On December 28th, the CFDA issued the “Opinions on Encouraging Drug Innovation to Implement Priority Review and Approval” (hereinafter referred to as “Opinions”). The “Opinions” clarified three types of drugs that can be included in the scope of priority review and approval.

The first category is a drug registration application that meets seven specific situations and has significant clinical value;

1. Application for registration of innovative drugs that are not marketed in China or abroad.

2. Transfer to an application for registration of innovative drugs produced in China.

3. Application for registration of drugs using advanced formulation techniques, innovative treatments, and significant therapeutic advantages.

4. The application for the clinical trial of the drug for 3 years before the expiration of the patent and the application for the production of the drug one year before the expiration of the patent.

5. Applicants apply for new drug clinical trials that are simultaneously applied for and approved for drug clinical trials in the United States and the European Union; applications for drug registrations that are produced in the same production line in China and are simultaneously applied for listing in the United States and EU drug approval agencies and have passed their on-site inspections.

6. Application for registration of Chinese medicine (including ethnic medicines) with clear clinical positioning in the prevention and treatment of major diseases.

7. Application for registration of new drugs listed in the National Science and Technology Major Project or the National Key R&D Program. First, the application for registration of new drugs that has been clinically tested by the National Center for Clinical Medical Research and approved by the central management department and has significant clinical value is included in the scope of priority review and approval.

The second category is for the registration of drugs with obvious clinical advantages for the seven diseases of AIDS, tuberculosis, viral hepatitis, rare diseases, malignant tumors, children's drugs, and the unique and multiple diseases of the elderly;

The third category is for four other cases of drug registration applications, namely:

1. In the conformity assessment of generic drugs, it is necessary to change the supplementary application for re-declaration of the approved process;

2. The self-inspection and verification project included in the “Announcement on Conducting Self-inspection and Verification of Drug Clinical Trial Data”, the applicant voluntarily withdraws and re-apply the application for registration of generic drugs after refining according to the standards consistent with the quality and efficacy of the original drug;

3. Drug application for clinically urgent and market shortage. The list of specific varieties was proposed by the National Health and Family Planning Commission and the Ministry of Industry and Information Technology. The Drug Evaluation Center of the Food and Drug Administration will organize the relevant departments and experts to determine it.

4. In the case of a major threat to public health, the application for registration of a drug that has obtained a compulsory license will be given priority for review and approval. The situation in which public health is seriously threatened and the procedures for initiating compulsory licensing are prescribed by the National Health and Family Planning Commission and relevant departments.

The "Opinions" were implemented from the date of promulgation, and the CFDA issued the "Opinions of the Food and Drug Administration on the implementation of the priority review and approval of the backlog of drug registration applications" issued by the CFDA on February 26, 2016 (Food and Drug Administration and Chemical Management [2016] ] No. 19) will be abolished.

Opinions on encouraging priority review and approval for drug innovation

Food and Drug Administration of the provinces, autonomous regions and municipalities directly under the Central Government, and the Food and Drug Administration of Xinjiang Production and Construction Corps:

In order to strengthen drug registration management, speed up the research and development of clinically valuable new drugs and clinically urgently needed generic drugs, and resolve the contradiction of drug registration applications, the following opinions are proposed.

First, the scope of priority review and approval

(1) A drug registration application with obvious clinical value and meeting one of the following conditions:

1. Application for registration of innovative drugs that are not marketed in China or abroad.

2. Transfer to an application for registration of innovative drugs produced in China.

3. Application for registration of drugs using advanced formulation techniques, innovative treatments, and significant therapeutic advantages.

4. The application for the clinical trial of the drug for 3 years before the expiration of the patent and the application for the production of the drug one year before the expiration of the patent.

5. Applicants apply for new drug clinical trials that are simultaneously applied for and approved for drug clinical trials in the United States and the European Union; applications for drug registrations that are produced in the same production line in China and are simultaneously applied for listing in the United States and EU drug approval agencies and have passed their on-site inspections.

6. Application for registration of Chinese medicine (including ethnic medicines) with clear clinical positioning in the prevention and treatment of major diseases.

