According to the relevant provisions of the Regulation of the People's Republic of China on the Disclosure of Government Information , this annual report is prepared based on the actual information disclosure situation of the Center for Food and Drug Inspection of NMPA in 2019. The report includes the general situation, the construction of the information disclosure platform, the active disclosure of information, the handling of consultations and complaints, major issues and improvement measures. The statistical period of the data included in this report is from January 1, 2019 to December 31, 2019.

If you have any questions about this report, please contact the Information Management Office of the Center for Food and Drug Inspection of NMPA (Address: 7/F, Bei Kuang Financial Building, Building 3, No. 1, Wenxing Street, Xicheng District, Beijing; postcode: 100044; Tel: 010-68441187).

I. Overview

In 2019, CFDI strengthened the construction of information platform, integrated the function of administration services, added some columns, enhanced information disclosure in key fields and continuously improved disclosure quality in accordance with the requirements of the Regulation of the People's Republic of China on the Disclosure of Government Information , the Guidelines for the Development of Government Websites , as well as the 2019 Evaluation Indicators for the Websites Directly under the National Medical Products Administration .

II. Construction of information disclosure platform

(i) Chinese and English websites

As of December 31, 2019, a total of 50 columns had been created on the Chinese website, including 6 for important dynamic news, 13 for notice information, 1 for policies and regulations, 8 for data query, 10 for special subjects, 1 for institutional function, 3 for interactive communication, and 8 for administration services. The English website has 6 columns, including 3 dynamic news columns, 1 institutional function column, and 2 policy and regulation columns.

The homepage of the website of CFDI

The homepage of the English website

1.In order to implement the information disclosure requirements of the Drug Administration Law and better serve drug registration applicants, column for inspection tasks and column for medical device inspection were added on CFDI’s website in the year 2019 (given below). Inspections on drug registration application to be launched by CFDI were regularly announced to remind applicants to get prepared.

2. The responses to online consultation were displayed by different categories (including on-site inspection on drug non-clinical study, on-site inspection on clinical trials of medical devices, on-site inspection on Chinese drug production, on-site inspection on the field for biological product manufacturing, on-site inspection on the field for medical device manufacturing, on-site inspection on the field for cosmetics development and production, on-site inspection on food manufacturing, etc.), which facilitated query about similar questions.

3. Under the online administration column, online application, online submission, online appointment, etc. were integrated into the one for business guide. The original columns and content remained unaltered so that users could handle affairs from different columns with ease.

4. Two sections, i.e. clinical trial data verification and on-site inspection on the production field of chemical generic injection, were added to the column for laws and regulations; consistency evaluation and guiding principles on the home page of the website were transferred to the column as sub-topics; data reliability column was canceled. Following this, the layout of the home page was adjusted accordingly.

5. On the home page, online survey column was added, with focus on CFDI’s inspection work and information disclosure, among others. Public opinions and suggestions were collected via online survey to further improve CFDI's comprehensive ability and better serve the public.

6. CFDI improved disclosure of institutional functions and made available the contact information (including email, address, postcode, phone number, etc.) in the left corner of the introduction column for the convenience of the public. At the bottom of the web page, the general number and fax number of CFDI were added.

7. The online search results were displayed by class, and a prompt about the column where the information is classified was sent, which was convenient for query about similar questions.

8. For information provision via online consultation, complaint, appointment, etc., security verification function was added to prevent malicious batch operation and improve website security.

In 2019, the Chinese and English websites were visited for 4.42 million times, an increase of 21% over 2018.

(ii) WeChat Official Account

As of December 31, 2019, the WeChat official account titled CFDI Inspection and Verification had 3 sections composed of 15 columns, including 1 dynamic news column, 3 bulletin information columns, 3 policy and regulation columns, 4 special topic columns, 3 institutional function columns and 1 service column. From the launch on December 6, 2016 to December 31, 2019, followers exceeded 30,000, of which 5,763 were added in the year 2019.

WeChat official account 's QR code display

The number of fans of the WeChat official account

(iii) Display system

In 2019, as a result of work adjustment, the contents of the display & inquiry machine in the reception room were updated to ensure the consistency with the website and to provide accurate and reliable information for visitors.

III. Active disclosure of information

(i) Further improving the relevant systems

CFDI revised and published the Procedures for Website Information Release, and the Procedures for Information Release and Management on WeChat Official Account to regulate the management of information collection, entry and use to ensure the accurate, timely and effective disclosure of information.

(ii) Strengthening active disclosure

From January 1 to December 31, 2019, the Chinese website totally disclosed 2,370 pieces of information, with a 82% increase compared to 2018, including 701 pieces of news & announcements, 1,662 for announcements about key areas, 7 about policies & regulations and work procedure. The English website published 16 pieces of information.

