China Issues Revised Measures Governing Pharmaceutical Representatives and Academic Promotion Activities

NMPA Announcement No.42 of 2026 – Published May 7, 2026 I Effective August 1, 2026

On May 7, 2026, China’s National Medical Products Administration (NMPA), together with six other central government authorities, published the “Measures for the Administration of Pharmaceutical Representatives” under Announcement No. 42 of 2026. The Measures take effect on August 1, 2026, on which date the “Interim Measures for the Filing Administration of Pharmaceutical Representatives” (2020) are simultaneously abolished.

The Measures establish a broader regulatory framework governing:

• Pharmaceutical representatives
• Academic promotion activities
• Compliance obligations for MAHs, outsourced organizations, healthcare institutions, and representatives
• Interdepartmental enforcement and joint disciplinary mechanisms

For pharmaceutical companies, the revised framework substantially increases compliance expectations, enterprise accountability, and regulatory scrutiny over promotional activities and interactions with healthcare institutions. Foreign MAHs should note that under Article 4, where the MAH is overseas, its designated domestic responsible person is required to fulfill all corresponding management responsibilities under the Measures.

China Expands Oversight of Pharmaceutical Promotion Activities

The revised Measures strengthen oversight of pharmaceutical representative activities and academic promotion practices, with greater emphasis on enterprise accountability, professional qualifications, and compliance controls.

Since implementation of the 2020 interim measures, more than 2,000 marketing authorization holders (MAHs) and approximately 116,000 pharmaceutical representatives have been registered through the national filing platform.

According to the accompanying policy interpretation, regulators concluded that despite improvements in transparency and centralized oversight, some representatives continued engaging in improper sales promotion, commercial bribery, and activities exceeding the scope of legitimate academic exchange — practices that disrupted fair competition and contributed to misconduct within the healthcare sector.

In response, the revised framework moves beyond the earlier filing-focused system and introduces:

• Enhanced qualification standards
• Detailed conduct restrictions
• Broader supervisory responsibilities
• Coordinated enforcement mechanisms involving multiple government agencies

The Measures contain six chapters and 35 articles governing:

• General provisions
• MAH management responsibilities
• Filing administration
• Academic promotion activities
• Supervision and enforcement
• Supplementary provisions

Multiple Agencies Formalize Coordinated Oversight

The Measures were jointly issued and signed on April 28, 2026 by:

• National Medical Products Administration (NMPA)
• Ministry of Public Security
• National Health Commission
• State Administration for Market Regulation
• National Healthcare Security Administration
• National Administration of Traditional Chinese Medicine
• National Disease Control and Prevention Administration

The involvement of seven authorities reflects the government’s broader push toward integrated supervision of pharmaceutical promotion activities, healthcare compliance, anti-corruption enforcement, and market regulation. Each agency carries defined responsibilities under the Measures, eliminating previous supervisory gaps between regulatory systems.

Pharmaceutical Representatives Face Higher Qualification and Conduct Standards

Under the revised rules, pharmaceutical representatives must meet three defined conditions before filing (Article 10):

• Possess at least a junior college degree in medicine, pharmacy, or a related discipline
• Have knowledge of the promoted drug’s pharmacology, toxicology, indications, combination use, adverse reactions, contraindications, and precautions
• Pass training and assessment conducted by the MAH

The third condition — mandatory MAH-conducted training and assessment — is a new and direct compliance obligation on MAHs that affects representative onboarding processes and internal qualification systems.

Filing submissions must include the representative’s name, gender, and photo; identity document type and number; educational background and field of study; labor contract or authorization start and end dates; drug categories and therapeutic areas covered; geographic area of responsibility; a declaration of filing accuracy from the MAH; and a compliance commitment letter signed between the MAH and the representative.

Beyond national platform filing, Article 22 introduces a separate requirement: representatives must also register with each individual healthcare institution before conducting activities there for the first time, through the institution’s designated internal management department. The institution must maintain a registration log and activity record for all representatives.

