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Interpretation of quality control regulations for clinical research of drugs

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I. the background of the revision of the standard

In 2003, the State Food and Drug Administration promulgated "the GLP" (original Council Decree No. second), to regulate trade behavior, promote drug research and development, to ensure the quality of drugs has played a positive role in promoting.

With the rapid growth of the number of ability to continuously improve the safety evaluation of China's non clinical drug and non drug evaluation, and the application of new concept of clinical research in the field of production and new technology, the need for GLP content adjustment and refinement, in order to meet the needs of the development of the industry and supervision work.

In order to further implement the "opinions of the State Council on the reform of drug and medical device review and approval system" (Guo Fa 2015 No. 44), to meet the needs of the development of drug non clinical safety evaluation, with reference to international practices, administration organization revised the "drug non clinical research quality management specification" (hereinafter referred to as the "standard").

Two, "norms" applicable scope

The standard applies to the study of nonclinical safety evaluation of drugs for the registration of drugs. The relevant activities of non clinical safety evaluation of drugs should be observed in accordance with this regulation. Preclinical research activities such as drug metabolism and biological sample analysis for the purpose of registration are carried out in accordance with the code.

Three, the "norms" for comment

From August 17, 2016 to October 18th, the "standard" to the public for comments, received feedback from all parties 178, the General Administration in conjunction with feedback made changes.

In the process of revision, reasonable opinions and suggestions were adopted, and 6 main items were summed up:

(1) to supplement and clarify the term definitions involved in multi site studies;

(two) for the computerized system, the audit trails are adjusted to audit trails, and the terms and definitions of electronic data are defined;

(three) increase the terminology definition and sampling requirements for test objects and reference products;

(four) for pathological reviews, additional terminology definitions and specific requirements are defined;

(five) for the period of file management and storage is further defined;

(six) the importance of quality assurance is further strengthened, and additional quality assurance instructions are added.

The rejected opinions were summed up in 3 items:

(1) to retain the contents of the original "specifications" approved by the head of the organization in the original "norms". Reference to international practice, the approval of the pilot program is the responsibility of the project leader, is conducive to the realization of their rights and responsibilities consistent. The idea was not accepted.

(two) it is recommended that the research institutes be removed to ensure that the research institutes regularly participate in necessary laboratory testing, proficiency testing and comparison activities. Laboratory proficiency testing and comparison is an effective method to ensure the reliability of the clinical data of non clinical safety evaluation institutions, and should participate in the necessary capability verification and comparison activities according to the research needs. The idea was not accepted.

(three) recommend the removal of the client's chapters and contents. The principal research work as the initiator and the results of applicants, responsible for research data registration, should bear the responsibility of human rights, and the relevant state laws and regulations, for non clinical study of drugs were the principal with clear responsibilities. The idea was not accepted.

Four, "norms" revised content

(a) "standard" from the original 45 to 50, delete the original "standard" in the "inspection" section, the new "terms and definitions", "experimental system", "quality assurance" and "principal" section.

(two) the work style and professional ethics of the staff members in the former regulations have been cancelled, and the restriction on the educational background and educational background of the heads of the institutions has been cancelled.

(three) the main contents of the adjustment:

1. of the original "standard" for quality assurance responsibility for quality assurance personnel adjustment requirements and quality assurance department responsibilities, clear quality assurance department is responsible for the inspection of the implementation of this specification, in order to ensure the operation of management research conforms to the requirements of this specification.

2. data file retention period from the original "standard" "drug for at least five years after listing" adjustment "for the study of registration materials, the filing period should be listed in the drug after at least five years; not used to study the application materials (such as termination of registration), at least five years of the archives for days after the approval of the summary report; other information does not belong to the research category of archives shall be kept for at least ten years after its formation".

3., the filing time of data files from the original "norms" after the end of the study was adjusted to "in the course of the implementation of the study or research after the completion of the timely filing, the longest is not more than two weeks."".

(four) the main content of the increase:

1., the study of non clinical safety evaluation of drugs should be conducted to ensure that behavioral norms, data are truthful, accurate and complete.

A 2. increase in the non clinical research quality management standard, multi site research, institutions responsible person, the main researchers, standard operating procedures, master schedule, test plan, test plan change, deviation, solvent, the start of the study to define the term date, on completion date, computerized system, verification, electronic data, electronic signature and check track and peer review.

3., increase the staff to be responsible for the quality of raw data, and according to the needs of the job, take the necessary protective measures requirements.

4. increased agency heads (including multiple site studies)


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