After the public consultation for the Technical Requirements for the Acceptance of Overseas Clinical Trial Data (Draft for comments), the China National Drug Administration (“CNDA”) issued the finalised Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (“Guiding Principles”) on 10 July 2018 (please click here to see our previous Law-Now).
The Guiding Principles generally follow the rules disclosed in the previous draft but provide greater detail.
Applicable scope of the Guiding Principles
“Overseas clinical trial data” that can be submitted for drug registration under the Guiding Principles includes, but is not limited to, data that is obtained in the overseas clinical trials of innovative medicines which are developed simultaneously in China and foreign countries, and the complete and evaluable bioequivalence data of generic drugs which are developed overseas.
The general principles that apply when accepting overseas clinical trial data
The applicant should make sure that the overseas clinical trial data is complete, true, accurate and traceable.
The generating process of the data should comply with Good Clinical Practice (“GCP”) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”).
The applicant should also ensure that the design of overseas clinical trial is scientific, the clinical trial quality management system is qualified and the data analysis is accurate and complete. For drugs which are simultaneously developed in China and overseas and that will have clinical trials carried out in China, the applicant can communicate with the Centre for Drug Evaluation of the CNDA (“CDE”) before conducting any key clinical trials to ensure that the clinical trial’s design complies with the basic technical requirements for drug registrations in China.
Requirements for the completeness of overseas clinical trial data
The applicant should provide all of the overseas clinical trial data when applying for drug registration in China. Selective data submission is prohibited.
Where the applicant has conducted early phase clinical trials abroad and then carried out clinical development in China, the applicant should evaluate the clinical trial data obtained in the earlier clinical trials. If this data is complete, the applicant can communicate with the CDE and submit the data to support the following clinical trials.
For drugs that have conducted all clinical trials abroad but have not yet been marketed, the applicant should submit a complete package of overseas clinical trial data. If the drug has been marketed abroad, the applicant should also submit updated data on safety and effectiveness.
Certain types of data shall be submitted in a required manner
For drugs that have simultaneous clinical development in China and abroad, the applicant should organise all the clinical trials conducted and produce a package of the complete clinical trial data, according to the requirements on application documents in the Administrative Measures for Drug Registration. The submitted overseas clinical trial data should include data on biopharmaceutics, clinical pharmacology, safety and effectiveness. The Guiding Principles encourage the applicant to use the Common Technical Document (CTD) format to submit the application materials.
The submitted data may be accepted, partially accepted or refused by the CNDA
Depending on the quality of the clinical trial data, the CNDA will fully accept, partially accept or not accept it.
- The CNDA will fully accept the overseas clinical data if:
- The data is true and reliable and meets the requirements of the ICH GCP and the requirements for drug registration in China;
- The data can support the effectiveness and safety evaluation of the targeted disease of the clinical trial; and
- The data does not include any racially sensitive factors that affect safety and effectiveness of the drug.
- The CNDA will partially accept the data if:
- The data is true, and reliable and meets the requirements of the ICH GCP and the requirements for drug registration in China;
- The data can support the effectiveness and safety evaluation of the targeted disease of the clinical trial; but
- The data includes some racially sensitive factors that affect the safety and efficacy of the drug.
The applicant should analyse the racially sensitive factors involved, communicate with the CDE and then carry out corresponding specific clinical trials.
If the overseas clinical trial data that is partially accepted is for drugs of critical and rare diseases or paediatric medication and the market currently lacks an effective treatment, the CNDA may accept the data conditionally and require further after-sale data on their safety and effectiveness.
- The CNDA will not accept the data if:
- The data has serious defects in its truthfulness, completeness, accuracy and traceability; or
- The data cannot support the efficacy and safety evaluation of the targeted disease of the clinical trial.
The applicant is required to conduct clinical trials in China to obtain qualified clinical trial data for a drug registration. Multi-national pharmaceutical companies will significantly benefit from the regime of accepting overseas clinical trial data defined in the General Principles; from the reduced cost of conducting clinical trials in China and the significantly reduced registration timeline.