration
.
Feng Lan, secretary general of the China Pharmaceutical Innovation Promotion Association, said
.

While promoting the integration of evaluation standards with international standards, China's drug regulatory departments are also accelerating their integration into the international "circle of friends"
.
The national drug regulatory authorities actively promote coordination and cooperation with major drug regulatory agencies around the world, establish bilateral cooperative relations with drug regulatory authorities in more than 50 countries and regions, continue to deepen multilateral cooperation with relevant international organizations, establish working relations with 46 international organizations such as the International Union of Drug Regulators (ICMRA) and the Asian Council for Harmonization of Medical Device Regulations (AHWP), and sign 5 cooperation documents with WHO and other international organizations, so that China's drug supervision has gradually moved to the center of the international stage
。

"The whole industry can see that as China opens the door to ICH and deeply participates in the formulation of international registration standards, China's drug review and approval standards and speed are further in line with international standards, and efforts are made to create a good environment for global pharmaceutical innovation and make innovative drugs benefit Chinese patients
more quickly.
" Kang Wei, executive director of the Drug Research and Development Industry Committee (RDPAC) of the China Association of Enterprises with Foreign Investment, said
.

Data show that in 2021, a total of 13 overseas new drugs (including 8 drugs for rare diseases) in urgent clinical need were approved for marketing
.
By the end of 2021, 51 of the 81 varieties of overseas new drugs urgently needed for clinical use had been approved for marketing
.

From participant to leader

China's drug regulatory authorities are contributing more Chinese wisdom to global medical device supervision

In March 2018, the 13th Management Committee Meeting of the International Medical Device Regulatory Forum (IMDRF), hosted by China as the rotating chairmanship, was held
in Shanghai.
At the meeting, the new work project of "clinical evaluation of medical devices" proposed by China was unanimously supported by the participating members and successfully established
.
This marks that after years of efforts, China's medical device supervision has gradually realized the role transformation
from participant to leader on the international stage.

Liu Yinghui, Director of the Clinical Department of the Medical Device Technical Evaluation Center of the State Food and Drug Administration, is the leader of
the clinical evaluation project working group.
According to her, IMDRF was founded in 2011 as a professional international organization
with the participation of medical device regulators.
The "Clinical Evaluation of Medical Devices" project is the first time that China has proposed a new work project to the General Assembly as the project sponsor since joining IMDRF in 2013, and most of the projects carried out by IMDRF before were initiated
by developed countries and regions.

In September 2019, at the 16th IMDRF Management Committee meeting, three project outcome documents led by China's drug regulatory authorities and with the participation of major international regulatory agencies - "Clinical Evidence - Key Definitions and Concepts", "Clinical Evaluation" and "Clinical Trials" were successfully passed and officially released
on the IMDRF official website as international coordination documents in the field of clinical evaluation of medical devices.
The continuation project "post-marketing clinical follow-up study" proposed by China's drug regulatory department was approved at this meeting
.

In September 2020, the 18th IMDRF Management Committee Meeting was held online, and the draft outcome document of "Post-marketing Clinical Follow-up Study" entered the stage of global consultation.
In March 2021, the 19th IMDRF Management Committee Meeting was held online, and the outcome document of "Post-marketing Clinical Follow-up Study" was approved and released
.

"There is such a set of data: from March 2018 to March 2021, IMDRF has eight working groups active, and China-led working groups publish one-third of the outcome documents issued by all working groups
.
" Liu Yinghui said
proudly.

The international coordination document on clinical evaluation of medical devices led by China systematically clarifies the relevant issues in the field of clinical evaluation of medical devices, which is not only an effective reflection of the new concepts, new ideas and new methods of clinical evaluation of medical devices in the world, but also a concentrated embodiment
of the reform of China's drug review and approval system.
It is worth pointing out that the clinical evaluation normative documents supporting the new Regulations are equivalent to transforming the above international coordination documents, further improving the clinical evaluation management system of medical devices, reflecting scientific evaluation ideas, and optimizing clinical evaluation requirements
.

The electronic declaration information system (eRPS) for medical device registration is another important measure
for China's medical device supervision to be in line with international standards.
In June 2019, eRPS was officially put into operation
.
The electronic declaration directory structure implanted in the system fully adopts the IMDRF Medical Device Registration Specification Catalogue (RPS ToC), which can realize the electronic declaration and online review of various medical device registration applications in accordance with RPS format, which is conducive to the applicant's international application for listing
.

"China is the first country
in the world to adopt the RPS ToC catalog in the electronic declaration system for medical devices.
" Zhang Shiqing, deputy director of the Quality Management Department of the Instrument Review Center of the State Food and Drug Administration, said that the system has also played an important role in emergency review during the new crown pneumonia epidemic, and the online submission of information has facilitated the personnel of enterprises who cannot go out due to the impact of the epidemic, and ensured the smooth transmission and submission of enterprise declaration materials and the remote operation
of reviewers.

