On the evening of May 7th, the National Medical Products Administration, together with seven departments including the Ministry of Public Security, the National Health Commission, the State Administration for Market Regulation, the National Healthcare Security Administration, the State Administration of Traditional Chinese Medicine, and the State Administration for Disease Control and Prevention, issued the "Management Measures for Pharmaceutical Representatives". This method will come into effect on August 1, 2026.

In September 2020, the National Medical Products Administration issued the "Administrative Measures for the Filing of Pharmaceutical Representatives (Trial)", establishing a system for the filing of pharmaceutical representatives, which came into effect in December of that year. However, in reality, there are still a few pharmaceutical representatives who exceed their academic promotion and technical consulting responsibilities, engage in drug sales, and even participate in commercial bribery, disrupt market order, affect the healthy development of the pharmaceutical industry, and promote unhealthy practices and bad habits in the pharmaceutical industry.

The revised "Management Measures for Pharmaceutical Representatives" focus on clarifying the holder's access to pharmaceutical representatives, the registration and behavior norms of pharmaceutical representatives, the management of pharmaceutical academic promotion and reception by medical and health institutions for pharmaceutical representatives, and the management responsibilities of relevant units.

On May 8th, Fu Xiaoyu, a partner at Shanghai Bangxinyang Law Firm, explained to Jiemian News that the supervision of pharmaceutical representatives has entered the era of full process closed-loop compliance supervision from the trial stage of single filing management. From a single department to the drug regulatory joint public security, health commission, municipal supervision, medical insurance, traditional Chinese medicine, and disease control departments, a linkage mechanism has been established for information sharing, clue transfer, joint punishment, and execution connection, eliminating regulatory blind spots and achieving full coverage of pharmaceutical supervision.

Bribery of 30000 yuan will result in imprisonment

Prior to this, in the actual commercial activities of pharmaceutical promotion, the identity of pharmaceutical representatives often fell between academic promotion and sales.

Entering medical institutions under the guise of "academic promotion" and communicating drug information with medical and health personnel such as doctors and pharmacists; At the same time, they bear sales pressure within the company, and even undergo assessments around prescription volume, drug usage, and payment results. It is precisely in this gray space that the industry has previously developed issues such as prescription statistics, sales linkage, cost reimbursement, conference sponsorship alienation, and disguised benefit transfer through donations and subsidies.

The "Management Measures for Pharmaceutical Representatives" first provide a clear definition of the identity of pharmaceutical representatives. The Measures for the Administration of Pharmaceutical Representatives stipulate that pharmaceutical representatives refer to practitioners employed or authorized by drug marketing authorization holders to transmit, communicate, and provide feedback on drug information to medical and health institutions (including traditional Chinese medicine medical institutions and disease prevention and control institutions) and their staff, and engage in drug academic promotion activities.

Fu Xiaoyu told Jiemian News that the essential difference between pharmaceutical representatives and traditional drug sales is that they are strictly prohibited from assuming any drug sales functions. The new regulations further clarify that the core positioning of pharmaceutical representatives is professional academic promotion, responsible for professional information communication, transmission and collection, feedback on clinical medication, adverse reactions, and clinical needs.

What behaviors can and cannot be done should also be clearly defined and regulated. The "Regulations on the Administration of Medical Representatives" also explicitly prohibit behaviors.

Fu Xiaoyu stated that the core orientation of the list of nine prohibited behaviors in the new regulations can be summarized as follows: no promotion without filing and approval, no binding of sales indicators, no participation in unified prescriptions, no disguised benefit transmission, no interference with clinical rational drug use, no illegal acquisition of information, and no unauthorized promotion. This is also consistent with the enforcement views of regulatory authorities in recent years.

The implementation of rules also requires cooperation from the law enforcement environment. It is worth noting that the "Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery (II)" has been implemented since May 1, 2026. The judicial interpretation clearly states that the crimes of bribery of non-state personnel and bribery of non-state personnel shall be executed in accordance with the conviction and sentencing standards for bribery, bribery, and unit bribery, respectively. This means that the threshold for convicting non-state personnel of bribery and corruption has been adjusted from the previous "double threshold" of 60000 yuan to 30000 yuan.

Fu Xiaoyu stated that under the new regulations and the second judicial interpretation on corruption and bribery officially implemented by the "two highs" on May 1st, practitioners in the pharmaceutical industry must strictly abide by three high-risk red lines: it is strictly prohibited to conduct business cooperation with unregistered pharmaceutical representatives; It is strictly prohibited to disclose medication data in violation of regulations; It is strictly prohibited to accept kickbacks, gifts, inflated teaching fees, and other forms of disguised benefit transmission.

She added that Judicial Interpretation 2 clearly states that bribery crimes in the medical field will be dealt with strictly, and those who accept bribes of up to 30000 yuan will be punished. At the same time, the scope of accountability is extended, and if a spouse, child, or specific related person accepts benefits, the individual will be held accountable simultaneously. The transfer of benefits packaged in compliance will also be considered a crime and must be fully avoided.

While redefining the boundaries of behavior, pharmaceutical representatives also have clearer entry barriers. The Management Measures for Pharmaceutical Representatives stipulate that pharmaceutical representatives should meet the following conditions: have a college diploma or above in medicine, pharmacy, or related majors; Master the knowledge of pharmacology, toxicology, functional indications or indications, combination therapy, adverse reactions, contraindications, and precautions of the promoted drugs; Trained and assessed as qualified by the holder of the drug marketing authorization.

