INSTITUTION PROFILE
NMPA
— China’s medicines regulator, whose review reforms increased the flow of domestically originated new drugs
NMPA is the regulatory authority of the Chinese government and does not make medicines themselves. RolesManagement of the amount of medicine sold in China (approved) and establish the system and technical guidelines for examinationComment After reforming the examination and approval system that began in 2015 and joining ICH in 2015, New Drugs Approved in China (New Drugs) became 76 items in 2025. 、PAHow much does drug discovery and DDS affect?Squeeze and organize.
- In 30 seconds, the PA.
- What kind of organization is the type of influence?
- What is DDS?
- Scope of influence (authorization and region)
- Companies and organizations involved
- Future Prospects
- Glossary/Source/Ins ment and Source Response Table
In 30 seconds, the PA.
(National Chemical Supervision Bureau)National Medical
The influence of NMPATwo Directionswork. One is an influence as an approval authority for overseas companies who want to sell drugs in China. OtherGrow new drug candidates created by Chinese companies to internationally used dataThe impact of the foundation. NMPA Becomes ICH Regulatory Member in 2017 FactsHome In 2025, we established a route to examine clinical trial applications for international joint clinical trials in 30 business days. FactsHome There is a change in this system in the background of the increase of contracts introduced by leading overseas pharmaceutical companies.
2. What kind of organization is the type of influence?
The drug discovery and DDS articles will not make medicines yourself, unlike companies. instead ofWhat pathways will affect the industry?is divided into four types.
3. What is DDS?
| Activities | Home | Numbers/Examples |
|---|---|---|
| Manage registration (approved) | The registration management system must be strictly audited and approved by City. Actual technical examination is conducted by the Pharmaceutical Review Center (CDE). | Apply for pharmaceutical market in 20254,087 foundedapproved, and new drug76 items(previous) 230 new drugs for 5 years from 2021 to 2025 |
| Acceleration System | In the 2020 chemical note management valve methodConditional Approval, Priority Review, Special Review4 procedures | The application deadline for City is 200 days, for priority screening it is 130 days, and for rare diseases approved overseas it is 70 days, and for those approved domestically it is 60 days. |
| 30 days of clinical trial | 2025 Public Notice on Drugs, Diagnostics and Rare Diseases, Clinical Trials and Approvals in City.World Concurrent Development(including 3-phase international joint trials led and co-led by domestic investigator) | Applicants are accepted30 daysReview and approval |
| International harmony | Participate in international supervision rules and standard formulation (PAPA’s responsibilities) | In 2017, the predecessor CFDA joined ICH’s regulatory bodies. Selected as a member of ICH Management Committee in 2018 |
In August 2015, the opinions of the National Academy of State (National[2015]44]) were the issues at the time.Retention of application waiting for examinationHome Clinically rushed to say that it takes too long to approve new drugs, By the end of 2016, we have set our goal to achieve the end of 2018 approval. FactsHome The accelerated system and 30-day route are on the extension line of this reform.
4. Scope of influence (authorization and region)
| What NMPA has | Not having | |
|---|---|---|
| PharmaceuticalsClinical trials in China proceed under the approval of PA and other rights in China are licensed to overseas companies.Operation of registration management system, standard of pharmacy, and technical guidance principles | Authorities to publicly publicize the rules of the judging system (Representation of the National Market Supervision Bureau) | |
| Region | China MarketHome The medicine of overseas companies is only available in China. Instructing the chemical supervision department of Ministry, Autonomous Region and Direct Control City | Authorization to determine the availability of sales in other countries |
| International Location | ICH regulators (membered in 2017) | ICH’s Position as a Founding Member |
| Overseas expansion of new drugs from China | Boost global simultaneous development, including international joint clinical trials for 30 days routes | Permission to review and approve the license agreement itself (contract is linked to the company) |
216 people set forth in 2018Public Administration (Capacity)It is not the number of employees of the agency such as CDE, which is responsible for the examination FactsHome The number of employees and budget of PAPA including CDE are not listed in the primary information confirmed in this article. Undetermined / FutureHome In addition, "76 new drugs" is a number of classifications in the Chinese system, and it is not comparable simply because the definition of "novel drug" of the FDA is not the same.
5. Companies and organizations involved
There is a contract to introduce new drug candidates for Chinese companies as "rights other than China" by major overseas pharmaceutical companies. The article published on NMPA website is as a general manager of the National Pharmaceutical Supervisory Committee in January 2026. Amount of licensing transaction for new drug overseas$13 billionIt is said that it is beyond FactsHome However, the period and method of ag。ation are not shown.
| Contents (Announcement of each company) | Relationship with this series | |
|---|---|---|
| Pfizer × 3SBio(May 2025) | PD-1 and VEGF-targeted double-specific antibody SSGJ- PD license worldwide except China. $12.5 billion, milestone up to $48 billion. Multiple clinical trials are ongoing in China at the time of presentation | Pfizer |
| GSK × Heng Medicine (July 28, 2025) | PDE3/4 In、tor HRS-9821 for COPD and up to 11 drug options. $5 billion per hour, milestones could be around $1.2 billion. | About GSK |
6. Future Prospects
| Read | Primary Information | |
|---|---|---|
| Candidates from China can start international joint clinical trials earlyIn foreign companies from early stagesMake it easier | The 30-day route includes the 1st and 2nd phase trials of simultaneous global development and the 3rd phase international joint trials led by domestic clinical trials | |
| In 2026, NMPA launched new drugs for new and new targets.Approved for the world first in ChinaStrengthen support for (China) | Explanation of 2026's priority work by NMPA's site article | Undetermined / Future |
| A data protection system for pharmaceuticals and market-exclusive periods for rare diseases and market exclusivity. | In the same article, the data protection system will be transferred to the implementation, and the system for the exclusive period will be set up. | Undetermined / Future |
7. Glossary
- CDE
- NMPA Pharmaceutical Review Center Conducts a technical examination of clinical trials and applications for drugs.
