NMPA (National Medical Products Administration)

Who regulates medicines in China?

In one sentence

The NMPA is China's medicines regulator: a national bureau under the market regulation administration that approves drugs, devices and cosmetics.

Its ten responsibilities run from drafting the laws to post-market risk management, and date from the 2018 State Council reform that folded the former food and drug administration into a new market regulator. Adverse drug reaction (ADR) reports go to its Center for Drug Reevaluation, the National Center for ADR Monitoring: 2.6 million of them in 2024.

Where it sits

GovernmentThe State Council
RegulatorState Administration for Market Regulation (SAMR)
BureauNMPA, Beijing, with provincial drug administrations it guides
ReportsCenter for Drug Reevaluation, the National Center for ADR MonitoringWith provincial, municipal and county monitoring institutions

Think of it like this

Think of a country where every hospital ward keeps a notebook of side effects and sends a copy up the line. The office in the capital reads the sum: 2.6 million pages a year, nine in ten written by hospitals.

Key insights

A bureau inside the market regulatorHospitals write the reports15 days, at once, 30 daysAt the table since 2017

The 2018 cabinet reform made one market regulator out of three agencies with overlapping duties over food, drugs and products, and the NMPA sits under it as a national bureau. Its list of responsibilities has ten items, from drafting the laws and keeping the Pharmacopoeia to organising adverse reaction monitoring and guiding every provincial drug administration.

In 2024 the national monitoring network took 2.597 million adverse reaction reports, 1,842 per million inhabitants, from 98.7 percent of China’s counties. Medical institutions wrote 91.2 percent of them, holders 3.7 percent. Chapter 2 sets the clocks.

The reporting rulebook of 2011 gives three clocks: new and serious reactions within 15 days, a death at once, everything else within 30 days; for a new drug every reaction counts. The 2019 law wrote “pharmacovigilance system” into statute, and the 2021 Good Pharmacovigilance Practice tells holders how to run one.

China’s regulator joined the International Council for Harmonisation (ICH) in 2017 and was elected to its Management Committee in 2018, two years after it began rebuilding its review system. The NMPA is also a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). It is not in the inspectors’ scheme PIC/S.

Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself

Chapter 1

Which three moments made the NMPA what it is?

Pick a year. Each added a layer to how China watches its medicines.

2011A rulebook with three clocks2019The law names pharmacovigilance2021Good practice for holders

A rulebook with three clocks

On 1 July 2011 the Ministry of Health’s Provisions for Adverse Drug Reaction Reporting and Monitoring came into force: a state reporting system, monitoring institutions in every municipality and county, one national network for every report.

Article 21 set the clocks still in use: new and serious reactions within 15 days, a death at once, other reactions within 30 days. Article 20 widened the net: every reaction for a new drug during its observation period, and for an imported medicine for five years. A manufacturer must investigate each death and report within 15 days.

What it left behind: a reporting duty on hospitals as much as on companies, which is why hospitals still write most of the reports.

The law names pharmacovigilance

China’s Drug Administration Law dates from 1984. The revision adopted on 26 August 2019, in force from 1 December, was the first to say that “the State establishes the pharmacovigilance system”. Article 80 makes marketing authorisation holders monitor, collect, track and analyse suspected reactions and act on risks; article 81 makes holders, manufacturers, distributors and medical institutions report suspected cases promptly to the drug regulator and the health authority.

The law landed in a regulator already turning outward. Review reform had begun in 2015, China’s regulator joined the ICH in 2017 and won a seat on its Management Committee in 2018, the year the NMPA itself was formed under the new market regulator.

What it left behind: a statutory word, pharmacovigilance, and a holder who answers for it.

Good practice for holders

On 7 May 2021 the NMPA issued the Good Pharmacovigilance Practice under the Drug Administration Law and the Vaccine Administration Law, to standardise how marketing authorisation holders and trial applicants run pharmacovigilance. It came into force on 1 December 2021, and every holder had 60 days from the announcement to register in the National ADR Monitoring System.

The practice gave the NMPA something to inspect. In 2024 the national centre ran holder inspections and its safety evaluations fed 33 NMPA announcements revising package inserts, while the network’s intake grew to 2.6 million reports.

What it left behind: a holder system the regulator can audit, inside a reporting system the hospitals still carry.

Chapter 2

Your report, their clock

A case has reached your company. The 2011 Provisions set the deadline with two questions: is it serious, and is it already on the package insert? Pick a cell.

