By the PharmaTradz BD Team. Published October 2026.
NMPA stands for the National Medical Products Administration, the national regulator for medicines, medical devices and cosmetics in the People's Republic of China. It approves drugs for the Chinese market, sets quality standards, oversees manufacturing and monitors safety after approval. Many people outside China still call it the "China FDA", a habit left over from its former name, the China Food and Drug Administration (CFDA).
For a foreign company, NMPA decides whether a medicine can be sold in China, who must hold the licence and how each shipment is cleared.
From SFDA to CFDA to NMPA
China's drug regulator has been reorganised several times. The State Food and Drug Administration (SFDA) was restructured in March 2013 as the China Food and Drug Administration (CFDA), a ministry-level body. In the 2018 reform of government institutions, food safety moved elsewhere and the drug side became the National Medical Products Administration, placed under the newly created State Administration for Market Regulation (SAMR). That is why some registration rules are issued as SAMR orders.
In 2017, while still CFDA, the regulator joined the International Council for Harmonisation (ICH), the body that writes the shared technical guidelines used by the US, EU and Japanese regulators. It has sat on the ICH Management Committee since 2018 and has adopted ICH guidelines on quality, safety, efficacy and dossier format.
Who does what
| Body | Role for a foreign company |
|---|---|
| NMPA | Grants marketing approval and sets policy |
| Center for Drug Evaluation (CDE) | Technical review of clinical trial and marketing applications; runs the online platform for API, excipient and packaging registration |
| Center for Food and Drug Inspection (CFDI) | Registration and GMP inspections, including inspections of overseas sites |
| National Institutes for Food and Drug Control (NIFDC) | Laboratory testing and verification of quality standards |
| Provincial medical products administrations and port drug regulators | Local licensing and inspection; import filing and clearance at designated ports |
The laws that matter
The foundation is the Drug Administration Law of the People's Republic of China, comprehensively revised on 26 August 2019 and in force since 1 December 2019. It made the marketing authorisation holder system national, abolished separate GMP certificates and set out the routes for faster approval.
The detailed procedure sits in the Provisions for Drug Registration (SAMR Order No. 27), promulgated in January 2020 and in force since 1 July 2020. They define the registration categories, the four expedited pathways and the review time limits.
The most recent change is the revised Regulations for the Implementation of the Drug Administration Law (State Council Decree No. 828), signed on 16 January 2026 and in force since 15 May 2026. They widen regulatory data protection, introduce market exclusivity for qualifying paediatric and rare-disease medicines, and set out the duties of the domestic entity that represents an overseas holder. NMPA is still issuing supporting rules, so check the latest notices.
The marketing authorisation holder and the local agent
Under the 2019 law, the marketing authorisation holder (MAH) is the company or research institution that holds the drug approval. The MAH is responsible for the product across its whole life: development, manufacture (its own or contracted), distribution, safety monitoring and recalls.
A foreign company can be the MAH, but it cannot act alone. Article 38 of the law requires an overseas MAH to designate an enterprise legal person inside China to perform the MAH's obligations, and that entity shares joint liability with the MAH. The 2020 Provisions apply the same rule to overseas applicants during registration. The 2026 Regulations add that this domestic entity must have real quality-management and risk-control capability, proper staff, and its details printed on the package leaflet. It is usually a Chinese subsidiary or a specialist agent.
How an imported drug is registered
Imported drugs follow the same categories as domestic ones: innovative, modified new and generic chemical drugs; innovative, modified and already-marketed biological products; and traditional Chinese medicines. The dossier is filed with CDE in Chinese, in the ICH Common Technical Document (CTD) structure. A CTD prepared for Europe or the US can largely be reused; our guide to CTD vs ACTD explains the format.
Overseas clinical data can be used. NMPA's Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data (July 2018) allow full, partial or no acceptance, depending on whether the data are complete, meet ICH good clinical practice and show no ethnic factors that would change safety or efficacy in Chinese patients. Since a CFDA decision in October 2017, innovative chemical drugs and therapeutic biologics no longer need approval in their home country before applying in China, and China can join global trials from phase I.
Once approved, the product receives a drug approval number. For drugs made overseas the format is 国药准字 H (Z, S) J plus a four-digit year and a four-digit serial number, where H means chemical drug, Z traditional Chinese medicine, S biological product and J an overseas-made product.
The four expedited pathways
| Pathway | Who it is for |
|---|---|
| Breakthrough therapy | Innovative or modified new drugs for serious diseases with no effective treatment, or clearly better than existing treatment |
| Conditional approval | Drugs for serious unmet needs or urgent public-health needs, where trial data predict benefit; confirmatory studies follow approval |
| Priority review and approval | Urgently needed drugs in shortage, innovative drugs for major infectious or rare diseases, new paediatric products, needed vaccines, and drugs already in the first two pathways |
| Special approval | Medicines needed in a public-health emergency |
The review time limits in the Provisions are 200 working days for a standard marketing application, 130 under priority review and 70 for urgently needed rare-disease drugs already marketed overseas. Time spent answering questions is not counted, so real timelines are longer. Clinical trial applications are deemed approved if CDE raises no objection within 60 working days, and since September 2025 a 30-working-day review applies to certain innovative drugs.
APIs: the associated review system
China does not license most APIs (active pharmaceutical ingredients) on their own. Under the associated review and approval system, APIs, excipients and primary packaging are reviewed together with the finished product that uses them. Industry calls this China's DMF system; our explainer on what a DMF is covers the wider idea.
