持有人报药品年度报告是《药品管理法》规定的：
第三十七条 药品上市许可持有人应当建立年度报告制度，每年将药品生产销售、上市后研究、风险管理等情况按照规定向省、自治区、直辖市人民政府药品监督管理部门报告。

NMPA Releases Draft Regulations and Template for Public Comment

To implement the annual reporting requirements of the Drug Administration Law and the Vaccine Administration Law, the NMPA has drafted the Drug Annual Report Management Regulations (Draft for Comments) and the Drug Annual Report Template (Draft for Comments). Comments can be submitted via email to ypjgs@nmpa.gov.cn by December 22, 2020.

Key Provisions of the Draft Regulations (Simplified):

Applicable Entities: Marketing authorization holders (MAHs) must establish and implement an annual reporting system. For overseas MAHs, the designated legal entity in China fulfills this obligation. TCM decoction piece manufacturers are also required to comply.

Reporting Deadline: Reports must be submitted annually by March 31 via the designated information system. Corrections are allowed before the deadline; after that, reports cannot be modified.

Content of Annual Report:
1. Basic Information: Holder details, production license, production addresses.
2. Product Information: Production and sales data (domestic and overseas), post-marketing research, risk management.

Post-Marketing Research: Includes conditional approval studies, generic drug consistency evaluation, post-approval changes (approved/filed/minor), and other changes required by the NMPA. Adverse reaction data is reported separately.

Risk Management: Includes investigation and handling of non-conforming batches, product recalls, risk control measures, and other required reports.

Supervision: Provincial drug authorities oversee and inspect compliance. For cross-provincial arrangements, the province where the contract manufacturer is located will review production-related content.

Penalties for Non-Compliance: Failure to submit the annual report may result in a warning and a 20-day deadline for correction. Continued non-compliance may incur a fine of RMB 100,000 to 500,000.

Effective Date: To be determined.