7. It is included in the national science and technology major project, the national key research and development plan, and the application for new drug registration by the National Clinical Medical Research Center for clinical trials and approval by the central management department.

(2) Application for registration of drugs that have the following clinical advantages and have obvious clinical advantages:

1. AIDS;

2. tuberculosis;

3. Viral hepatitis;

4. Rare disease

5. Malignant tumor

6. Children's medicines;

7. A unique and multiple disease in the elderly.

(3) Others

1. In the conformity assessment of generic drugs, it is necessary to change the supplementary application for re-declaration of the approved process;

2. In the self-inspection and verification project of the “Notice on Carrying out Self-examination and Verification of Drug Clinical Trial Data” (No. 117 of the State Food and Drug Administration announced in 2015), the applicant took the initiative to withdraw and changed the quality and efficacy of the original drug. A generic registration application for re-declaration after a consistent standard is completed;

3. Drug application for clinically urgent and market shortage. The list of specific varieties is proposed by the National Health and Family Planning Commission and the Ministry of Industry and Information Technology. The Drug Evaluation Center of the Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center) organizes relevant departments and experts to demonstrate.

4. In the case of a major threat to public health, the application for registration of a drug that has obtained a compulsory license will be given priority for review and approval. The situation in which public health is seriously threatened and the procedures for initiating compulsory licensing are prescribed by the National Health and Family Planning Commission and relevant departments.

Second, the process of priority review and approval

(1) Application. After the registration application is transferred to the drug examination center, the applicant submits the application for priority review and approval to the drug examination center through the “applicant window” (see Appendix 1 for the application form), indicating the variety information and the reasons for inclusion in the priority review and approval.

(2) Review. For the application for priority review and approval submitted by the applicant, the drug review center will organize an expert review and demonstration every month, and publicize the results and reasons of the review and the specific information of the varieties to be reviewed. If there is no objection within 5 days (referring to the working day, the same below), the review procedure shall be given priority; if the object of the publicity is objected, the written opinion shall be submitted to the drug trial center within 5 days and the reasons shall be explained (see Appendix 2 for the objection table). The drug examination center will make a decision and notify all relevant parties after the organization of the argument within 10 days.

For the application of generic drugs with urgent clinical needs and market shortage, from the date of publication of the variety, the application for priority review and approval of new application varieties with the same active ingredients and the same route of administration will no longer be accepted.

(3) Review. The drug examination center shall prioritize the resources for reviewing the drug registration application listed in the priority review and approval according to the time sequence of the registration application transferred to the drug testing center.

1. New drug clinical trial application.

Applicants may submit an application for communication with the drug testing center before submitting the clinical trial registration application, whether the existing research data fully supports the major clinical problems such as the phase I clinical trial, whether the risk of the clinical trial subjects is controllable. After receiving the application for communication, the drug examination center will form a review team and form a preliminary opinion. The communication will be arranged with the applicant within 30 days, and the communication result will be clearly agreed on the meeting minutes formed on the spot.

Under the premise of sufficient communication and declaration before the application, and the declaration data is standardized and complete, the drug examination center will start the technical review within 10 days from the date when the clinical trial registration application is confirmed to be included in the priority review and approval.

After the completion of Phase I and Phase II clinical trials, the applicant submits the trial results and the next clinical trial protocol in a timely manner. The drug review center arranges communication with the applicant within 30 days after receiving the information. If no safety problems are found, they can be transferred to the next clinical trial after communicating with the drug trial center. For the results of the trials showing no better than the trend of the listed drugs, no priority will be given.

For rare diseases or other special diseases, you can apply for reducing the number of clinical trial cases or exempting from clinical trials when applying for clinical trials. The drug review center makes a review opinion on whether to approve the application based on the technical review needs and the actual situation of the Chinese patient.

2. New drug production registration application.

Before submitting a new drug production registration application, the applicant should communicate with the drug testing center whether the existing research data supports the new drug production application. The drug review center will arrange a meeting to communicate with the applicant within 30 days after receiving the application. The drug review center initiates a technical review within 10 days from the date the drug registration application is included in the priority review and approval. If there is any objection to the application materials or needs to be supplemented, the applicant shall be notified at one time the items that need to be supplemented. The drug review center restarted the technical review within 5 days after receiving the supplementary information.

