Medical network on December 30 - to maintain the legitimate rights and interests of the applicant for drugs, medical devices registration, the specification and in order to strengthen the management of drugs, medical apparatus and instruments for examination and approval of the review is confidential, the food and drug supervision bureau drafted the administration of state food and drug supervision and administration of pharmaceuticals medical apparatus and instruments for examination and approval of the review is confidential management regulations (draft) ", now solicit opinions from all walks of life. The relevant units and the social people from all walks of life can be on January 12, 2017, to present an opinion by the following way:
1. Through the mail send to the opinions of the Beijing xicheng district xuanwu gate west street, tower 2, 26 yuan (zip code 100053) the food and drug supervision administration of the legal system, and on the envelope marked "drug" measures for the management of medical apparatus and instruments for examination and approval of the review is confidential opinion.
2. By fax to: your opinion 010-88330705.
3. Will advice by E-mail to xuxy@cfda.gov.cn, and let us know the email subject "drug" measures for the management of medical apparatus and instruments for examination and approval of the review is confidential opinion.
The food and drug supervision bureau
On December 29, 2016
State food and drug supervision and administration bureau
Drug measures for the management of medical apparatus and instruments for examination and approval of the review is confidential
(draft)
First [legislative purpose] to safeguard the legitimate rights and interests of the applicant for drugs, medical devices registration, specifications, and in order to strengthen the management of drugs, medical apparatus and instruments for examination and approval of the review is confidential, in accordance with the "drug administration law regulations on the supervision and administration of medical devices and other laws and regulations and these measures.
Article 2 the state food and drug supervision and administration of confidentiality obligations administration (hereinafter referred to as the food and drug supervision bureau) organs and directly affiliated institutions engaged in pharmaceutical, medical device registration acceptance, technical review, on-site inspection, registration, inspection, administrative examination and approval (hereinafter referred to as the review of the examination and approval) of staff (including contract workers) and participate in the review of the examination and approval, aware of the relevant information in the review of the examination and approval work bear confidentiality obligations.
Medicines, medical apparatus and instruments for examination and approval of the review the experts in related staff and participate in the review of the examination and approval of alleged breach of confidentiality obligations, in accordance with the law, move send a judiciary processing. Does not yet constitute a crime, and the way to deal with according to relevant regulations.
Article 3 the scope of confidentiality review the following information in confidential management in the process of examination and approval:
(a) the applicant to submit the production process, the key technical parameters, technical know-how, the test data and other information;
(2) is not allowed to disclosed information for examination and approval of the review, including the program has not yet issued for examination and approval of the review conclusion, according to the program has not yet been released by the discussion in the review process of examination and approval opinions, advice and technical reports, etc.;
(3) review complaints to report information such as the examination and approval process.
The above information pertaining to state secrets, according to the law on guarding state secrets and other laws and regulations and the measures for the administration of the food and drug supervision administration confidential executed.
Food and drug supervision administration of drugs and medical appliance review agencies combined with working practice, specific list of confidential information, submitted to the general office of consent.
Article 4 the "non confidential matters" information does not belong to the confidential information of the following:
(a) the applicant belongs to patent matters or submit the technical data of China pharmacopoeia and other national drug standards, medical equipment in the national standard and industry standard public matters;
(2) of the known information of the industry;
(3) according to the requirements of the government information disclosure shall be public information;
(4) approval of public information in accordance with legal procedure.
Article 5 [prohibitive provisions] is engaged in the review of the examination and approval of staff and participate in the review of the examination and approval of experts shall strictly abide by the confidentiality provisions and shall not in any of the following actions:
(a) the confidential information carrier to take away from the workplace or unauthorized outside the specified network, equipment use.
(2) copy, filming, transcribing, recording relevant paper and electronic data information;
(3) the paper materials, electronic information to the registration acceptance with the varieties, technology review, on-site inspection, registration, inspection, independent of administrative examination and approval and the other has nothing to do with the variety regulation of the personnel to read or use, or disclose the related information to the variety registration acceptance, technical review, on-site inspection, registration, inspection, independent of administrative examination and approval and the other has nothing to do with the variety regulation of the personnel;
(4) altered, forged, replacement, damaged, discarded or destruction of confidential information without authorization;
(5) using the relevant data or information engaged in the activities of has nothing to do with the job responsibilities.
