A new regulatory framework for medical representatives will take effect in China on August 1, 2026. The National Medical Products Administration (NMPA), together with the Ministry of Public Security, National Health Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and National Bureau of Disease Control and Prevention, announced the 'Medical Representative Management Rules' (hereafter 'Rules') on April 28, 2026. The previous 'Medical Representative Filing Management Rules (Trial)' will be abolished simultaneously.
Under the new Rules, information already filed on the medical representative filing platform remains valid, but newly filed representatives must meet the updated qualification requirements. Separate regulations for similar promotional personnel of medical device companies are to be developed later.
The Rules consist of 35 articles in six chapters, covering definitions, employment criteria, filing procedures, conduct standards, and the responsibilities of all parties. Marketing authorization holders are designated as primarily responsible for managing their representatives through the entire process. They are prohibited from hiring individuals with a history of commercial bribery or assigning sales tasks to representatives.
Medical representatives themselves must hold a college degree or higher in medicine, pharmacy, or related fields, possess knowledge of their promoted drugs, and pass training by the holder. Their academic activities are limited to conveying drug information, assisting rational use, and gathering feedback; they may not engage in sales, compile prescription statistics, or offer any kickbacks or benefits.
Healthcare institutions must establish internal management systems, register medical representatives, and verify their identities via the platform. Institutions and their staff are forbidden from accepting donations, kickbacks, or other benefits tied to sales conditions.
For filing management, the NMPA is responsible for building a unified national filing platform. Holders must submit corporate information, personal details of representatives, employment terms, and the product categories and regions covered. Each representative receives a unique filing number. Any changes or departures must be updated within 30 days.
A joint supervision mechanism is a key feature. Drug, health, public security, market regulation, and medical insurance authorities will share information and transfer leads. Joint penalties include publicizing violations, restricting procurement and medical insurance eligibility, and listing on dishonest entities. Criminal cases are referred to police, and disciplinary violations to supervisory organs.
The Rules encourage public oversight and industry self-discipline, and require public disclosure of administrative penalties.
(Note: All facts in this report are based solely on the official announcement, without added information.)