1. Compliance Guidelines for the Healthcare Industry
On January 14, 2025, the State Administration for Market Regulation (SAMR, 国家市场监督管理总局) published the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Compliance Guidelines, 医药企业防范商业贿赂风险合规指引). The Compliance Guidelines compile the mainstream interpretation of China's anti-corruption regulatory framework, similar to the Foreign Corrupt Practices Act Resource Guide published by the U.S. Department of Justice and the U.S. Securities and Exchange Commission.
2. Enforcement Focus for 2025
On May 13, 2025, 14 Chinese government agencies jointly
published the Notice on Promulgation of the Key Points for
Rectifying Misconduct in the Field of Pharmaceutical Purchase and
Sales and Medical Services in 2025 (The 2025 Notice,
关于印发2025年纠正医药购销领域和医疗服务中不正之风工作要点的通知),
highlighting the focus areas for regulatory enforcement in the
healthcare industry for the coming year.
The 2025 Notice emphasizes building upon and consolidating prior
years' developments in healthcare compliance. It notes that in
2025, regulators will continue to focus on the sale and
distribution of medical products (i.e., medical devices and
pharmaceuticals) and misconduct relating to medical services.
Regulators will also target key personnel with authority in
critical areas such as public procurement and bidding,
prescriptions, and project review and funding. Enforcement will
also be tightened in high-risk areas such as genetic testing,
protection of patient information, online medical services, and
China's state-run medical insurance. Regulators will also
strengthen government audits of the healthcare sector and refine
the "social credit" evaluation system for healthcare
companies. The 2025 Notice also encourages healthcare companies to
utilize the Compliance Guidelines.
Unlike the 2024 Notice, the 2025 Notice does not mention service
fees or speaker fees paid to public healthcare professionals
(HCPs), but generally notes that HCPs should comply with
anti-corruption requirements. This change may be a positive sign
that the strict restrictions imposed in recent years on public
HCPs' ability to work with life sciences companies may be
loosening.
3. Updates to the Social Credit Evaluation System for Public Procurement
On May 20, 2025, the National Healthcare Security Administration (NHSA, 国家医疗保障局) published the Notice on Further Refining the Drug Pricing and Procurement Credit Evaluation System (2025 Credit Evaluation Notice, 国家医疗保障局办公室关于进一步完善医药价格和招采信用评价制度的通知).
The current credit evaluation system was established in 2020 and
refined in 2023. Companies with "dishonest practices"
(失信行为), namely misconduct such as
bribery and antitrust violations, will receive negative credit
evaluations and face punishment, up to and including debarment from
public procurement, a particularly serious measure in a country
such as China, where the healthcare system is largely state-run.
According to the NHSA, from September 2021 to April 2025, a total
of 734 companies received negative credit evaluation results
ranging from "Average" to "Extremely
Serious."
The 2025 Credit Evaluation Notice makes revisions to the credit
evaluation criteria and process that will be implemented in Q3
2025. These revisions are reflected in three documents published
with the 2025 Credit Evaluation Notice and summarized below:
| Document | Highlights |
|
Catalog of Dishonest Practices 医药价格和招采失信事项目录清单 |
|
| Discretionary Criteria of Dishonest Practices 医药价格和招采信用评价的裁量基准 |
|
| Operation Standards of Credit Evaluation 医药价格和招采信用评价的操作规范 |
|
4. Final Whistleblower Regulations Published
On May 29, 2025, three government agencies jointly published the Notice on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (Whistleblower Notice, 关于对药品医疗器械质量安全内部举报人举报实施奖励的公告), the final version of a draft published for comment in October 2024.
This program aims to reward whistleblowers who report
significant quality and safety issues relating to drugs and medical
devices. The final Whistleblower Notice has a narrower scope than
the earlier draft. Under the final Whistleblower Notice, the reward
program will only apply to individuals who file complaints under
their real names and who are (1) company employees, or (2)
"related informants," a term that includes former
employees who terminated their employment contracts within one year
of reporting misconduct, vendors who work with companies on safety
and quality issues, and temporary contractors engaged by companies.