On the insertNot on the insertSeriousSerious, knownSerious, newNot seriousNot serious, knownNot serious, new

Or it is something else: a death or a medicine in its first years

A serious reaction, known or not, and any reaction not on the package insert, goes through the national monitoring network within 15 days of discovering or learning of it. The same clock binds manufacturers, distributors and medical institutions. Provisions for ADR Reporting and Monitoring, Articles 15 and 21

A known, non-serious reaction has 30 days, but only while the drug is in its reporting window: the observation period for a new domestic drug, five years for an import. For older products only new and serious reactions are reported. Provisions for ADR Reporting and Monitoring, Articles 20 and 21

A death is reported immediately. The manufacturer then investigates the case and files an investigation report with the provincial monitoring institution within 15 days. Provisions for ADR Reporting and Monitoring, Articles 21 and 22

For a domestic drug in its observation period, and for an imported drug in its first five years, every adverse reaction is reported, serious or not, known or not. Provisions for ADR Reporting and Monitoring, Article 20

Drug manufacturers, distributors and medical institutions shall report any new and serious ADRs no later than 15 days from discovering or becoming aware of the information, death case shall be reported immediately, and other ADRs shall be reported no later than 30 days.
Provisions for Adverse Drug Reaction Reporting and Monitoring, Article 21, in the NMPA’s English translation

Individuals may report to their doctor, the company or the local monitoring institution. The counts show who does: of the 2.597 million reports in 2024, 91.2 percent came from medical institutions, 5.0 percent from distributors and 3.7 percent from holders. Serious reports were 17.5 percent.

Chapter 3

Side by side with Europe

China runs its own rulebook. Five places where it differs from the European Union (EU).

	The EU rule	The Chinese rule
Who decides	The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines	The NMPA, a bureau under the market regulator, which guides every provincial drug administration
Where a serious case goes	EudraVigilance within 15 days, wherever it happened	The national ADR monitoring network within 15 days; a death at once
A non-serious case	90 days if it happened in the Union	15 days if new to the insert; 30 days if known, and only while the drug is in its reporting window
Who reports	The holder to EudraVigilance; Member States encourage professionals and patients	Medical institutions and distributors under the same duty as holders; hospitals wrote 91.2 percent of the 2024 reports
Who reads the report	The national competent authority and the EMA	Municipal and county monitoring institutions first, then the provinces and the national centre

Show the legal references

Who decides: Regulation (EC) No 726/2004, Article 10(1); NMPA, Main Responsibilities, items 3 and 9.
Serious cases: Directive 2001/83/EC, Article 107(3); Provisions for ADR Reporting and Monitoring, Articles 15 and 21.
Non-serious cases: Directive 2001/83/EC, Article 107(3); Provisions, Articles 20 and 21.
Who reports: Directive 2001/83/EC, Articles 102(a) and 107; Drug Administration Law, Article 81; the 2024 annual report.
Who reads: Directive 2001/83/EC, Article 102; Provisions, Article 12; the NMPA page on the Center for Drug Reevaluation.

Same 15 days, a wider net: in China the hospital is a reporter by law, and a new drug’s every reaction is a case.

The facts, in one place

What it is	A national bureau under the State Administration for Market Regulation, formed in the 2018 State Council reform; ten responsibilities, from drafting the laws to post-market risk management.
Since	2018, under a Drug Administration Law first adopted in 1984 and revised in 2019.
Who decides	The NMPA and its departments; affiliated centres do the technical work, among them the Center for Drug Evaluation and the Center for Drug Reevaluation.
Seat	Beijing, Zhanlan Road, Xicheng district.
Reports	To the National Center for ADR Monitoring, through institutions in every province, municipality and county.
2024 in numbers	2.597 million adverse reaction reports, 17.5 percent serious; 1,842 per million inhabitants; 98.7 percent of counties reporting; 33 package insert revision announcements.
Member of	The International Council for Harmonisation (ICH) as a regulatory member since 2017, on its Management Committee since 2018; the International Coalition of Medicines Regulatory Authorities (ICMRA).

Don’t confuse it with: the Center for Drug Evaluation

Center for Drug Reevaluation

The monitoring centre

Does: organises adverse reaction monitoring and post-market safety evaluation, and guides the local centres
Is: the National Center for ADR Monitoring, a public institution of the NMPA
Example: evaluates a drug’s reports and recommends an insert change

Center for Drug Evaluation

The review centre

Does: the technical review of clinical trial and marketing applications
Is: another affiliated institution of the NMPA, with a near-identical name
Example: reviews a new drug’s dossier so the NMPA can approve it

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“In China a non-serious reaction never needs a single-case report.”

MythTruth

MythYou got it.Not quite.

A reaction not on the package insert counts as new and has 15 days whatever its severity, and for a new domestic drug or an import in its first five years every reaction is reported, within 30 days if known and not serious.

“A death case must be reported immediately.”