China Finalizes Regulations for Pharmaceutical Sales Representatives

On May 7, 2026, China’s National Medical Products Administration (NMPA), in conjunction with six other government agencies,¹ issued the Management Measures for Medical Representatives (Management Measures, 医药代表管理办法), which will take effect on August 1, 2026.

The Management Measures represent a long anticipated and significant development in China’s regulatory framework for the pharmaceutical industry. The Management Measures are the final version of the Draft Management Measures for Medical Representatives, which were published for public comment in November 2024 (2024 Draft, 医药代表管理办法(征求意见稿)),² and replace the December 2020 Management Measures for Record-Filing of Medical Representatives (Trial Version) (2020 Trial Measures, 医药代表备案管理办法(试行)).

In this Advisory, we summarize key changes and their implications for industry. Pharmaceutical companies operating in China should assess their compliance posture, particularly their policies for and monitoring of their sales force. While the Management Measures do not apply to the medical device and medtech sector, the NMPA has announced that similar regulations for the medical device and medtech sector are forthcoming, so companies in the sector should view the Management Measures as a preview of coming regulations.

Background

The Management Measures generally maintain the overall structure of the 2024 Draft, with some important adjustments and a few clarifications, and represent a significant change over the 2020 Trial Measures, which are still currently in effect.

While the 2020 Trial Measures primarily focus on the record-filing process for medical representatives and their promotional activities, the Management Measures are more comprehensive, covering not only the conduct of medical representatives, but also that of Marketing Authorization Holders (MAHs), healthcare institutions, and healthcare providers. This is consistent with Chinese regulators’ continued emphasis on end-to-end compliance management.

MAHs: Increased Supervisory Liabilities

One significant change from the 2024 Draft is restoring requirements found in the 2020 Trial Measures relating to third-party professional services organizations engaged by MAHs to promote the sale of drugs, such as contract sales organizations (CSOs). This change shows that regulators recognize the practice of using CSOs,³ which was previously a grey area. When engaging CSOs, MAHs are required to assess the CSOs’ capabilities, include compliance requirements and liabilities for breach of contract in their service contracts, and execute contracts for the management of medical representatives. (Article 8.2) The Management Measures also formally impose compliance requirements on professional services organizations, which largely parallel the obligations imposed on MAHs, e.g., not to retain medical representatives with a record of commercial bribery. (Article 12)

Another notable revision in the Management Measures is a prohibition on MAHs and professional services organizations “condoning” (纵容) medical representatives’ illegal activities. (Article 11) The 2024 Draft prohibited MAHs from directing illegal activities. This expansion from regulation of MAHs’ affirmative misconduct to include tolerance of employees’ misconduct may be intended to restrict MAH’s ability to evade corporate liability.

Other new obligations placed on MAHs in the 2024 Draft are generally preserved in the Management Measures. For instance, MAHs are prohibited from employing or authorizing medical representatives who are unqualified or have records of commercial bribery (Article 11), and are required to ensure that their medical representatives sign compliance commitment letters. (Article 15)

Medical Representatives: Requirements and Prohibitions

The Management Measures generally maintain the restrictions on medical representatives’ conduct introduced in the 2024 Draft. For example, medical representatives are prohibited from providing kickbacks or other improper benefits to healthcare professionals (HCPs) and/or persons with close relationships to HCPs, such as family members or close friends. In addition, the Management Measures adjust the requirements for what information should be submitted on the Record-Filing Platform (the Platform), and lowered the requirements for medical representatives’ academic qualifications and professional experience.

The Management Measures contain stronger protections for patient privacy. While the 2024 Draft prohibited medical representatives’ unauthorized disclosure of patient information, the Management Measures further prohibit medical representatives’ illegally collecting, using, and/or disseminating patient information. This is an important expansion, and aligns with recent enforcement actions targeting medical representatives for improperly obtaining patients’ personal information.

The Management Measures provide that medical representatives are required to register at healthcare institutions when first conducting promotional activities, a change from the 2020 Trial Measures, which only required medical representatives to obtain healthcare institutions’ consent to promotional activities. Given this change from a consent-based framework for promotional activities to a registration-based framework, companies may wish to review their internal approval processes for promotional activities taking place at healthcare institutions, including HCP visits and departmental meetings.

Enhanced Enforcement Measures

The Management Measures maintains the 2024 Draft provisions explicitly setting forth mechanisms for cooperation among various government authorities in monitoring and investigating misconduct by MAHs, medical representatives, HCPs, and healthcare institutions. In addition to delineating the scope of responsibilities for each government authority, such as the social credit evaluations conducted by healthcare security administrations,⁴ the Management Measures require collaboration and information sharing among authorities, which further aligns with recent enforcement trends.⁵

The Management Measures retain the 2024 Draft’s emphasis on commercial bribery as a primary target for regulatory enforcement, and add “fraud” as another area of focus.⁶ This addition of “fraud” likely refers to fraud against China’s state-run medical insurance program, which has been the subject of increasingly intense enforcement actions by Chinese regulators.⁷ If regulators find evidence of commercial bribery, fraud, or other illegal activity, they may not only publish their findings of misconduct on the Platform, but also require the MAH to publicly disclose the misconduct on the MAH’s own website. MAHs may also face additional penalties, including public disclosure of findings of noncompliant conduct, targeting for enhanced regulatory scrutiny, and debarment from public procurement programs.

Takeaways

Chinese regulators remain focused on anti-corruption in the life sciences industry. The Management Measures provide a number of new regulatory requirements which pharmaceutical companies may wish to consider when reviewing their compliance programs:

• Promotional Activities. Review internal controls around the approval and monitoring of promotional activities, particularly for activities taking place at healthcare institutions.
• Hiring and Employment. Ensure that hiring processes for medical representatives comply with the Management Measures, including background checks for evidence of commercial bribery and having medical representatives sign compliance commitment letters.
• Third Parties: Implement appropriate due diligence, contracting, and monitoring processes for third-party promotional services organizations.
• Training and Documentation: Conduct regular compliance training for medical representatives and maintain appropriate books and records systems.

For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold & Porter’s Life Sciences or White Collar Defense & Investigations practice group.

* Zhewen Zhang contributed to this Advisory.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.