The National Medical Products Administration ("NMPA") issued the Administrative Provisions on Drug Annual Reporting (“Provisions”) on 11 April 2022, which took effect on the same day.
The Provisions implement drug annual reporting required by the Drug Administration Law (effective as of 1 December 2019) (Article 37), the Administrative Measures for Drug Registration (effective as of 1 July 2020) (Article 80), and the Measures for the Supervision and Administration of Drug Production (effective as of 1 July 2020)(Article 39). The Provisions also intend to further guide drug market authorization holders (“MAH holders”) to establish annual reporting system. The NMPA has built a collection module1 for drug annual reporting, which is activated at the same time as coming into effect of the Provisions.
Together with the Provisions, the NMPA also issued a Circular regarding Issuing the Administrative Provisions on Drug Annual Reporting (2022 No.16) (“Circular”). According to the Circular, due to the reason that drug annual reporting system is implemented for the first time in China, and that drug annual report collection module is still in trial operation stage, the time limit for submission of the 2021 annual report information is 31 August 2022. Starting from the year 2023, annual report information of the previous year shall be filled in before 30 April every year.
Apart from the Provisions, the Circular published three other accessory documents related to drug annual reporting:
- Drug Annual Reports Template (2022 Version);
- Operation Manual for Collection Module of Drug Annual Reporting (for Enterprises);
- Operation Manual for Collection Module of Drug Annual Reporting (for Regulators);
The main content of the Provisions is described as below:
1. Responsible Entity
Articles 3 and 4 of the Provisions provide that MAH holders are the responsible parties for drug annual reporting and they shall establish a system of establishment, filling and management of annual reports. If an MAH holder is an overseas enterprise, a domestic enterprise legal person designated by the MAH holder according to the law and which bears joint and several liability with the MAH holder within the territory of China shall perform the annual reporting obligation.
2. Content of the Annual Report
Article 9 of the Provisions provides that an annual report shall be divided into public part and product part.
2.1 Public Part of the Report
Public part shall include:
- MAH holder's information,
- general information of the product held by the MAH holder,
- overview of quality management,
- establishment and operation of the pharmacovigilance system,
- acceptance of overseas commissioned processing, and
- acceptance of inspections by overseas drug regulatory agencies.
2.2 Product Part of the Report
Product part shall include:
- basic product information,
- production and sales,
- post-market research and change management, and
- risk management.
Article 10 of the Provisions further provides that information on the production and sales of drugs shall include the status of domestic production, import quantity and domestic and overseas sales of various specifications of the same variety of drugs.
Article 11 of the Provisions further provides that information on post-market research and change management shall include the following content:
(a) post-market research conducted in accordance with drug approval documents and requirements of drug administrative authorities;
(b) information on changes of drugs subject to approval that have been approved, changes subject to filing and those subject to reporting;
(c) review and evaluation of quality of Chinese Traditional Medicines used in the production of Chinese herbal decoction pieces, and the verification of processing or production process changes;
(d) other circumstances that need to be reported.
Article 12 of the Provisions further provides that information on risk management shall include the following contents of domestically marketed drugs:
(a) post-market risk management plan of drugs;
(b) information on investigation and handling of products that do not meet drug standards;
(c) returns, recalls, etc. caused by quality issues or other potential safety hazards;
(d) production, sales, risk management, etc. of commercial-scale batches of drugs that have passed corresponding good manufacturing practice compliance inspection before drugs are put into market;
(e) other circumstances that need to be reported.
3. Time Limit for Submitting the Annual Report
Except for the annual report of the year 2021 which shall be submitted before 31 August 2022, Articles 6 and 8 of the Provisions provide that an MAH holder shall prepare a drug annual report according to the drug annual report template and submit it through the drug annual reporting system before 30 April each year.
4. Inspection by Drug Administrative Authorities
Articles 13 and 14 of the Provisions provide that drug administrative authorities shall inspect the situation of establishment and implementation of MAH holders' annual reporting system, and record inspection results in their inspection report. In case of any non-conformity with PRC laws and regulations and the Provisions, provincial-level drug administrative authorities can order the MAH holder to effect rectification and supplement or correct the information in its annual report within 20 working days. If the MAH holder is unable to carry out rectification within the said time limit, it shall formulate a feasible rectification plan and submit it to provincial-level drug administrative authorities.
Article 16 of the Provisions further provides that in case an MAH holder fails to submit its annual report, it shall be punished in accordance with Article 127 of the Drug Administration Law, i.e. corrections within a prescribed time limit and warning; and in the case of failure to make corrections within the prescribed time limit, a fine of not less than RMB 100,000 but not more than RMB 500,000.
MAH holders for drugs shall follow the Provisions and the accessory documents to the Circular and prepare and submit drug annual reports accordingly within the statutory time limit.
1Online system of NMPA for collection of drug annual reports from MAH holders, which can be accessible via the website (https://zwfw.nmpa.gov.cn/web/index). Please refer to the accessory document of the Circular (as mentioned herein) Operation Manual for Collection Module of Annual Reports on Drugs (for Enterprises) for details.