Media personnel and individuals or entities that were significantly
engaged in the reported misconduct are not eligible to receive
whistleblower awards.
The Whistleblower Notice also refines the process of investigating
the alleged misconduct and providing rewards. The Notice allows
rewards to be provided when allegations are verified and before
penalties are imposed, expediting the provision of rewards and
further incentivizing potential whistleblowers. It also introduces
"joint credit disciplinary measures" targeting
whistleblowers who falsify materials or commit fraud to avoid abuse
of the reward program. The Whistleblower Notice also adds a
requirement that any government investigation resulting from the
whistleblower's report should be "necessary" and
targeted, to balance between the need to investigate the reported
misconduct and the legitimate business operations of the companies
that are the subject of the reports.
5. Additional Compliance Guidance
On April 18, 2025, the Shanghai Administration of Market Regulation published the Casebook on the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Casebook,《医药企业防范商业贿赂风险合规指引》配套典型案例).
The Casebook aligns with the Compliance Guidelines and provides case studies illustrating the nine categories of high-risk activities listed in the Guidelines. Like the Guidelines, the content of the Casebook is well within the mainstream understanding of compliance requirements, as can be seen from these case studies:
| High-Risk Activity Category | Summary | Aggravating/ Mitigating Factor(s) |
| Academic Visits and Communications |
A pharmaceutical company's sales representative paid cash kickbacks to a department director and head nurse during monthly academic visits in return for individual HCPs' prescription data. Funds for the kickbacks were embezzled from the sales representative's reimbursement of sales expenses. |
Aggravating factor: The pharmaceutical company did not cooperate with the investigation. |
|
The person in charge of a medical device distributor provided kickbacks to a department director during academic visits in return for the increased use of consumables. |
N/A | |
| Speaker Fee/Service Fees for HCPs |
A medical device distributor falsified meeting invitations, sign-in sheets, contracts, and other supporting documents to provide "speaker fees" and "consulting fees" to HCPs who never provided any speaker or consulting services. |
Mitigating factor: The medical device distributor actively cooperated with the investigation. |
| Clinical Research |
A pharmaceutical manufacturer provided shares in an affiliated company to the director of a clinical research facility and also instructed a clinical research organization to make cash payments to the director to facilitate the initiation of clinical trials. |
N/A |
6. Recent Enforcement Actions
The government's anti-corruption campaign in the healthcare sector continued in 2025. In the past six months, several healthcare companies, including multinational companies, have been subject to administrative fines for providing improper benefits to HCPs, such as holiday gifts or improper service fees. For example, on May 27, 2025, the Changning District Administration of Market Regulation in Shanghai issued an enforcement decision, imposing a fine of approximately 70,000 USD (RMB 500,000) on a European pharmaceutical company for falsifying academic events and providing speaker fees to public HCPs relating to these falsified events in order to increase sales. Notably, the enforcement decision specified that the investigation arose out of a whistleblower report.
There have also been significant enforcement actions targeting government officials in the healthcare sector. In February and May, two former officials of the National Medical Products Administration (NMPA, 国家药品监督管理局) were investigated by the Central Commission for Discipline Inspection of the Communist Party of China (CCDI, 中共中央纪律检查委员会 中华人民共和国国家监察委员会) for "serious violations of discipline and law," although as is customary, no further details of the investigations were disclosed. The two former officials are:
- Shifei Chen (陈时飞), former Deputy Director of the NMPA from September 2018 to August 2022. During his tenure, Chen was primarily responsible for nationwide drug registration, evaluation, and approval, including overseeing the Center for Drug Evaluation (国家药品监督管理局药品审评中心). Chen also participated in the administration of the centralized procurement of drugs through volume-based purchasing while serving at the NMPA.
- Jingquan Bi (毕井泉), former Director of the NMPA from January 2015 to March 2018. During his tenure, Bi primarily initiated new schemes for drug approval, including an expedited approval process for generic drugs. He also introduced new regulatory programs, including the Marketing Authorization Holder system.
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