The API maker files its data on the CDE platform and receives a registration number. Overseas makers file through a representative office or an entrusted Chinese agent. The finished-product applicant quotes that number with a letter of authorisation. The public record shows the status "A" once the API has passed technical review linked to an approved product, and "I" while it has not. An API for generic or imported drugs already on the Chinese market can also be reviewed separately. If you are weighing API sources for China, see our China and India sourcing comparison.
Getting goods through the port
An approval number alone does not clear a shipment. Under the Drug Administration Law, drugs must enter through ports where drug importation is permitted. The importer files a record with the port drug regulator, which issues an import clearance document (the Import Drug Clearance Form, or "Drug Import Note" in NMPA's English translation of the law), and customs releases the goods on that basis. The port drug testing institute samples the goods for testing. Drugs sold in China for the first time, and biological products named by NMPA, must pass this testing before they can be sold. The detailed steps sit in the Measures for the Administration of Drug Import, last revised in 2012.
Early access before full registration
Several routes let patients receive a medicine before full approval:
Hainan Boao Lecheng International Medical Tourism Pilot Zone. Hospitals there may use urgently needed medicines and devices that are marketed abroad but not in China, with provincial approval. Real-world data from there can support an NMPA application.
Greater Bay Area. Under a measure in force since 2021, designated hospitals in the nine mainland cities of the Greater Bay Area may use drugs and devices registered and used in Hong Kong or Macao public hospitals, for urgent clinical need, with Guangdong provincial approval.
Urgent hospital imports. Article 65 of the law lets a medical institution import limited quantities of a drug for urgent clinical need, with approval. Our guide to named-patient import programmes compares such routes worldwide.
Separately, NMPA Announcement No. 96 of 2025 lets certain drugs marketed overseas import batches made before Chinese approval, so launch stock is ready.
GMP and overseas inspections
Manufacturing must follow China's Good Manufacturing Practice for Drugs (2010 Revision), in force since March 2011 and designed to be consistent with WHO GMP. Separate GMP certificates were abolished on 1 December 2019; compliance is now checked through inspections, including pre-approval inspections. Under NMPA's 2018 overseas inspection rules, inspectors can visit foreign sites and their API, excipient and packaging suppliers to check that manufacture matches the registration. A refusal to cooperate is recorded as a failure, and serious deficiencies can lead to suspension of imports. NMPA applied to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2023 and was accepted as an applicant that November, which starts a formal assessment of its inspection system.
A worked example
Suppose an overseas company holds an injectable rare-disease medicine approved in Europe but not in China. It appoints its Chinese subsidiary as the domestic responsible entity. Its API supplier files on the CDE platform and issues a letter of authorisation. The company files its CTD in Chinese, with an ethnic-factor analysis of its overseas trials, and requests priority review. Because the drug is urgently needed and already marketed overseas, the review time limit is 70 working days rather than 200. Meanwhile, a Boao Lecheng hospital treats a few patients under the pilot. After approval, it receives a number beginning 国药准字HJ. Its first commercial shipment enters through a permitted port and is tested before sale, because it is a first import.
What a foreign exporter should prepare
Before you approach NMPA or a Chinese partner, answer these questions:
Who will be your domestic legal entity, and does it have the quality staff and systems the 2026 Regulations expect?
Is your dossier ready in CTD format and in Chinese, with all overseas clinical data and an ethnic-sensitivity analysis?
Has your API maker filed on the CDE platform, and will it issue a letter of authorisation? Will your excipient and packaging suppliers do the same?
Do your specifications meet the Chinese Pharmacopoeia (the 2025 edition has applied since 1 October 2025)?
Is your site ready for an NMPA inspection, with records that match the registered process exactly?
Which port will you use, and how will you hold stock while first-import testing is completed?
For NMPA's contact details, see our directory of drug regulatory authorities of the world.
How PharmaTradz can help
Our dossier licensing and registration service connects you with partners who prepare CTD dossiers and support filings in China and other markets. If you need an API maker with a CDE registration, or a finished product for export, tell us the product, market and documents you need and send us an RFQ. For other terms, see our pharma abbreviations A-Z.
Frequently Asked Questions(FAQs)
What is the full form of NMPA?
NMPA stands for the National Medical Products Administration, China's national regulator for medicines, medical devices and cosmetics. It sits under the State Administration for Market Regulation (SAMR).
Is NMPA the same as the China FDA?
Yes, in everyday use. "China FDA" is an informal name left over from the China Food and Drug Administration (CFDA), which became NMPA in the 2018 government reform.
Can a foreign company hold a drug registration in China?
Yes. An overseas company can be the marketing authorisation holder, but it must designate an enterprise legal person in China to carry out its obligations, and that entity shares joint liability for the product.
Does NMPA accept foreign clinical trial data?
Yes. Under NMPA's 2018 principles, complete overseas data that meet ICH good clinical practice can be fully or partly accepted, depending on whether ethnic factors could change safety or efficacy in Chinese patients.
How long does NMPA take to approve a new drug?
The Provisions for Drug Registration set a review time limit of 200 working days for a standard marketing application, 130 under priority review and 70 for urgently needed rare-disease drugs already marketed overseas. Time spent answering questions is not counted, so the real timeline is longer.
