Clinical evaluation report service for overseas clinical trial data of drugs
According to the Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs issued by China Food & Drug Administration (NMPA)(No. 50 in 2018), the following requirements should be satisfied:
? The data of overseas clinical trials shall support the evaluation of efficacy and safety, and applicants for drug registration shall consider complying with the requirements for drug registration management in China.
? Key clinical trial data shall be evaluated to confirm the efficacy of the drug.
? Following the ICH requirements for the influence of ethnical factors (E5) while accepting clinical data from abroad, the consistency of the Chinese subgroup with the general world population shall be analyzed to support the extrapolation of overseas clinical trial results to the Chinese population.
? Data package in CTD format is encouraged.
The Hangzhou Tigermed Clinical Evaluation Center provides clinical evaluation reports for overseas clinical trial data of drugs, according to the applicable regulatory requirements. Our clinical evaluation reports include:
1. Biopharmaceutical data
All important in vitro or
in vivo data and results related to bioavailability (BA) and bioequivalence
(BE), providing support and data linkage for dosage form determination and
optimization of preparation processes during clinical research and development.
2. Clinical pharmacology data
All pharmacokinetic and pharmacodynamic study data. Following the requirements of ICH (E5) that defines the factors for acceptance of foreign clinical data, this also includes analysis of racial sensibility from multiple perspectives such as region and ethnicity, and the writing of the drug efficacy and safety assessment report for the applicability of overseas clinical trial data in China.
3. Efficacy data
All domestic and foreign key clinical trial data at to confirm overall efficacy of the investigational drug consistency of the Chinese subgroup with the general world population.
4. Safety data
All domestic and foreign clinical trial data for safety assessments to confirm overall safety and consistency of Chinese subgroup with the general world population.
Clinical evaluation reports for medical devices
According to the China State Council Order no.680 Regulation for the Supervision and Administration of Medical device and NMPA Order no.14 Technical Guidance for Clinical Evaluation of Medical Devices, NMPA Order no. 13 in 2018 Technical Guideline for Accepting Overseas Clinical Trial Data of Medical Devices,catalogs of medical devices exempted from clinical trial and related guidelines for technical review of medical device registration, Hangzhou Tigermed Clinical Evaluation Center provides the following clinical evaluation reports for medical devices:
? Clinical evaluation report for comparison between the study medical device and predicate product.
? Exempting report to compare the study medical device with both the exempting catalogue and similar product in the exempting catalogue.
? Clinical evaluation report on overseas clinical trial analysis of medical devices includesthe required analysis evaluation content for overseas trial data filing from multiple perspectives such as racial differences, differences in clinical trial conditions, and compliance of the overseas clinical trial with the laws and regulations of China.