In accordance with relevant provisions of the Regulations of the People's Republic of China on the Disclosure of Government Information and in combination with actual situations of the information disclosure of CFDI in 2021, this annual report has been formulated. This report covers an overview, online office service platform, system construction, information disclosure in key areas, construction of website and new media platform, consultation and complaints, problems and improvements, and other aspects. The data listed in this report was summarized from January 1, 2021 to December 31, 2021.

If you have any questions about this report, please contact the Department of Information Management of CFDI (Address: Floor 7, Beikuang Finance Building, Building 3, Yard 1, Wenxing Street, Xicheng District, Beijing; Postal code: 100044; Tel: 010-68441191).

I. Overview

In 2021, CFDI further enhanced the construction of information disclosure platform, improved service functions, strengthened information disclosure in key areas, and constantly improved the quality of information disclosure according to the Regulations of the People's Republic of China on the Disclosure of Government Information and Notice on Website Evaluation of Directly Affiliated Institutions in 2021 issued by the National Medical Products Administration (NMPA).

II. Optimization of the Online Service Platform

On January 1, 2021, the online service platform of the Center-Window of Drug Registration Applicants was officially put into operation. The "Window of Drug Registration Applicants" integrates six inspection categories including on-site production inspection for drug registration, on-site production inspection for registration of chemical generic drug- injectable products, on-site development/production inspection for consistency evaluation, and inspection of drug clinical trial data, inspection of clinical trial data for consistency evaluation, pharmacology and toxicology inspection for registration. The function covers notification viewing, progress query, file interchange and query of previous inspections, etc. In 2021, CFDI never stopped optimizing and enhancing the convenience and security of the platform. As of December 31, 2021, a total of 2,229 users completed registration at the Window of Drug Registration Applicants.

III. Further Improvement of the Information Disclosure System

In 2021, CFDI revised the Procedures for the Website Management and further boosted the construction and management of the website. Information was disclosed and issued strictly in accordance with the Procedures for Information Release on the Website of CFDI and Information Release on the WeChat Official Account of CFDI , so as to make sure the information was accurately, timely, standardly and effectively publicized and disclosed.

IV. Disclosure of the Information on Key Business Inspection

In 2021, CFDI had issued 18 announcements on the inspection plan of clinical trial data of drugs and 164 pieces of thematic information and special column information about on-site inspection plan for pharmaceutical development/production, information on cosmetics inspection, and notices of unannounced inspections of medical devices.

V. Constant Acceleration of Website and New Media Platform Construction

(I) New special columns

1. CFDI set up a special column themed on "Set Sail for A New Journey Following A Centennial Struggle - A History of the Communist Party of China" where 235 pieces of information had been forwarded and published.

2. CFDI set up a special column for cosmetics inspection where 57 pieces of information on cosmetics laws and regulations, supervision and inspection, and popular science knowledge had been forwarded and published.

(II) Easier inquiry

In order to improve the convenience of inquiry, CFDI added the original text link of the setting basis at the service column of the website for a better view of the original text and re-edited the keywords of the label columns on the website to effectively reflect the characteristics or functions of the column to facilitate public access.

(III) Column adjustment

In order to improve the practicability of website information, CFDI adjusted and integrated the columns with few updates. In addition, for better inquiring historical information, the columns without updates due to the termination of events were moved to historical columns.

(IV) Website-related data

As of December 31, 2021, there were 42 columns set on the Chinese website, including 6 dynamic news columns, 9 announcement information columns, 1 column for policies and regulations, 5 columns for data query, 11 columns for special topics, 1 column for institutional functions, 4 interactive exchange columns and 5 service columns. There were 6 columns set on the English website, including 3 dynamic news columns, 1 column for institutional functions and 2 columns for policies and regulations.

In 2021, a total of 1,213 pieces of information were actively disclosed on the Chinese website. Among them, there were 1,016 pieces of news releases, 182 pieces of announcements in key areas, and 15 pieces of information on policies, regulations and work procedures. There were 16 pieces of information released on the English website.

