On April 11, the National Medical Products Administration (NMPA) issued the "Administrative Provisions on Drug Annual Reporting" and explicitly stipulated that it would take effect from the date of issuance.

According to Articles 37 and 38 of Chapter III (Marketing Authorization Holders) of the "Drug Administration Law of the People's Republic of China," which was revised in 2019 and came into effect that same year, a drug marketing authorization holder (MAH) shall establish an annual reporting system and report information annually on drug manufacturing and distribution, post-marketing research, risk management, and other aspects to the drug administrative department of the province, autonomous region, or municipality directly under the central government, as per regulations. If the MAH is an overseas enterprise, a legally established enterprise legal entity within China designated by it shall fulfill the obligations of the MAH and bear joint liability with the MAH.

The "Administrative Provisions on Drug Annual Reporting" issued this time formally clarifies the implementation requirements of this legal provision. The NMPA organized the development of the "Administrative Provisions on Drug Annual Reporting" and the "Template for Drug Annual Report." Additionally, to ensure the implementation of the drug annual reporting system, the NMPA developed a Drug Annual Report Collection Module, which was launched concurrently.

To facilitate reporting by MAHs, the newly established Drug Annual Report Collection Module directly interfaces with key information from the drug regulatory data sharing platform, such as drug registration and drug manufacturing licenses. This enables automatic population of critical foundational data, helping to improve the accuracy of the information submitted. Going forward, leveraging the advantages of the National Drug Regulatory Data Sharing Platform, annual report information will gradually be integrated into drug product files and drug safety credit files, solidifying the information foundation for smart drug regulation.

The Drug Annual Report Collection Module consists of an enterprise terminal and a regulatory terminal. The information collected via the enterprise terminal includes two parts: public information and product-specific information. The public information section encompasses six areas: MAH information, overall information on held products, quality management overview, pharmacovigilance system establishment and operation status, acceptance of entrusted manufacturing from overseas entities, and inspections by overseas drug regulatory authorities. The product-specific information section includes four areas: basic product information, production and distribution status, post-marketing research and change management status, and risk management status. After an MAH completes and submits the drug annual report, the provincial drug regulatory department can view the annual report information of MAHs within its administrative region through the regulatory terminal.

Given that this is the first implementation of the drug annual reporting system in China and the collection module is currently in a trial operation phase, the deadline for submitting the 2021 annual report information is August 31, 2022. Starting next year, the annual report information for the preceding year must be submitted by April 30th each year.

Notice of the National Medical Products Administration on Issuing the "Administrative Provisions on Drug Annual Reporting"

Guo Yao Jian Yao Guan [2022] No. 16

To the Drug Administrations of all provinces, autonomous regions, and municipalities directly under the central government, as well as the Xinjiang Production and Construction Corps:

To implement the relevant requirements of the "Drug Administration Law," the "Drug Registration Regulations," and the "Drug Production Supervision and Administration Measures," and to further guide drug marketing authorization holders (hereinafter referred to as MAHs) in establishing an annual reporting system, the National Medical Products Administration (NMPA) has organized the development of the "Administrative Provisions on Drug Annual Reporting" (see Attachment 1) and the "Template for Drug Annual Report" (see Attachment 2), which are hereby issued. Additionally, to ensure the implementation of the drug annual reporting system, the NMPA has developed a Drug Annual Report Collection Module, which is launched concurrently. Relevant matters are notified as follows:

I. Supervise and Urge MAHs to Fulfill Their Primary Responsibility for Drug Annual Reporting

The drug annual reporting system is a new system introduced by the "Drug Administration Law." The "Drug Administration Law" clearly stipulates that drug MAHs shall establish an annual reporting system and report information annually on drug manufacturing and distribution, post-marketing research, risk management, and other aspects to the drug administrative department of the province, autonomous region, or municipality directly under the central government, as per regulations. The MAH is the entity responsible for submitting the annual report; if the MAH is an overseas enterprise, the enterprise legal entity legally designated by it within China that bears joint liability shall fulfill the obligation of submitting the annual report.

Provincial drug regulatory departments shall strengthen policy publicity, supervision, and guidance, and further urge MAHs to fulfill their primary responsibility for quality management throughout the product lifecycle by standardizing their annual reporting practices. MAHs shall leverage the annual report as a tool to enhance their sense of primary responsibility, proactively improve their management capabilities, and enhance their own management levels. MAHs shall designate dedicated personnel responsible for annual reporting, improve internal reporting management procedures, strictly review the content of annual reports, and ensure that the submitted information is truthful, accurate, complete, and traceable.

II. Effectively Promote Data Sharing and Information Utilization

The NMPA has developed the Drug Annual Report Collection Module. To facilitate reporting by MAHs, this module directly interfaces with key information from the drug regulatory data sharing platform, such as drug registration and drug manufacturing licenses. This enables automatic population of critical foundational data, helping to improve the accuracy of the information submitted. Going forward, leveraging the advantages of the National Drug Regulatory Data Sharing Platform, annual report information will gradually be integrated into drug product files and drug safety credit files, solidifying the information foundation for smart drug regulation.

Provincial drug regulatory departments shall use the annual report information as reference material and a basis for analysis in inspection, risk assessment, credit supervision, and other activities, gradually achieving precise and scientific regulation and enhancing the efficiency of drug lifecycle supervision. Concurrently, based on work arrangements such as inspections, provincial drug regulatory departments shall review the content of MAHs' annual reports, investigate and penalize MAHs that fail to submit annual reports in accordance with regulations, and include such information in the drug safety credit files.

III. Fully Ensure the Operation and Maintenance of the Annual Report Collection Module

The Drug Annual Report Collection Module consists of an enterprise terminal and a regulatory terminal. The information collected via the enterprise terminal includes two parts: public information and product-specific information. The public information section encompasses six areas: MAH information, overall information on held products, quality management overview, pharmacovigilance system establishment and operation status, acceptance of entrusted manufacturing from overseas entities, and inspections by overseas drug regulatory authorities. The product-specific information section includes four areas: basic product information, production and distribution status, post-marketing research and change management status, and risk management status. After an MAH completes and submits the drug annual report, the provincial drug regulatory department can view the annual report information of MAHs within its administrative region through the regulatory terminal.

The Information Center of the NMPA shall provide technical support after the module goes live. The procedures for activating permissions and operating the enterprise and regulatory terminals can be found in the operation manuals (see Attachments 3 and 4). The latest electronic version of the operation manuals can be downloaded from the system. If users encounter any issues while using the system, they may contact the technical support hotline (4006676909 ext. 2) or communicate via the designated QQ work groups (Regulatory users: 320404770; Enterprise users: 282253676).

IV. Other Matters

1. These Provisions take effect from the date of issuance, and the Drug Annual Report Collection Module is launched simultaneously.

2. Given that this is the first implementation of the drug annual reporting system in China and the collection module is currently in a trial operation phase, the deadline for submitting the 2021 annual report information is August 31, 2022. Starting next year, the annual report information for the preceding year must be submitted by April 30th each year.