Under Article 23, healthcare institutions must verify representatives’ identities against the filing platform before granting access; representatives whose identity does not match their filing may not be received. This institution-level registration obligation is distinct from and additional to NMPA platform filing.

Ongoing Filing Maintenance Obligations (Article 17)

Where any filed information changes, MAHs must update the filing within 30 days. Where a representative no longer works for the MAH or authorization is revoked, the MAH must delete the filing within 30 days. For overseas MAHs that change their designated domestic responsible person, the new responsible person must update platform information and re-confirm all existing representative filings within 30 days. These are continuous operational obligations that apply throughout the representative’s engagement.

Academic Promotion Activities Face Stricter Limits

The revised framework defines pharmaceutical representatives as professionals engaged in academic promotion activities on behalf of MAHs rather than sales personnel. Representatives are required to operate strictly within the drug categories, therapeutics, areas, and geographic scope authorized by the MAH.

Representatives may not:

• Conduct activities without filing or registration, or without prior approval from the healthcare institution
• Accept sales targets, collect payments, or process invoices
• Participate in prescription-counting activities
• Provide donations, sponsorships, gifts, consumer cards or vouchers, securities, equity, or other financial products tied to sales volume, or use the names of donations and sponsorships to transfer benefits in disguised form
• Provide kickbacks or any benefits — in any form or under any name — to healthcare personnel, their spouses, children and their spouses, or other specific related parties
• Mislead physicians regarding drug efficacy, conceal adverse reactions, or interfere with rational clinical drug use
• Illegally collect, use, or disseminate patient or institutional information
• Promote products outside the MAH-authorized scope

The extension of the kickback prohibition to named family members (spouses, children and their spouses, and other specific related parties) is a significant widening of scope compared to previous rules and requires revision of compliance policies and training materials.

MAHs and Healthcare Institutions Face Expanded Compliance Obligations

These enhanced restrictions on pharmaceutical representatives are accompanied by expanded compliance and oversight obligations for both MAHs and healthcare institutions.

MAHs Assume End-to-End Responsibility

Dedicated chapters establish end-to-end accountability for the recruitment, authorization, filing, training, assessment, supervision, and conduct management of pharmaceutical representatives, including activities outsourced to third-party professional organizations. Regulators emphasized that MAHs bear primary responsibility for representatives’ conduct regardless of whether activities are conducted directly or through contracted organizations.

Where activities are outsourced, MAHs must evaluate the contracted organization’s capability, establish compliance requirements and breach liability in a written management agreement, and sign individual authorization letters with each representative conducting activities on the MAH’s behalf. Both the management agreement with the organization and the per-representative authorization letters are required.

MAHs are prohibited from:

• Employing or authorizing unqualified representatives or those with records of commercial bribery
• Directing or tolerating unlawful promotional conduct
• Assigning drug sales targets or requiring representatives to collect payments or process invoices

Contracted professional organizations are prohibited from directing or tolerating bribery or fraud, and directing or tolerating improper academic promotion activities.

Under Article 26, where a representative commits a prohibited act, the MAH must promptly correct it. For serious violations, the MAH must terminate the representative’s authorization, delete the filing, publicly disclose the deletion reason on the platform, and pursue liability under the relevant contract. Healthcare institutions may report violations through the filing platform, which refers the matter to the relevant regulatory authority.

Healthcare Institutions Receive Expanded Oversight Duties

Healthcare institutions must establish internal systems governing the reception, supervision, and management of pharmaceutical representatives conducting academic promotion activities within the institution, and notify staff of applicable rules in an appropriate manner and location.

Healthcare institutions and their personnel are prohibited from:

• Interacting with unregistered or unfiled representatives
• Tracking drug usage volumes in violation of applicable regulations
• Accepting kickbacks or improper hospitality 
• Accepting conditional donations, sponsorships, gifts, consumer cards or vouchers, securities, equity, or other financial products tied to drug sales
• Accepting, personally, or through spouses, children and their spouses, or other specific related parties, any kickbacks, donations, gifts, travel, entertainment, or hospitality funded by representatives

Coordinated Enforcement and Joint Disciplinary Measures

A major feature of the revised Measures is the formalization of interagency coordination. The framework establishes information-sharing mechanism, case referrals, coordinated investigations and administrative-to-criminal enforcement cooperation. Authorities that identify violations falling within another agency’s jurisdiction must promptly transfer or report those matters to the appropriate authority.