- New Drugs
- A new drug that is divided into "New Drugs" in the Chinese system. NMPA announces annual approvals.
- Exceedings
- A procedure that defines drugs that are expected to be more obvious than existing treatment with heavy illness and prioritizes consultation and examination during development.
- License
- Give the right to develop and sell your drug candidates. View from the receiving side.
- 3
- The provision of the Chinese government agency's ability, internal organization, and personnel capacity.
8. Source
- China Government Network (Central Mechanism Control Commission Valve Office) Copyright (C) 2018 National Pharmaceuticals Bureau. All Rights Reserved. https://www.gov.cn/zhengce/2018-09/10/content_5320814.htm
- Office National Institute of Pharmaceutical Products and Medical Instruments, Inc. Resolve the residual residue, approve as expected in 2018, and speed up reviewing new drugs). https://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm
- National Market Supervisory Bureau (China Government Network and State Office) Copyright (C) 2019 National Market Supervision Bureau. All Rights Reserved. Article 13 Acceleration System, Article 59, 63, 68, and Article 96 Examination Deadline. https://www.gov.cn/gongbao/content/2020/content_5512563.htm
- NMPA NMPA Announcement on Clinicalizing of the Review and Approval Process for Clinical Trials https://english.nmpa.gov.cn/2025-10/14/c_1138494.htm
- NMPA National Bureau: "Chinese New Drugs" (January 7, 2026) 4,087 applications approved for over 2025, 76 new drugs, 230 items from 2021 to 2025, license transactions overseas, and 2026 priority work. https://www.nmpa.gov.cn/yaowen/ypjgyw/zhyw/20260108085003119.html
- ICH ICH Association 2017 Annual Report (CFDA, China and HSA, Singapore) https://admin.ich.org/sites/default/files/inline-files/2017AnnualReport_ICH_Association.pdf
- ICH ICH Association 2018 Annual Report https://admin.ich.org/sites/default/files/inline-files/2018_ICH-AnnualReport_2019_0506.pdf
- ICH Members & Observers (Members PA, China) https://www.ich.org/page/members-observers
- Pfizer Press Release "Pfizer Enters into Licensing Agreement with 3SBio" (May 2025) SSGJ- Clinical trial is a clinical trial in China, with a total of $12.5 billion worldwide, except in China. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-enters-exclusive-licensing-agreement-3sbio
- GSK GSK and Hengrui Pharma enter agreements to develop up to 12 innovative medicines worth $5 billion, HRS-9821, milestone in mainland China, Hong Kong, Macao, Taiwan, approximate $120 billion. https://www.gsk.com/en-gb/media/press-releases/gsk-and-hengrui-pharma-enter-agreements/
9. Response table of claims and sources
| Content | ||
|---|---|---|
| 216 administrative braiding, mentoring departments of the Ministry of Education, Culture, Sports, Science and Technology, etc. | Facts | Source 1 https://www.gov.cn/zhengce/2018-09/10/content_5320814.htm |
| Opinion of reform in 2015: elimination of congestion, approval of expiration date, and faster review of new drugs | Facts | Source 2 https://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm |
| 4 accelerated system, examination deadlines (200 days for City application, 130 days for priority, 70 days for overseas approved rare disease, 60 days for clinical trial), public text as National Market Supervision Bureau Decree. | Facts | Source 3 https://www.gov.cn/gongbao/content/2020/content_5512563.htm |
| 30 working days of clinical trials | Facts | Source 4 https://english.nmpa.gov.cn/2025-10/14/c_1138494.htm |
| 2025 Approval 4,087 New Drugs 76 Items, 230 Items for Five Years, Over $1,300 Billion in License Transactions, and Over 2026 | Facts | Source 5 https://www.nmpa.gov.cn/yaowen/ypjgyw/zhyw/20260108085003119.html |
| CFDA, China | Facts | Source 6 https://admin.ich.org/sites/default/files/inline-files/2017AnnualReport_ICH_Association.pdf |
| Selected as ICH Management Committee in 2018 | Facts | Source 7 https://admin.ich.org/sites/default/files/inline-files/2018_ICH-AnnualReport_2019_0506.pdf |
| ICH’s Founding Member is the U.S. and the PA’s Regulatory Member. | Facts | Source 8 https://www.ich.org/page/members-observers |
| Pfizer and 3SBio | Facts | Source 9 https://www.pfizer.com/news/press-release/press-release-detail/pfizer-enters-exclusive-licensing-agreement-3sbio |
| GSK and Heng Pharmaceuticals Agreement | Facts | Source10 https://www.gsk.com/en-gb/media/press-releases/gsk-and-hengrui-pharma-enter-agreements/ |
| Engine Four Mold Segment | The analysis of this paper. | This article |
| Total number of employees and budgets of the entire PAPA including CDE, and the total duration and method of the licensing transaction amount | Undetermined / Future | Not listed in Source 1 and 5. This article does not estimate |
| Chapter 6 Prospects ()ulation 1 item / Undetermined 2 item) | Interpre of this document from the description of source 4 and 5 |
Last Updated:September 26, 2026/Troy Technical
The figures of this paper are based on the provisions, laws and regulations published on the Chinese government network, PAPA's public notices and site publications, ICH's annual report, and announcements by companies. This is an interpretation that reads from primary information. This article does not recommend certain medicines.