In 2021, Chinese and English websites received 5.04 million page views.

(V) Data on WeChat Official Account

The WeChat official account “CFDI Inspection Window” has 14 information categories, including 1 dynamic news column, 3 announcement information columns, 2 columns for policies and regulations, 4 columns for special topics, 3 columns for institutional functions, and 1 service column. The WeChat official account was launched from December 6, 2016 to December 31, 2021, with a total number of followers of more than 44,000.

In 2021, the WeChat official account had pushed information 121 times and released 208 pieces of information, and received 445,000 readings. Classified by the columns to which the information belonged, the quantity of information released in the main columns in 2021 is set forth as below:

VI. Increase the Efficiency to Handle with Complaints

(I) On-line consultation

In 2021, a total of 641 online consultation questions were received, in which, 634 were effective, with an decrease of 3.2% compared with that of 2020; There were 7 invalid consultations, and the main reason was that the problem was incompletely or unclearly described. In the effective consultations, 495 were replied, with a response rate of 78% and a 6% increase compared with that of 2020. Among the replied questions, 44 common questions (or problems with high attention) related to drug production and the business of CFDI had been published on the website, 451 general questions had been replied by email or SMS, and other questions had been further communicated with consultants and relied by telephone.

(II) On-line complaints and handling

In 2021, a total of 13 complaints were received, with a decrease of 50% compared with that of 2020. Among these complaints, 11 complaints were out of the functional scope of CFDI and had been transferred to the Center for Administrative Services and Complaints&Reporting of NMPA for handling; 1 was for consultation from the Complaints and Visits Office of the Department of Comprehensive Affairs; and 1 was related to inspection items of CFDI, which had been transferred to the Business Department of CFDI for handling. The handling rate of complaints and reporting was 100%.

(III) Online appointment

In 2021, a total of 105 online appointments were received. CFDI timely processed the received information and distributed the appointment information to all offices to complete on-site communication.

(IV) On-line investigation

The online questionnaire survey column on the website of CFDI is used to collect public opinions and suggestions on the website to improve the service quality of information disclosure and other work of the website. As of December 31, 2021, CFDI had received 25 valid questionnaire feedbacks, which had been transferred to relevant departments of CFDI and handled according to the Procedures for Management of Satisfaction Survey .

Ⅶ . Main Problems and Improvement Measures

In 2021, CFDI continued to promote the disclosure of drug inspection information and achieved good results in improving the online service platform and disclosing key information of drug inspection. However, CFDI still fails to fully meet the requirements of the NMPA and the needs of the public, which requires further efforts to enhance the information disclosure in key areas and improve the efficiency and quality of response to the public.

In 2022, according to the Regulations of the People's Republic of China on the Disclosure of Government Information and relevant requirements of the NMPA, CFDI will focus on the following work:

(I) Continue to strengthen the construction of the information disclosure platform. According to the needs of onsite inspection, CFDI will continue to improve the construction of the information disclosure system and the online service platform, and further enhance the convenience and security of the online service platform.

(II) Continue to promote information disclosure. CFDI, based on its functions, will further strengthen the publicity and interpretation of inspection policies and actively disclose information in key areas in accordance with the Procedures for Drug Registration Inspection (Trial) , Key Points and Determination Principles of Drug Registration Inspection (Pharmacology and Toxicology Study) (Trial) , Key Points and Determination Principles of Drug Registration Inspection (Drug Clinical Trials) (Trial) , Key Points and Determination Principles of Drug Registration Inspection (Pharmaceutical Research and Development (R&D) and Production Site) (Trial) , Work Procedures for Connection of Production On-site Inspection of Drug Registration and Pre-marketing Examination of Good Manufacturing Practice (GMP) (Trial) and related laws and regulations.

(III) Improve information disclosure management. CFDI shall strengthen the management of the content of information released, strictly implement the procedures for information disclosure, and improve the service level of information disclosure.

Center for Food and Drug Inspection of NMPA

January 5, 2022