Article 1 in order to maintain the drugs and medical devices registration applicant's legitimate rights and interests, regulate and strengthen the review and approval of medicines and medical equipment information security management, according to the "People's Republic of China" Drug Administration Law "medical equipment supervision and management regulations" and other laws and regulations, to develop this approach.

Article second the State Food and Drug Administration (hereinafter referred to as the food and Drug Administration) departments and directly affiliated institutions engaged in pharmaceuticals, medical devices registration acceptance, technical review, on-site inspection, registration inspection, administrative examination and approval (hereinafter referred to as the review and approval) staff (including staff) and participate in the review and approval of experts, confidentiality the obligation of information related to that review and approval in the work.

Medicines, medical devices and related personnel to participate in the review and approval of the expert review and approval for breach of confidentiality obligations suspected of a crime, transferred to judicial organs according to law; if no crime is constituted, in accordance with the relevant provisions and the way to deal with.

Article third examination and approval information belongs to state secrets, in accordance with the law of the People's Republic of China on the secrets of state secrets and other laws and regulations and the State Administration of food and Drug Administration confidential work implementation.

The following information in the fourth review and examination and approval process belongs to the confidential information provided for in these measures:

(I) the information submitted by the applicant during the review and approval phase and the review of the production process, key technical parameters, technical know-how, test data and other information relating to individual privacy after the examination and approval;

(two) not permitted to disclose the information including review and approval, review and approval procedures have not been issued, according to the conclusion according to the evaluation procedure has not yet announced the approval process of the discussions, advice and technical reports;

(three) review and approval of complaints and other information during the examination and approval.

In the light of the actual work of the pharmaceutical and medical apparatus review organs, the food and drug administration shall make clear the detailed list of confidential information and report it to the general office for approval.

Fifth the following information does not belong to the confidential information provided for in these measures:

(1) in the technical data submitted by the applicant, it belongs to the patent matters or the national drug standards of the Chinese Pharmacopoeia, the national standards and trade standards of medical equipment;

(two) industry known information;

(three) the information that should be disclosed in accordance with the requirements of the government information disclosure;

(four) approval of public information in accordance with statutory procedures.

The sixth staff engaged in the examination and approval and the experts involved in the examination and approval shall strictly abide by the confidentiality provisions and shall not be subjected to the following acts:

(1) the confidential information carrier shall be taken out of the prescribed work place without authorization or used outside the designated network or equipment;

(two) unauthorized copy, photography, copy, paper documents and electronic records relevant information;

(three) the paper documents and electronic information to the variety registration acceptance, technical review, on-site inspection, registration inspection, administrative approval and other persons not unrelated to the regulatory staff to read or use, or to disclose relevant information to the variety registration acceptance, technical review, on-site inspection, inspection, registration the administrative examination and approval and other persons not unrelated to the varieties of supervision personnel;

(four) alter, forge, replace, destroy, discard or destroy confidential information without authorization;

(five) using relevant information or information to engage in activities unrelated to duties.

Seventh experts engaged in the examination and approval and the experts involved in the review and approval have not been approved in accordance with the statutory procedures. If any of the following circumstances occurs, they shall be deemed to have leaked confidential information:

(1) disclosing the applicant's technical data or other business secrets;

(two) use the applicant's technical materials or other trade secrets for non work purposes;

(three) allowing others to use the applicant's technical materials or other business secrets;

(four) disclosure of examination and approval information.

Eighth of the food and drug administration organs of various departments and institutions directly under the charge of the daily management of confidential information, in conjunction with the office of the relevant units to carry out the investigation and handling of cases of the disclosure of confidential information.

The general office of the food and drug administration is responsible for urging relevant units to strengthen confidential education, implement the secrecy system, enforce confidentiality regulations, and organize secret service staff to conduct confidential knowledge tests each year. Those who fail to keep confidential knowledge shall be required to participate in the training according to the regulations; those who are still unqualified after the training shall be transferred from the relevant posts.

The food and drug administration to review and approval of the departments and institutions directly under the unit staff responsible for security education, formulating security system and regular inspection, found the leak timely report to the office and put forward opinions.

Ninth of the food and drug administration to review and approval of departments and directly affiliated institutions shall take effective measures to strengthen the confidentiality of information carrier management, clear access to and use of the program. The use of confidential information shall be in the written consent of the person in charge of the entity, and shall record the use time, purpose and personnel.

The examination and approval electronic information system shall have corresponding safety prevention and control measures, meet the requirements of the national information system security level protection standards, and prevent the leakage of electronic information. The management departments and personnel of the electronic information system shall adopt safety technical means to ensure the safety of information system login and use.

Electronic information system management departments and personnel departments, and personnel shall use the information system related technical documents, charts, procedures, and the corresponding data on the device identifier and password, data confidentiality obligation. The personnel of the electronic information system shall take proper measures to keep personal account information and login passwords so as to prevent unauthorized access.

No department or personnel may alter or disclose the system configuration parameters related to the management and operation of the information system and the various information carried by the equipment used. Do not turn off the tracking system when using electronic information systems.

