The Comprehensive Department of the State Drug Administration issued a notice on the activation of the API production and supply information collection module

The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps: In accordance with the "Opinions of the General Office of the State Council on Further Doing a Good Job in Maintaining Supply and Stabilizing Prices of Drugs in Shortage" (Guobanfa [2019] No.
47), " The Announcement of the State Food and Drug Administration on Further Improving the Related Matters Concerning Drug-related Review, Approval, and Supervision Work (No.
56 of 2019) related to the relevant requirements.
The drug information collection platform has developed and constructed a raw material drug production and supply information collection module
.
This module was officially launched on the date of issuance of this notice
.
The relevant matters are hereby notified as follows: 1.
Brief introduction of functions The API production and supply information collection module is divided into the enterprise side and the supervisory side
.
The enterprise side mainly provides information filling, modification, deletion and submission functions.
It collects the production, supply and inventory information of APIs that have passed the associated review and approval on a quarterly basis.
The production information includes the variety name, batch number, production date, storage date, expiration date, and production quantity storage; supply information including name of the variety, batch number, purchase business name, where the provinces, such as the number of sales; inventory information includes the variety name, batch number, production date, expiry date, number of stocks
.
The supervisory end mainly provides query functions, and each provincial drug supervisory authority can inquire about the production and supply information of APIs according to their authority
.
The information collection module requires a registered account to log in
.
If you have an account in the online service hall of the National Medical Products Administration (enterprise users) or the National Smart Drug Supervision Platform (supervised users), you must authorize the binding of the drug business application system before proceeding with related business processing; if there is no corresponding account, Please register users in the online service hall of the National Medical Products Administration (enterprise users) or the National Smart Drug Supervision Platform (supervised users), and authorize the binding of the drug business application system before proceeding with related business processing
.
For details, please refer to the operation manuals in Annex 1 and Annex 2
.
2.
Filling in requirements In order to steadily promote the use of this module, we now determine the work arrangements for sub-category and step-by-step implementation
.
From the third quarter of 2021, the production and supply information of raw materials for all drugs included in the "National List of Shortage Drugs" and "National Key Monitoring List of Clinically Necessary and Easily Shortage Drugs" will be included in the scope of collection
.
In the future, according to the needs of drug regulatory work, the State Drug Administration will expand the range of APIs collected by this module as appropriate
.
At this stage, companies can voluntarily fill in and submit information on the production and supply of other types of APIs
.
Relevant API manufacturers shall fill in their API production and supply information through the API production and supply information collection module, and submit it online to the provincial drug supervision and administration department where the API manufacturers are located
.
If the manufacturing company is an overseas company, the legal person designated by it in China shall fill in the report on its behalf, and submit it online to the provincial drug regulatory authority where the company is located
.
The reporting unit shall be responsible for the accuracy, comprehensiveness and completeness of the information reported
.
The information on the production and supply of raw materials can be used for inquiries by drug regulatory authorities
.
Relevant API manufacturers are requested to supplement their API production and supply information for the third quarter of 2021 before the end of November 2021
.
After that, relevant API manufacturers should fill in the last quarter's API production and supply information before the 20th of the first month of each quarter
.
For the raw material drug production and supply information that has not been submitted formally or submitted within 10 days, the reporting unit can modify and delete it by itself; if the information is submitted more than 10 days, the reason can be modified before it can be modified, but the information is not allowed to be deleted
.
3.
Work requirements Each provincial-level drug regulatory department is responsible for organizing and carrying out the information filling and reporting of the production and supply of raw materials in the administrative area
.
It is necessary to strengthen organizational leadership and policy publicity, improve work measures, clarify specific personnel, and guide API manufacturers to familiarize themselves with module functions as soon as possible, complete account registration, and fill in relevant information in a timely manner as required
.
The Information Center of the State Drug Administration shall do a good job of technical support after the module is online
.
Please refer to the operation manual (see Annex 1 and Annex 2 for details) for the permission opening and operation process of the enterprise and supervisory ends of this module
.
The electronic version of the operating manual can be downloaded from the system
.
If users find problems during the use of the system, they can contact the technical support customer service hotline (4006676909 ext.
2) at any time; they can also join the QQ work group (supervised users: 320404770; corporate users: 282253676) for communication and resolution
.
Attachment: 1.
Enterprise-side operation manual of API production and supply information collection module 2.
Supervision-side operation manual of API production and supply information collection module, National Food and Drug Administration, November 1, 2021