Fu Xiaoyu stated that under the new regulations, the educational qualifications and mandatory training requirements for pharmaceutical representatives will inevitably be raised, accelerating the industry's reshuffling and removal of non compliant personnel. Promote pharmaceutical representatives to shift from sales orientation to academic and professional promotion, reshape their professional image and industry reputation. At the same time, it forces pharmaceutical companies to increase their investment in compliance and professional training, raise barriers to entry, and promote the industry's transformation towards standardization, specialization, and compliance.

Pharmaceutical companies find it difficult to 'throw the blame' again

Pharmaceutical companies can no longer simply blame individual pharmaceutical representatives for their illegal and irregular behavior.

The Measures for the Administration of Pharmaceutical Representatives stipulate that the holder of a drug marketing authorization is responsible for the management of pharmaceutical representatives hired or authorized, strictly regulating the behavior of pharmaceutical representatives, and assuming the main responsibility for the academic promotion activities of pharmaceutical representatives. If the holder of the drug marketing authorization is overseas, the designated domestic responsible person shall fulfill the corresponding responsibilities.

Prior to this, pharmaceutical representatives carried out drug promotion activities under the authorization of pharmaceutical companies. However, once there were illegal or irregular incidents, pharmaceutical companies often blamed frontline personnel for the problem, explaining it as the personal behavior of pharmaceutical representatives or attributing it to the management of outsourced promotion teams or third-party service agencies losing control.

This dilution of responsibility has been one of the difficulties in the compliance governance of pharmaceutical representatives in the past. On the one hand, companies carry out their work through authorization, training, expense budgeting, regional division, and product task arrangements, while on the other hand, they simply claim that this is personal behavior after violations occur, which can easily lead to an asymmetry between management responsibility and commercial benefits.

Such controversies and contradictions were not uncommon before this. One of the family members of the pharmaceutical representative involved in the case told Interface News that her husband was only implementing the company's established sales strategy, but was investigated and found to be involved in fraud amounting to 60 million yuan. There is no additional income that should not be received other than the regular salary and bonuses paid by the company.

Fu Xiaoyu told Jiemian News that it is clear that the holder of the drug marketing authorization is the first person responsible for the management of pharmaceutical representatives, and the responsibility boundary is no longer limited to filing and registration, but covers the entire life cycle of pharmaceutical representative admission and employment, compliance training, behavior supervision, promotion management, illegal exit, and industry ban, thoroughly consolidating the responsibility of enterprise source management.

Pharmaceutical companies can no longer solely blame third-party organizations for any illegal or irregular practices in outsourcing promotion.

The Measures for the Administration of Pharmaceutical Representatives stipulate that if the holder of a drug marketing authorization entrusts a professional organization to carry out drug academic promotion activities, the trustee's ability should be evaluated, compliance requirements and violation responsibilities should be agreed upon, a pharmaceutical representative management agreement should be signed, and an authorization letter should be signed with the pharmaceutical representative who carries out drug academic promotion activities for them.

Prior to this, there was a widespread model of cooperation in the industry through contract sales organizations, consulting service agencies, digital marketing platforms, as well as third-party organizations such as foundations, societies, and associations. As long as the relevant academic promotion activities fall within the scope of enterprise drug promotion, even if the specific activities are implemented by third-party organizations, the drug marketing authorization holder still needs to bear management responsibilities.

There were many gray areas among them. Interface News has reported on the "Medical Anti Corruption Storm" series. Provide a detailed explanation of how industry associations, foundations, and academic conferences become channels for transferring benefits.

An industry insider who cannot be named told Interface News, "In this case, the pharmaceutical company and the foundation sign a donation agreement, and the foundation only charges 10-15% of the project management fee on the surface, and the remaining fees will be used for the project. In fact, for example, if a patient management project is implemented by Company A, the foundation will sign an execution contract with the executing party and pay according to the agreement. There are two ways to give this money to doctors: one is for the foundation to directly pay the doctors in the name of labor fees. Another approach is to unify the fees to the executing company, which will then pay the doctors. Generally speaking, the method of direct payment by foundations is more commonly used. ?As for whether the project has actually been implemented, it is unknown.

The same "trick" is for pharmaceutical companies to sponsor industry associations or societies. Another industry insider told Interface News, "For compliance reasons, if a certain amount of money cannot be paid to a hospital or expert, the association will be approached to package a project. The association will charge 10% to 20% of the entire project funds as management fees, and the remaining project funds can be borrowed from the project name and given to the hospital or expert, which is equivalent to giving this money a compliant skin

Fu Xiaoyu stated that in response to the commonly used contract sales organization promotion services, consulting services, digital marketing platforms, and even third-party cooperation models such as foundations and academic associations in the industry, the new regulations release clear regulatory signals that pharmaceutical companies cannot completely isolate compliance risks with third-party responsibilities.

She stated that the new regulations clearly stipulate that holders bear the main responsibility for pharmaceutical representatives (including contract sales organization personnel) and must establish a full process management system. Regulatory authorities may directly pursue the responsibility of pharmaceutical companies through contract sales organizations, unless the companies can prove that they have fulfilled their compliance management obligations.