Has nothing to do with the review and approval of personnel, shall not contact the review and approval of confidential information; due to work needs access to the confidential information, shall be according to the procedure after the information storage unit is responsible for people and confidential written consent records, operation time, purpose, and confidentiality obligations in accordance with the provisions of relevant laws and regulations and these measures.

Tenth of the food and drug administration to review and approval departments and institutions directly under the staff entry, shall be subject to the confidentiality of education, and signed a confidentiality agreement with the unit, shall bear the liability of confidentiality. When the relevant staff members leave the former job, they shall bear the confidentiality responsibility for the relevant information in accordance with the relevant regulations.

Responsible for the confidentiality agreement signed with the relevant staff from the unit, the departments and institutions directly under the main person responsible for the confidentiality agreement by the food and Drug Administration of the responsible person in charge of departments and directly affiliated institutions, mainly responsible for the signing of the food and drug administration, responsible person in charge of the confidentiality agreement by the food and Drug Administration and the main person in charge of the responsible person in charge of signing.

A confidentiality agreement signed by workers kept by the food and drug administration departments and institutions directly under the comprehensive department, the confidentiality agreement signed by the departmental cadres Office of food and drug administration.

Experts participating in the review and approval, should be related to the food and drug administration departments or institutions directly under signed confidentiality agreements to keep confidential. The expert confidentiality agreement by the food and Drug Administration of the relevant departments or units directly under custody.

The food and drug administration style prescribed by the general office of the confidentiality agreement, the relevant departments and institutions directly under the unit with the actual formulation of a specific text confidentiality agreement.

Eleventh there is evidence in the review and approval of staff in violation of the present measures, according to the circumstances, to give criticism and education, from job processing or warnings, demerits, demerits, demotion, dismissal, dismissal of lower level jobs, such as punishment:

(a) with the first sixth or second, if the circumstances are minor, give criticism and education; if the circumstances are serious, give out of work or warning, demerit; incorrigible, given a demerit or demerits;

(two) the sixth means third, fourth or fifth, yet the consequences, given a demerit or demerits; consequences, demotion, lower level jobs, dismissal or dismissal;

(three) in violation of the relevant provisions of the unauthorized use of the confidential information carrier or electronic information system, or close tracking system, to reduce post grades or demerits punishment; consequences, be punished by dismissal;

(four) the seventh way to the first and second or third acts, intentional disclosure of confidential information, suspected to constitute the crime of infringement of business secret, transferred to judicial organs for criminal responsibility according to law, and be punished by dismissal;

(five) the seventh approach fourth acts, intentional disclosure of confidential information, suspected to constitute the crime of breach of privilege, dereliction of duty or disclosure of state secrets, transferred to judicial organs for criminal responsibility according to law, and be punished by dismissal.

In the review and approval of staff by major demerit, demotion, reduce post grades or dismissal administrative punishment, should be removed from the workplace. The staff members who have been transferred from their posts may be engaged in the original examination and approval before they have passed the training and assessment.

Twelfth of the food and drug administration to review and approval of departments and institutions directly under the confidential information leakage events, to be criticized for the unit, and according to the law officers, directly responsible for the other directly responsible personnel and confidential responsible person shall be given administrative sanctions.

Intentionally concealing the leak or leaks found no treatment, according to the person in charge directly responsible and other directly responsible personnel and confidential responsible person given demerits, demotion, dismissal or dismissal.

Thirteenth of the food and drug administration to review and approval of departments and institutions directly under the confidential information leakage events, causing serious consequences, the direct responsibility for the relevant unit management responsibilities according to law.

Fourteenth experts involved in the review and approval, in violation of the provisions of these measures, disclose confidential information, suspected of committing crimes, transferred to judicial organs, according to law for criminal responsibility.

Relevant experts disclosure of confidential information, causing losses to the applicant or the supervisory and administrative department of food and drugs, the applicant or the food and drug administration departments may bring a lawsuit to the people's court, claim for compensation according to law.

Article fifteenth if the applicant has evidence to prove that the relevant units or personnel or the relevant experts disclose confidential information and cause losses to them, they shall have the right to file a lawsuit with the people's court.

The people's court for food and drug administration departments in accordance with the law of compensation, food and drug supervision and management departments for compensation for damages, shall order the disclosure of confidential information staff and experts take part or all of the damages.

Sixteenth, involving the review and approval staff to disclose confidential information complaints and reports, as well as confidential information disclosure case investigation, the food and Drug Administration General Office in conjunction with the relevant units in accordance with procedures. After the conclusion of the investigation, it is suggested that the handling opinions be deemed to be transferred to the judicial organs, and the transfer proposals shall be submitted to the General Administration of food and Drug Administration for approval.

Seventeenth provide information storage, maintenance, transfer, processing units and personnel services and other contact information review and approval units and personnel for review and approval, to know their work should be confidential information, undertake confidentiality obligations in accordance with the relevant provisions of laws and regulations and these measures; the disclosure of confidential information, in accordance with the regulations.

The confidential information management of the eighteenth provinces, autonomous regions and municipalities directly under the central government and the food and drug administration during the examination and approval process shall be implemented in accordance with these measures.

Article nineteenth of these measures from the date of promulgation of the implementation.