On July 10, the State Drug Administration issued the Circular on the Issuance of Technical Guidelines for Acceptance of Overseas Clinical Trial Data (No. 52 of 2018) (hereinafter referred to as the “Notice”), reporting on drugs in China. At the time of registration, the applicant is given clear policy guidelines for the work of using overseas clinical trial data as clinical evaluation data.
According to the requirements of the Circular, the data of overseas clinical trials involved include, but are not limited to, the applicant's clinical trial data obtained overseas through the simultaneous development of innovative drugs at home and abroad; the development of generic drugs outside the country, with complete and evaluable bioequivalence For sexual data, it can also be used to register applications.
This means that generic drugs developed by multinational pharmaceutical companies can speed up the entry into the Chinese market. Local pharmaceutical companies can also take advantage of overseas clinical resources to further improve the research and development level of innovative drugs and generic drugs. It is worth noting that the Notice Emphasize that applicants should ensure the authenticity, completeness, accuracy and traceability of overseas clinical trial data; the process of generating clinical trial data should be in accordance with the International Conference on Human Drug Registration Technology (ICH) Clinical Trial Quality Management Regulations (GCP). Related requirements.
For the completeness of the data of overseas clinical trials, the Notice further clarifies that ensuring the integrity of clinical trial data is the basic requirement for accepting registration applications.
Among them, if the overseas clinical trial is used for Chinese drug registration application, all clinical trial data should be provided, and clinical trial data should not be provided selectively.
If there are overseas early clinical trials, and subsequent clinical research and development in the country, drug registration applicants should evaluate the early clinical trial data. If they have complete clinical trial data, they can be used to support follow-up clinical trials after communicating with the drug trial center.
For all clinical trials that have not been completed overseas, a complete offshore clinical trial data package should be provided.
If it is listed, it should also provide security and validity update data before it can be used for registration in China.
It is understood that China's review and approval method for 'accepting overseas clinical trial data' has been exploring, and its purpose is to accelerate the promotion of imported drugs in China.
In January 2015, the former State Food and Drug Administration issued the International Multi-Center Clinical Trial Guide, which guided the application, implementation and management of the International Multi-Center Clinical Trial (MRCT) in China with reference to internationally accepted principles such as ICH-GCP. China's sponsors carry out international multi-center drug clinical trials.
In October 2017, the two offices 'No. 42' encouraged enterprises with conditions to accept data from overseas multi-center clinical trials, speed up the internationalization of drug research and development, and improve drug accessibility.
On October 20, 2017, the “Technical Requirements for Accepting Overseas Clinical Trial Data (Draft for Comment)” was released, and the public's reasonable opinions were adopted. These include: Objective To change the quality of 'guaranteed clinical trial data' to 'ensure clinical trial design And data analysis is scientifically sound'.
It can be seen that the acceptability of clinical trials, the design of trial protocols, and the efficacy and safety of data results are becoming more and more important. Therefore, reducing the risk of clinical trials, increasing the success rate, meeting the needs of different national regulatory regulations and drug development, The problem that pharmaceutical companies must consider when developing.
The industry said that with the introduction and implementation of a series of policies, it not only benefits Chinese patients, but also brings new opportunities and challenges to multinational pharmaceutical companies and local pharmaceutical companies, driving local pharmaceutical companies to change their research and development model. Implementation will further accelerate the competition in the domestic market, or activate the development of innovative drugs that benefit China and the world.
