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| As of 9.24, the overseas inspection regulations of drugs are required to solicit opinions |
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| Author：中國(guó)銘鉉 企劃部 Release Time：2017-9-1 10:46:26 Number Browse：794 |
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Medical website September 1, August 31, "drug foreign inspection regulations (draft)" to solicit opinions, the time as of September 24, 2017.
Regulations on overseas inspection and administration of pharmaceuticals
(draft)
Chapter I general provisions
Article 1 the provisions of this regulation shall be formulated in accordance with relevant laws and regulations and technical specifications, such as the drug administration law of the People's Republic of China, in order to standardize the overseas inspection work of pharmaceuticals.
Article 2 [applicable scope] this provision applies to the inspection of overseas development and production of drugs already listed in China or that are intended to be listed in China.
Article 3 the term definition 】 【 overseas examination refers to the state food and drug supervision and administration of drug administration (hereinafter referred to as the bureau) to confirm the reliability and reality of drugs outside the development, production and compliance, inspection on the implementation of abroad.
Article 4 the administration of [responsibilities] is responsible for the drug inspection management, administration of the food and drug audit inspection center (hereinafter referred to as the inspection center) is responsible for organizing the implementation of pharmaceutical inspection work overseas.
China's general administration of the food and drug verification research institute, administration of drug approval center, drug evaluation center (hereinafter referred to as "courtyard in the check respectively, human medicinal center, evaluation center) and other directly affiliated institutions according to their respective functions help to carry out the inspection work.The above units shall be responsible for the guidance and inspection of foreign drug sampling in addition to the overseas inspection tasks as prescribed by the regulations;The pharmaceutical audit center is responsible for the subsequent processing of the variety of the approval stage of the registration review.The evaluation center is responsible for the evaluation of overseas inspection varieties.
Article 5 [information disclosure] the general administration shall make public inspection of the basic conditions and the results of the inspection in accordance with the requirements of the government information.
Article 6 [disciplinary requirements] shall strictly abide by the requirements of the laws, regulations, integrity, secrecy and discipline of foreign affairs.
Chapter ii determination of inspection tasks
Article 7 the units directly under administration and related inspection scheme according to their respective functions to check varieties and the import of the manufacturer, through the risk assessment and the way of random sampling, annual inspection plan and the basic information of the public inspection plan.
If necessary, the materials, auxiliary materials, packaging materials and other links to carry out the extension inspection.
Article 8 】 【 risk assessment of risk assessment mainly consider the drug registration review, daily supervision, examination and approval of import inspection, risk of adverse drug reactions monitoring and complaints to report information, to determine the annual inspection plan.Focus on the following factors:
(1) when applying for drug registration or supplementary application, the review work shall be carried out;
(2) if the import inspection or supervision of the spot inspection is not qualified;
(3) drug adverse reaction monitoring, complaint reporting or other clues may have a quality safety risk;
(4) the importer has a bad record;
(5) the import manufacturers accept the on-site inspection by the foreign drug regulatory agencies to show that there are major problems in the relevant production plants;
(6) re-examination after rectification;
(7) other circumstances requiring the overseas inspection of drugs.
Article 9 the verification center shall send the import manufacturer (annex 1) to the notice of overseas inspection of pharmaceuticals (annex 1).Import vendors in 20 working days upon receipt of the drugs overseas check told verification center submitted outside the pharmaceutical inspection basic situation table "(attachment 2), 40 working days according to the plant master file list (attachment 3) submit factory owners documents and other materials needed to check.
The verification center may, in accordance with the inspection requirements, be able to collect relevant technical data related to the inspection of the variety of the species in other direct units of the general administration, and the relevant units shall support and cooperate with them.The technical data to be transferred shall take necessary confidentiality measures, and the management shall be filed after inspection.
Article 10 after the verification center receives the basic situation table of the inspection of the drug abroad, it shall draw up the initial inspection time and notify the importer according to the general arrangement of the inspection work.Import manufacturers put forward delay check, shall receive inspection time, within 10 working days after notification of the verification center put forward written application and explain the reasons, accordance with the inspection by the verification center after comprehensive consideration, determine the final inspection time.
Article 11 the inspection section shall be composed of two or more inspectors, and the inspection team shall exercise the team leader.The inspectors shall be persons who have obtained the qualification of the inspectors according to law or those who obtained the authorization of the inspection;According to the need of inspection, relevant field experts can be asked to take part in the inspection.
The inspectors shall sign a statement of non-interest conflict and a clean government undertaking;Where any conflict or conflict may arise between the inspection activities and the personal interests of the person engaged, the avoidance shall be offered voluntarily.
Article 12 the "communication" import vendors shall be responsible for and related units under inspection (including overseas factories, research and development institutions, raw materials and packaging materials factory, the third party inspection institutions, etc.) communication and coordination check related matters.
Article 13 the import manufacturers shall coordinate and cooperate with overseas inspection to ensure the smooth development of the inspection, and shall not delay, obstruct, evade or refuse inspection.
Article 14 drugs outside the working language 】 【 check working language is Chinese, import vendor submit the declaration, the rectification report and other materials shall be the Chinese version, during the inspection should be equipped with can meet the need of the translator, because import vendors for any language translation cause responsible for the mistake.
Chapter iii inspection
Article 15 the verification center shall be responsible for the formulation of overseas inspection plans for drugs, and inspection teams shall conduct on-site inspections according to the inspection plan.When a change inspection plan is required, the inspection team shall report the approval of the verification center to implement it.
Article 16 "first meeting" at the start of the inspection, inspection teams should be hosting a meeting for the first time to import the manufacturer notified of inspectors, objectives and scope of inspection, inspection schedule and claim check points for attention and discipline inspection, etc.