Article 6 in leak case review approval to staff and participate in the review without approval according to legal procedure for examination and approval of experts, in any of the following circumstances, as a leaked confidential information:
(a) disclosure of the applicant technical data or other business secret;
(2) use the technical data or other business secret for non-work purposes;
(3) to allow others to use the technical data or other business secret;
(4) information disclosure review for examination and approval.
Article 7 [responsibilities] the food and drug supervision administration departments, directly affiliated institutions responsible for the daily management of confidential information, the general office of the party committee discipline inspection commission jointly with the personnel department, departments to carry out leakage cases of the investigation and handling of confidential information.
The food and drug supervision administration office is responsible for urged relevant units to strengthen security education, to carry out the secrecy, perform security regulations; Annual classified post staff confidential knowledge test, confidential knowledge test results in the staff personal file. Confidential knowledge test unqualified shall, in accordance with the provisions to attend training; After training evaluation is still not qualified, transferring the relevant jobs.
The food and drug supervision administration involves the evaluation of examination and approval departments, directly affiliated institutions in charge of this unit staff secrecy education, formulating security system and regular inspection, found that the leaks timely report to general office, the personnel department and organs party commission for discipline inspection and treatment Suggestions are put forward.
Article 8 the secret carrier and information system management food and drug supervision administration involved in the review of examination and approval departments, directly affiliated institutions shall take effective measures to strengthen the management of confidential information carrier, clear the access to and use of the program. Use contains confidential information of the file, shall be approved by this unit, head of the secret written and recorded using the information such as time, purpose and use of personnel.
Review for examination and approval of the electronic information system should have the corresponding safety control measures, accord with the requirement of national information system security protection standard, to prevent leakage of electronic information. Electronic information system management departments and personnel safety technical measures shall be taken to ensure the security of information system login and use.
Electronic information system management departments and personnel departments, the use of personnel and shall be the technical documentation relating to the information system, charts, programs, data, and the corresponding device password, identifier, and bear the obligation to keep confidential data, etc. Electronic information system using personnel shall take proper measures to keep personal account information and password, to prevent unauthorized access.
Any department or personnel shall not, without change, reveal related to information system management and operation of the system configuration parameters, equipment used, carrying all kinds of information. When using the electronic information system, can not close the tracking system.
Has nothing to do with the review of the examination and approval, shall not contact the review for examination and approval of the confidential information; Because of work need to truly access to confidential information and shall keep the head unit and programmed by the information secrecy, written consent, head and record users, using time and purpose.
Article 9 the food and drug supervision administration involves confidential management protocol review for examination and approval departments and directly affiliated institutions staff induction, ought to sign confidentiality agreement with place unit, responsible for confidentiality. Relevant staff from the original work, shall, in accordance with the relevant provisions of related information confidential responsibility, confidentiality period shall not be less than three years.
Confidentiality agreement signed by unit leaders and the related staff, departments and directly affiliated institutions, confidentiality agreement by the food and drug supervision bureau in charge of the head and departments, directly affiliated institutions signed, head of the main food and drug supervision bureau, director in charge of the confidentiality agreement with the charge by the food and drug supervision administration principal sign.
Staff confidentiality agreement signed by the food and drug supervision administration departments, directly affiliated institutions comprehensive department or personnel management department, the department bureau class cadre confidentiality agreement signed by the general office of the food and drug supervision bureau, the personnel department.
To participate in the review experts for examination and approval, shall be related to the food and drug supervision bureau directly under the departments or institutions signed a confidentiality agreement, responsible for confidentiality. Experts confidentiality agreement by the food and drug supervision administration of the relevant departments or institutions directly under custody.
The food and drug supervision administration style of confidentiality agreement shall be formulated by the general office, related departments and directly affiliated institutions are formulated based on the actual unit specific text of confidentiality agreement.