In addition, in March 2018, at the 13th IMDRF Management Committee meeting, the new work project of "Updating the List of International Standards Recognized by IMDRF Members" proposed by the China Institute of Food and Drug Control (Medical Device Standards Administration Center of the State Food and Drug Administration) on behalf of China was approved; In July 2020, the medical device standard project "Medical Electrical Equipment Part 2-90 Basic Safety and Basic Performance of High-flow Respiratory Treatment Equipment" proposed by China was approved.
.
.

Be a contributor to global development

China's drug regulatory authorities actively carry out international cooperation and contribute to building a community of human health

On May 18, 2020, at the opening ceremony of the videoconference of the 73rd World Health Assembly, President Xi Jinping delivered a speech, calling on all countries to unite and cooperate to defeat the epidemic and jointly build a community of human health, and announced that after the development of China's new crown vaccine is completed and put into use, it will be used as a global public good to make China's contribution
to the accessibility and affordability of vaccines in developing countries.

The NMPA has thoroughly implemented it, actively carried out international cooperation, and contributed to building a community of human health
.
Carry out work related to international cooperation on vaccines, and promote the coordination of vaccine review and approval in China with the WHO Emergency Authorization (EUL); Organize WHO experts and Chinese drug review experts to hold special meetings on vaccine EUL to study, and coordinate and arrange WHO experts to inspect manufacturers of new crown vaccines in China on site; Provide and disclose the regulatory requirements and quality standards
of China's epidemic protection articles and diagnostic reagents.

On May 7, 2021, the WHO announced that the new crown vaccine developed by Sinopharm Beijing Company will be included in the "emergency use list"; On June 1 of the same year, the WHO announced that the new crown vaccine developed by China Sinovac Zhongwei Company was included in the "emergency use list"; On May 19, 2022, the WHO announced that the adenovirus vector new crown vaccine of China CanSino Biologics Co.
, Ltd.
was included in the "emergency use list".
.
.
It shows the trust and support
of the international community for China's pharmaceutical industry and drug supervision.

"Chinese vaccines have played an important role
in boosting immunity and saving lives globally.
" Bruce Aylward, senior adviser to the WHO Director-General, said at a WHO press conference on January 6 that through the "new crown pneumonia vaccine implementation plan" led by the organization and partners, more than 180 million doses of Sinopharm and Sinovac new crown vaccines
have been delivered to 49 countries and regions.

One by one "Chinese vaccines" to the world, writing a vivid story of building a community of human health and health, but also reflecting China's responsibility as
a major country in international drug supervision.

On August 23, 2022, the WHO announced that China had passed the NRA assessment
.
NRA evaluation is an important institutional arrangement for WHO to evaluate vaccines in various countries, and since 2006, WHO has used NRA evaluation as a precondition
for purchasing vaccine products in the country.
In 2011 and 2014, China passed the NRA assessment
twice.

On July 4, 2014, Dr.
Margaret Chan, then WHO Director-General, announced that China's national vaccine regulatory system had passed the WHO re-evaluation
.
Photo by Deng Qiao

In fact, China's drug regulatory authorities have always maintained good communication with WHO, and have carried out all-round exchanges and cooperation
in the fields of drug accessibility, adverse drug reaction monitoring, combating counterfeit and inferior drugs, vaccines and drug prequalification.
In October 2019, the NMPA and WHO signed a letter of intent to further cooperate
in improving the regulatory system and improving regulatory capabilities.
At present, China has three WHO cooperation centers (WHO Biological Products Standardization and Evaluation Cooperation Center, Drug Quality Assurance Center, Traditional Medicine Cooperation Center); By the end of 2021, a total of 6 vaccines, 41 chemical drugs, 55 active APIs, and 2 drug testing laboratories in China had passed WHO precertification
.

Overseas inspection is an important measure for
China to exercise its power to supervise imported drugs.
In December 2011, China dispatched inspection teams abroad for the first time to carry out on-site inspections
of overseas drug production.
In December 2018, the Administrative Provisions on Overseas Inspection of Drugs and Medical Devices was officially promulgated, setting the same global regulatory standards
for domestic and foreign drugs.
Overseas inspection has become a powerful means to
protect the safety of Chinese people's drug use and exercise China's foreign drug supervision power.

It is worth mentioning that in September 2021, the State Food and Drug Administration launched the pre-entry application for
the Drug Inspection Cooperation Program (PIC/S).
PIC/S is an authoritative organization
in the field of international drug inspection composed of drug inspection agencies from different countries and regions.
The application to join PIC/S is an important step taken by China's drug regulatory authorities in the internationalization of supervision, and it is also a positive manifestation of
accelerating the internationalization process of drugs in China.

"The NMPA benchmarks against international rules, continues to promote regulatory innovation, and is committed to promoting China's leap
from a pharmaceutical power to a pharmaceutical power.
" We also hope to further achieve global regulatory synergy and trust
through effective international cooperation.
Qin Xiaoyue said
.

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.