Big Data for Intelligent Regulation Helps with the NMPA’s Work

  • 2021-08-24
The reporter has recently learned from the Information Center of NMPA (hereinafter referred to as the Information Center) that the Unique Device Identification (UDI) Service Public Platform (hereinafter referred to as the Platform) has received the attention of many medical institutions, especially those participating in the UDI pilot program. More than 200 medical institutions have registered on the Platform, 168 of which have conducted data standardized management, qualification management, and matching services using the Platform. The Platform has conducted matching for accumulated 211,408 pieces of basic data.

“The Platform provides strong support to promote the effective implementation of the UDI system,” said Guo Yuanyuan, Head of the Application System Division II of the Information Center. To explore and advance the implementation and application of UDI in medical institutions and help medical institutions solve difficult issues such as medical device product data matching and non-standardized basic data, the Information Center and Huake Pharmaceutical Intellectual Property Consultative Center jointly researched the project Advancement of Unique Device Identification Work - Research on UDI Application in Medical Institutions in association with China National Medical Device Co., Ltd., and they built the Platform and launched it online in March this year to provide public service for medical institutions at all levels in China.

The Platform contains three core functions: data standardization, UDI-DI (DI for medical device product identifiers) matching, and medical device qualification management. The UDI-DI matching module can help medical institutions match internal codes with national UDI database DIs and add DI field information in their data dictionaries so that by scanning the UDI on medical device packaging, the important information related to product identification in the national UDI database can be automatically read, thus reducing manual entry and realizing the use of UDI to link whole-chain information from procurement, warehousing, clinical use, billing, adverse event monitoring, to medical insurance settlement, to greatly improve hospital consumable management effectiveness and promote the integration of medical treatment, medical insurance and medicines supply.

Since March this year, the research group has conducted 21 sessions of training in UDI and Platform usage in Beijing, Tianjin, Hainan, Zhejiang, Fujian, Shandong, Hunan, Jiangxi, etc., with more than 1,500 persons trained.

The construction of the Platform is only an epitome of the NMPA’s efforts to build big data for intelligent drug regulation. The reporter learned that the NMPA continues to increase the disclosure of drug review information to effectively improve regulatory effectiveness and people’s sense of gain. The website of the Center for Drug Evaluation, NMPA (hereinafter referred to as the “CDE”) has columns such as priority review publicity, breakthrough therapy publicity, communication and exchange publicity, and marketed drug information, to disclose information on varieties which applicants and the public pay high attention to and are included in the priority review procedures as well as information on drugs approved for marketing. At the same time, the “Window for Applicants” directionally discloses review progress, review inquiries, review conclusions, supplementary information notices, etc. to applications. According to statistics, the CDE has so far officially released 1,289 pieces of information on varieties included in the priority review and approval procedures, 67 pieces of information on varieties included in the breakthrough therapy procedures, 434 new drug technical review reports, 940 pieces of information on the passing of generic drug quality and efficacy consistency evaluation (calculated according to the acceptance numbers), etc.

The disclosure of all the information has not only facilitated applicants and the public to comprehensively understand the situation of Chinese drug varieties whose registration applications are included in the priority procedures but also promoted the openness and transparency of drug review work information.

An industry insider told the reporter that priority review and breakthrough therapy publicity information allows enterprises to understand the R&D directions encouraged by the state or regulatory authorities, while marketed drug information allows enterprises to understand the review standards and assessment criteria for drug marketing, so as to avoid detours in future R&D.

It is learned that the NMPA is also becoming more open in terms of medical device review information disclosure. The Center for Medical Device Evaluation, NMPA discloses medical device registration application process and progress, Class III medical device technical guidelines, technical review reports on innovative medical devices and medical devices included in priority review to the public and accepts social supervision.

Furthermore, to broaden the information interaction channel with applicants, the Center for Food and Drug Inspection of NMPA (“CFDI”) has improved the “Window for Drug Registration Applicants”. The website of the CFDI has so far set up modules including inspections of drug registration on production sites, inspections of development of varieties subject to generic drug quality and efficacy consistency evaluations on production sites, inspections of chemical generic injection registration on production sites, inspections of drug clinical trial data, inspections of clinical trial data for consistency evaluations, and inspections of pharmacology and toxicology registration, and the website also provides notifications, progress inquiries, file interaction, historical inspections queries, and other functions, to improve the quality and efficiency of drug registration inspections.

In the future, the NMPA will continue to promote the construction of related projects for disclosing data and enhancing the public’s sense of gain, for example, the China Center for Food and Drug International Exchange (“CCFDIE”) plans to collect, sort out and edit pharmaceutical information such as policies, regulations, and announcements issued by the drug regulatory system, provide them in Chinese and English versions, and simultaneously publish them on the English website of the NMPA and the website of the CCFDIE.

Source: China Pharmaceutical News