Article 10 the relevant personnel responsibility there is evidence that is engaged in the review of the examination and approval of personnel in violation of the provisions of these measures, according to the seriousness, giving critical education from their jobs, such as processing or give warning, demerit recording and etc, demoted, sacked, fire and other administrative sanctions:
(a) the first or the second act, article 5 of the measures, if the circumstances are minor, giving critical education; If the circumstances are relatively serious, give out jobs processing or warning, demerit punishment; To change, to give a demerit or give disciplinary action.
(2) of paragraph 3, article 5 of these measures, the fourth or fifth behavior, the consequences have not yet resulted in, give, give a demerit or sanction. Consequences resulting from the breach, a downgrade, dismissed or expelled;
(3) in violation of relevant provisions, unauthorized use of confidential information carrier or electronic information systems, or close the tracking system, give give punishment; Cause consequences, give expelled;
(4) in the first paragraph in article 6 hereof, the second or the third act, deliberately leaked confidential information, suspected case constitutes the crime of infringing business secret, handed over to the judicial organs shall be investigated for criminal responsibility according to law, and to give expelled;
(5) in item 4 of article 6 hereof, deliberately leaked confidential information, alleged constitute the crime of abuse of power and dereliction of duty or the crime of divulging state secrets, handed over to the judicial organs shall be investigated for criminal responsibility according to law, and to give expelled.
Evidence of leak confidential information referred to in the preceding paragraph include can prove relevant personnel in violation of the provisions of these measures, electronic documentary evidence, material evidence and audio-visual data, the testimony of witnesses and other evidence.
Article 11 the relevant unit responsibility food and drug supervision administration involves the evaluation of examination and approval departments, directly affiliated institutions of leaked confidential information events, the unit shall be criticized, and in accordance with law, the person in charge directly responsible and other persons directly responsible and confidential director shall be given administrative sanctions.
Deliberately hiding leaks or find leaks will not be processed, in accordance with law, the person in charge directly responsible and other persons directly responsible and confidential director give to give, demoted, dismissed or expelled.
Article 12 the food and drug supervision bureau leadership responsibility involves the evaluation of examination and approval departments, directly affiliated institutions leaked confidential information events, thereby causing serious consequences, shall be investigated for party place unit directly responsible management responsibility and the leadership of the head at the next higher level of responsibility.
Article 13 to participate in the review to the approval of expert responsibility expert in violation of the provisions of these measures, disclose confidential information, suspected of a crime, handed over to the judicial organs shall be investigated for criminal responsibility according to law.
Experts reveal confidential information, losses to the applicant or the food and drug supervision and administration department, the applicant or the food and drug supervision and administration department may bring a suit before a people's court, in accordance with the request for compensation.
Article 14 the liability to pay compensation there is evidence that the relevant units or personnel, concerned expert losses to the confidential information and shall have the right to bring a suit before a people's court.
Ruling the food and drug supervision and administration department of the people's court in accordance with the law shall be compensation, compensation for losses, the food and drug supervision and regulation department shall be ordered to leak confidential information of the staff, experts, to bear part or all of the damages.
Article 15 accountability procedures involving the review approval workers complain inform against leak confidential information, as well as the leaked confidential information of the case investigation, by the general office of the food and drug supervision bureau party committee discipline inspection commission jointly with the personnel department, departments in accordance with the procedure. End processing opinions after investigation, think that should be transferred to judicial organs, transfer Suggestions, according to the application submitted to the food and drug supervision administration decision.
Article 16 for the third party confidentiality management review approval information storage, maintenance, transfer, sorting and other services units and personnel, and other units and personnel may contact information for examination and approval of the review, they have come to know in the work of the confidential information, in accordance with relevant provisions of the relevant laws, regulations and these measures bear confidentiality obligations; Leakage of confidential information, in accordance with the provisions of this way to deal with.
Article 17 provinces, autonomous regions and municipalities directly under the central government ShengJu refer to perform food and drug supervision and administration department for examination and approval of the review these measures shall also, mutatis mutandis, apply to the confidential information in the process of management.
Article 18 the implementation date since the date of publishing the implementation of the measures. |
