On 6 July 2018, the China Food and Drug Administration (“CFDA”) issued the Technical Guiding Principles for the Acceptance of the Overseas Clinical Trial Data of Drugs (“Guiding Principles”) effective as of 6 July 2018 in order to further expedite drugs registration in China. The Guiding Principles apply to overseas clinical data to be submitted by drug registration applicants for the registration of new drugs and/or generic drugs in China. The Guiding Principles clearly list the basic principles and requirements on the acceptance of overseas clinical trial data, and distinguish different levels of acceptance based on the quality of the data itself and different circumstances.
It is worth noting that, from the issuance of the Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices by the General Office of the State Council on 7 October 2017, the CFDA has further issued a series of measures in order to expedite the process of drug registration in China, including measures to expedite the approval procedures for drug registration and changing clinical trial application. These Guiding Principles are aimed at implementing such measures and also lowering the costs to launch drugs onto the Chinese market by multinational pharmaceutical companies.
Below is a summary of the key points of such Guiding Principles.
1. Emphasize “Completeness” of the Overseas Clinical Trial Data
The Guiding Principles require that the applicant shall ensure that the overseas clinical trial data are “truthful”, “complete”, “accurate” and “traceable”. Among these requirements, “completeness” is the most fundamental requirement.
By “completeness”, the Guiding Principles emphasize that the applicant shall not provide partial clinical trial data by selection, but shall provide all overseas clinical trial data in relation to the drug to be registered in China. During the application for drug registration, both the domestic and the overseas clinical trial data shall be submitted in accordance with the Administrative Measures for Drug Registration and shall be compiled into a complete data folder. Specifically, such data folder shall contain biopharmaceutics data, clinical pharmacological data and data and materials related to the effectiveness and safety of the drugs to be registered.
2. Require that the Generating Process of the Overseas Clinical Trial Data Comply with ICH GCP Standards
The Guiding Principles also require that the generating process of the overseas clinical trial data shall comply with the relevant requirements of the Good Clinical Practice (“GCP”) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and that the clinical research quality shall not be lower than the standards listed under Guiding Principles. In case the clinical trial was carried out in a country or region where the respective GCP standards are lower than the ICH standards, or the clinical trial was carried out much earlier than the time of application in China, sufficient evidence shall be submitted to prove that the relevant clinical research quality complies with the relevant requirements.
The applicant shall also ensure that the design of the overseas clinical trial is scientific, the quality management system of the clinical trial itself complies with the requirements, and the statistics and analysis of the data are accurate and complete.
3. Distinguish Different Level of Acceptance of Overseas Clinical Trial Data
The Guiding Principles categorize the levels of acceptance of the overseas clinical trial data into three types:
(1) full acceptance;
(2) partial acceptance; and
Specifically, “full acceptance” applies to those clinical trial data which are truthful, reliable, complies with ICH GCP standards and the examination requirements for drug registration, having clinical research data supporting the relevant effectiveness and safety assessment, and without any ethnic-sensitive factors which may impact the effectiveness and safety. “Partial acceptance” applies to those clinical trial data whose effectiveness and safety assessment may result in relatively big uncertainties if the drugs are to be applied on the Chinese ethnicity. “Non-acceptance” applies to those data which have significant problems and cannot fully support the effectiveness and safety assessment for the target symptoms. For drugs which treat severe illnesses, rare diseases and/or pediatric diseases but currently lack effective treatment methods but meet the requirements for partial acceptance, the relevant overseas clinical trial data can also be accepted under certain conditions.