After the completion of the technical review, the drug examination center will notify the Food and Drug Administration of the Food and Drug Administration (hereinafter referred to as the verification center) and the applicant to conduct production site inspection. The on-site inspection shall be carried out within 20 days after the notice of the drug examination center is issued. The conclusion of the inspection shall be made within 10 days after the completion of the inspection and delivered to the drug examination center. Samples for on-site sampling inspection shall be delivered to the drug inspection agency within 5 days. The drug inspection agency shall give priority to the sample inspection and issue the inspection conclusion within a maximum of 90 days.

3. Generic drug registration application.

The drug review center initiates a technical review within 10 days from the date of the application for registration of generic drugs for inclusion in the priority review and approval. Where additional information is required from the applicant, the supplementary matters shall be notified at one time. The drug review center restarted the technical review within 5 days after receiving the supplementary information.

4. For the treatment of serious life-threatening diseases, there is no effective treatment, and new drugs that are of great significance for solving clinical needs. Applicants can apply for face-to-face communication with the drug testing center at any time after preparation. The reviewers should be within 10 days. Schedule meetings to exchange views. In the clinical trial phase, the drug trial center should maintain communication with the applicant to guide and promote the development of new drug clinical trials; if based on early clinical trial data, it can reasonably predict or judge its clinical benefit and is more obvious than existing treatment methods. The advantage allows for conditional approval of the market prior to completion of the Phase III confirmatory clinical trial.

(4) Submission. The drug examination center will complete the comprehensive evaluation report within 5 days after receiving the sample production site inspection report and sample inspection results, and submit it to the Food and Drug Administration for approval within 3 days. For cases where a re-review is found during the comprehensive review process, priority is given on a case-by-case basis.

(5) Approval. The Food and Drug Administration will make an approval decision within 10 days after receiving the review materials submitted by the drug review center.

Third, priority review and approval work requirements

(1) The drug examination center shall establish a meeting communication mechanism and an online consultation platform with the applicant for the application for registration of new drugs for priority review and approval. The reviewer does not communicate privately with the applicant. For the drug registration application for priority review and approval, the Food and Drug Administration will give priority to the verification of the authenticity of the drug clinical trial data.

(2) When the drug for priority review and approval is approved, the declaration of the raw materials and preparations shall be reported at the same time. If the receiving time of the two is not synchronized, the last receiving time shall prevail.

(3) Before submitting the application for priority review and approval, the applicant shall submit the materials in accordance with the relevant technical principles and prepare for the on-site inspection. If there is a large defect in the application materials, the clinical trial data is distorted, or the site inspection or sample inspection is not accepted on time, the decision not to approve is directly made; if there is any problem with the authenticity of the application materials, the applicant will not be accepted within 3 years. Other varieties of applications for priority review and approval.

(4) In the process of technical review, if the variety declaration materials that are included in the scope of priority review and approval cannot meet the conditions for priority review, the drug testing center will terminate the priority review of the variety and return to the normal review sequence to re-queue.

(5) For imported children's medicines that are clinically needed and listed in the United States, the European Union, and China's surrounding areas, relevant clinical trial data completed overseas may be used for drug registration applications in China.

(6) The food and drug supervision departments at all levels that undertake the acceptance and inspection and verification shall strengthen the acceptance examination, the on-site inspection and/or the production site inspection of the relevant drug registration application, and prevent the drug registration application without the review conditions from entering the trial. Comment section.

(7) The application for registration of drugs required for emergency treatment of public health emergencies shall be handled in accordance with the relevant regulations.

This opinion was implemented from the date of promulgation, and the Food and Drug Administration issued the “Opinions of the Food and Drug Administration on the Implementation of the Priority Review and Approval of the Backlog of Drug Registration Applications” issued by the General Administration of Food and Drug Administration in February 2016 (Food and Drug Administration and Chemical Management [2016]19 No.) At the same time abolished.

Food and Drug Administration

December 21, 2017

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