The import manufacturer shall introduce to the inspection team the registration, production and quality control of the inspected drug, and make a clear inspection of the head of the site.
Article 17 [coordination inspection] during inspection, the importer shall open the relevant premises and areas to the inspection unit, cooperate with the inspection of the relevant facilities and equipment, and maintain the normal production status;According to the inspection schedule, arrange the dynamic production of the key production process of the inspected varieties;Timely provide the documents, records and electronic data needed for the inspection, and answer the inspection questions truthfully.
Article 18 [evidentiary materials] the inspection group may take photocopying, photographing, photographing and other methods to collect evidences according to the needs of inspection.
Article 19 the inspection unit shall, according to the sampling procedure, sample and seal the sample during the inspection.
Samples shall be returned to the territory by inspection team or sent by the importer to carry out inspection.The importer shall ensure that the packing and shipping conditions of the samples meet the requirements and the sample quality is not affected.
Article 20 [immediate report] the inspection team shall report to the verification centre immediately and make preliminary recommendations on the disposition of serious quality risks.
Article 21. Prior to the conclusion of the inspection, the inspection unit shall preside over the final meeting, report the inspection to the importer and inspect the problems, and make a good record.
If there is any objection, the importer may state the claim, and the inspection team shall further verify the relevant information and make a good record.
Article 22 [inspection report] the inspection unit shall complete the inspection report within the time limit after the examination and completion and sign and confirm by all the inspectors.
Chapter iv examination and disposal
Article 23 the inspection center shall, within 40 working days from the date of the inspection and the completion of the inspection, give a written feedback to the importer of the defect form of the drug inspection abroad (annex 4).
The inspection agency shall complete the inspection within the statutory time limit upon receipt of the sample, and the inspection time shall not be included in the time limit of the feedback.
Article 24 the rectification of the import vendor shall receive 】 outside the pharmaceutical inspection defects table of 30 working days from the date of submit to the inspection center, the improvement plan of the inspection found that the problem can't complete the rectification within the prescribed time limit individual defects, shall submit a detailed schedule and the rectification of the follow-up plan, and submit the corresponding updates until corrective implement completely.
Article 25 the verification center should be combined with comprehensive evaluation 】 【 import vendors rectification of comprehensive evaluation of site inspection report, comprehensive assessment should be completed within 40 working days after receiving the rectification report.If necessary, the rectification can be reviewed.The review time is not included in the comprehensive evaluation time limit.
Article 26 [decision principle] the comprehensive assessment shall adopt the principles of risk assessment, comprehensively consider the nature of the defect, severity and the category of the products to be evaluated.
The comprehensive evaluation conclusion is divided into "meet the requirements" and "meet the requirements" and "not meet the requirements".The ruling principles are as follows:
(1) the site inspection shall be deemed to be "in conformity with the requirements" if the defects are not found or are found only in general.
(2) the main defects are found in the on-site inspection, but the rectification report submitted shows that the product can be produced according to the requirements of GMP after the rectification, which is deemed to be "after the rectification".
(3) the on-site inspection found authenticity, the key elements affecting the quality of products and registration information is not consistent, there are serious defects and major defects and corrective actions, corrective plan is not feasible and does not comply with the laws and regulations and the requirements of the technical specification, judged to be "does not conform to the requirements.
Article 27 [uncooperative situations] if one of the following circumstances occurs, it shall be deemed that the importer has delayed, obstructed, avoided or refused to inspect, and the conclusion has been directly judged to be "non-compliance" :
(1) after receiving the notification of the overseas inspection of the drug, failing to reply or refusing to provide relevant documents and materials within the prescribed time limit;
(2) being inspected by the import manufacturer for two times;
(3) to be inspected for the refusal of the import manufacturers to arrange the dynamic production;
(4) failing to cooperate with overseas inspection procedures;
(5) failing to cooperate with the extension inspection;
(6) delay, obstruct, restrict or refuse to enter into the site or area of the inspected site or limit the inspection time;
(7) delay, refuse to provide or deliberately conceal the key inspection information;
(8) refusing or restricting on-site inspection and forensics;
(9) other circumstances not cooperating with the inspection.
Article 28 to check audit opinion 】 【 conclusion is "qualified", "meets the requirements after rectification" and "do not conform to the requirements, inspection center should make a comprehensive evaluation of 40 working days from the date of formation of drugs outside inspection audit opinion, submitted to the administration and inspection unit is put forward.
The site report of the inspection unit or the comprehensive assessment shall find that there are major quality problems and urgent measures should be taken to the general administration of the state.
Classify the article 29 【 】 varieties of register for examination and approval of the review stage, administration combined with the comprehensive evaluation conclusion, on the basis of the pharmaceutical administration law and relevant regulations of the drug registration management measures to deal with.
Varieties of has been listed in the administration of combining comprehensive evaluation conclusion, questioning by the letter of the law, rectification within a time limit and send warning letters, suspended the import customs clearance for the record, supervision, recall and sales suspension of risk control measures such as using, shall not be registered again.After the risk factors have been eliminated, relevant risk control measures should be removed in a timely manner.
Article 30. If the case is illegal, the general administration shall file an investigation and deal with it in accordance with the law.
Chapter v supplementary provisions
Article 31 the pharmaceutical manufacturers of the Hong Kong special administrative region, the Macao special administrative region and the Taiwan region shall carry out the provisions in accordance with these provisions.
Article 32 the import manufacturers in this regulation refer to the domestic agents, overseas production plants and research and development institutions that import the drug holders and their authorized authorized agents.
Article 33 the provisions of this regulation shall be interpreted by the state administration of food and drug administration.
Article 34 [implementation date] this regulation shall be implemented from the date of the month.
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