Joint disciplinary consequences for violations include:

• Public disclosure of administrative penalties imposed on MAHs, contracted organizations, representatives, healthcare institutions, and healthcare personnel
• Increased inspection frequency
• Restrictions on participation in pharmaceutical procurement activities
• Restrictions on signing designated medical insurance service agreements
• Procurement credit-risk warnings and listing in the national enterprise credit information system
• Access-control measures limiting representatives’ ability to enter healthcare institutions
• Penetrating credit evaluation by the National Healthcare Security Administration for MAHs involved in bribery — an assessment that looks through corporate structures to evaluate the MAH’s conduct

Where violations involve party members or public officials, matters must be referred to disciplinary inspection commissions. Where conduct involves criminal bribery or fraud, cases must be transferred to the public security authority in accordance with the Regulations on the Transfer of Cases Suspected of Criminal Offences by Administrative Law Enforcement Agencies.

Industry associations are encouraged to strengthen self-regulation, develop representative industry standards and codes of conduct, and support a governance model combining government supervision, industry self-discipline, and social participation.

Public Access to Filing and Violation Information Will Expand

The NMPA’s pharmaceutical representative filing platform will remain the central information management system. From August 1, 2026, the public may search valid filing information through the platform’s “Public Inquiry” section using a:

• Filing number
• MAH name plus
• Representative names

The platform’s “Violation Disclosure” section will provide access to violation records:

• For filed representatives: searchable by filing number, MAH name plus representative name, or identity document number
• For unfiled representatives: searchable by identity document number only

Transitional Arrangements

Previously completed filings remain valid under the principle of “old rules for existing cases, new rules for new cases.”

After implementation on August 1, 2026:

• MAHs must supplement and complete existing filing information where necessary
• Newly hired or newly authorized representatives must be filed in accordance with the revised qualification and filing requirements
• All representatives must comply with the updated academic promotion conduct rules

Implications for Pharmaceutical Companies Operating in China

The revised Measures carry significant compliance implications for pharmaceutical manufacturers, overseas MAHs, and multinational companies operating in China through local affiliates or contracted promotion organizations. The August 1, 2026 effective date creates a defined compliance window.

Key areas requiring review include:

• Representative qualification and onboarding: All representatives must now satisfy three qualification conditions, including passing MAH-conducted training and assessment. Onboarding processes should be updated accordingly.
• Institution-level registration: Beyond national platform filing, representatives must register at each healthcare institution they visit. Companies should audit current institution access processes against this requirement.
• Filing maintenance: 30-day update and deletion obligations apply to all changes in representative information, contracts, authorizations, and responsible persons. Filing maintenance processes should reflect these ongoing deadlines.
• Outsourced promotion models: Management agreements with contracted organizations must include compliance requirements and breach liability. Individual authorization letters with each representative are separately required.
• Anti-bribery compliance: The extension of kickback prohibitions to named family members (spouses, children and their spouses, and other specific related parties) requires revision of compliance policies, training materials, and healthcare professional engagement guidelines.
• Response procedures: MAHs must have documented procedures for identifying, correcting, and (where necessary) terminating and publicly disclosing representative violations.

As regulatory expectations converge across promotion, documentation, and enforcement, companies increasingly need systems that ensure consistency, traceability, and audit readiness across all representative activities.

For pharmaceutical companies seeking to build compliant, efficient, and well-governed pharmaceutical representative and promotion structures in China, contact Cisema today.

Further Information

• Explore Cisema’s Pharmaceutical Consulting services

References

• Announcement of the National Medical Products Administration, Ministry of Public Security, National Health Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese
• Policy Interpretation of the “Measures for the Administration of Pharmaceutical Representatives”