The overall situation of information disclosure on the website of CFDI

(iii) Strengthening the information disclosure in key areas

In 2019, a total of 6 public announcements were released, including one about the specifications for quality control of drug non-clinical studies, one about the inspection on the qualification of clinical trial institutions, and 4 about on-site verification plan of drug clinical trial data.

A total of 126 pieces of NMPA’s hot spot information were released and forwarded by the columns for on-site inspection on the production field of chemical generic injection, inspection tasks, medical device inspection, clinical trial data verification, flight/tracking inspection, overseas inspection, as well as inspection plan.

A total of 1,530 advance notices and announcements about on-site inspection/verification, including 490 about on-site inspection on drug production, 46 about GLP on-site inspection, and 994 about on-site inspection on drug clinical trial data.

(iv) Maintaining related query databases.

In 2019, CFDI continued to maintain the existing databases, and supplemented the announcements on drug non-clinical study specifications and certification and on qualification of and inspection on drug clinical trials. As of December 31, 2019, CFDI totally opened 5 announcement inquiry databases to the public, with a data volume of 23429, including 20,588 GMP certification announcements, 176 TCM GAP inspection announcements, 118 non-clinical drug trial quality control certification announcements, 971 clinical drug trial qualification affirmation inspection announcements; and 1,576 GMP certification review data announcements.

(v) Continued to improve the quality of information published through the WeChat official account

As of December 31, 2019, the official account had pushed information for 484 times and released 1,097 pieces of information, with 910,000 readers and 1.96 million views in total. In 2019, a total of 118 messages were pushed, 207 were published, with 255,645 viewers and 368,409 views. One piece of information was viewed by 20,845 readers at maximum, which reached a high record. Compared to 2018, views per piece increased by 46% on average.

By information column, the number of information released in main columns in 2019 is as follows: 66 pieces of information about regulatory penalties, 43 about dynamic inspection news, 31 about inspection research, 21 about inspection plans, 14 about regulatory policies, 12 about comments seeking, 12 about inspection announcements, 7 about annual report and one about other information. Compared with 2018, the proportion of regulatory penalties shrank, while that of real-time inspection conditions, inspection research, inspection plans, etc. increased.

Information release volume of the columns on the WeChat official account

IV. Handling of consultations and complaints

(i) On-line consultations

In 2019, a total of 771 on-line consultations were received, including 708 valid consultations, up 5.8% over 2018, and 63 invalid consultations due to incomplete or unclear description. A total of 371 valid consultations were answered, representing a response rate of 52%, of which 80 consultations were related to drug production, CFDI’s administration services and other common issues (or issues with great attention) were released on the website and 189 consultations about general issues were answered by email or SMS.

(ii) On-line complaints and handling

In 2019, a total of 19 complaints were received, including 8 valid complaints, down by 77% than that of 2018, and 11 invalid complaints. Most of invalid complaints were repeated or described vaguely, which made solution impossible. Among the valid complaints, 6 complaints were out of the functional scope of CFDI and so have been transferred to the NMPA Administrative Issues Acceptance and Complaints Reporting Center and 2 complaints involving the inspections of CFDI were transferred to the business departments of CFDI for processing. The handling rate of complaints and reports was 100%.

(iii) Online survey.

Online survey column was launched on September 25, 2019 to collect public opinions and suggestions on the website and improve the quality of services such as website information disclosure. As of December 31, 2019, CFDI had not received survey feedbacks.

(iv) Online appointment

In 2019, 937 pieces of online appointment information were received in total, and CFDI timely processed and assigned them to corresponding departments or offices, and completed on-site communication.

V. Main issues and improvement measures

In 2019, CFDI has achieved significant results in highlighting information disclosure in key areas and improving the pertinence, timeliness, and effectiveness of public information. However, considering the new situation and requirements of drug supervision and inspection, problems and defects still existed in information disclosure. There was room for improvement in terms of positive disclosure, response to public consultations and service quality. In 2020, CFDI will further focus on the following tasks in accordance with the relevant requirements of the Regulation of the People's Republic of China on the Disclosure of Government Information and the National Medical Products Administration:

(i) Strengthening the construction of information disclosure platform.

CFDI will, based on the on-site inspection requirements, build an information platform with the focus on serving applicants for drug registration, known as Window for Applicants. The platform will support online services and information disclosure, including inspection on application submission, check on on-site inspection notices, defects and inspection progress, as well as inspection records search, which can upgrade level of informatization for inspection work.

(ii) Strengthening active disclosure

With focus on the implementation of new laws such as the Drug Administration Law, Vaccine Administration Law, Measures for the Administration of Drug Registration, and Measures for Supervision and Administration of Drug Production, CFDI will step up efforts in promoting inspection policies and actively disclose information in key areas.

(iii) Strengthening information release management.

CFDI will enhance the standardized management of released information, further refine information disclosure and improve its efficiency and quality.

Appendix: 2019 Information Disclosure Statistics.docx

Center for Food and Drug Inspection of NMPA

March 17, 2020