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Pre-clinical Drug's Research of Medicilon

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Medicilon’s pre-clinical research services include:

  • Drug synthesis process

  • Drug extraction method

  • Drug purity

  • Prescription screening (pre-prescription research)

  • Drug preparation process

  • Physical and chemical properties of medicine

  • Drug dosage form selection

  • Inspection method, quality index

  • Stability monitoring;

  • Pharmacological research, toxicological research

  • Experimental research on animal pharmacokinetics

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Phone: 021-58591500

Regulatory Content

Article 16 The pre-clinical research of drugs for the purpose of applying for drug registration includes the synthesis process, extraction method, purity, prescription screening, preparation process, physical and chemical properties, dosage form selection, inspection methods, quality indicators, stability; pharmacology, Experimental research on toxicology and animal pharmacokinetics. Traditional Chinese medicine preparations should also include the source, processing and processing of the original medicinal materials; biological products should also include strains or starting materials, manufacturing verification procedures, etc.

Article 17 The “Non-clinical Drug Research Quality Management Standards” must be implemented to conduct drug preclinical safety evaluation research. Relevant management regulations must be implemented for pharmacodynamics and pharmacy research.

Article 18 Institutions engaged in drug research and development must have personnel, sites, equipment, instruments, conditions and management systems that are compatible with the experimental research project; the experimental animals, reagents and raw materials used should comply with relevant national regulations and requirements, and should ensure The authenticity of all test data and information.

Article 19 The raw materials used in the research and development of pharmaceutical preparations must be provided by the pharmaceutical manufacturer that has the approval number of the drug for that variety. The use of imported APIs must be provided by overseas pharmaceutical companies that have the “Imported Drug Registration Certificate” or “Medicine Product Registration Certificate” for that variety.

Article 20 The applicant for drug registration entrusts drug research institutions, drug manufacturers or other scientific research institutions to conduct drug research or to conduct individual tests, testing, sample trial production, production, etc., and the entrusting party shall sign a contract with the entrusted party and provide Responsible for the authenticity of research data and information.

Article 21 Drugs for clinical research should be trial-produced and produced in drug manufacturing enterprises that have obtained the certification of “Good Manufacturing Practice for Drugs”. The trial-manufacturing and production process should comply with the requirements of the “Good Manufacturing Practice for Drugs”.
Drugs produced overseas for clinical research shall meet the requirements of the preceding paragraph, and the production unit shall be in compliance with the “Good Manufacturing Practice for Drugs” and relevant certification documents. The State Drug Administration may send personnel to conduct on-site inspections according to the needs of the review.

Article 22 Where a drug registration applicant uses the drug trial research materials provided by an overseas drug research institution as the drug registration application materials, it must be accompanied by a description of the items and page numbers of the information provided by the foreign drug research institution and proof of the situation. The government certification documents that the institution has legally registered abroad can only be used as the application materials for drug registration applications after being approved by the State Drug Administration. The State Drug Administration may dispatch personnel to conduct on-site inspections according to the needs of the review.

Article 23 The State Drug Administration and the Drug Administration of provinces, autonomous regions, and municipalities directly under the Central Government may conduct audits and inspections of research as needed, and require drug registration applicants or drug research institutions undertaking trials to comply with the items declared in the materials submitted by them. Methods and data are tested repeatedly, and personnel are assigned to assess the test process on site; it is also possible to designate a drug inspection agency or other drug research agency to perform repeated tests.
Those who refuse to conduct repeated drug trials as required shall be given a warning, ordered to make corrections, or disqualified for application.

Article 24 Preclinical research of drugs should be conducted in accordance with the relevant technical guidelines issued by the State Drug Administration.
Drug registration applicants can follow scientific and advanced evaluation methods and technologies to conduct experiments, but if the methods and technologies used are not widely adopted and scientifically proven, they can discuss their scientificity and feasibility with the State Drug Administration in advance.

Article 25 The development of narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs must be approved in accordance with relevant national regulations before proceeding.

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