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Acceptance of overseas clinical trial data in China
Nora Yuan
Patent Attorney
Chemistry & Biotechnology Department
Welcome to Linda Liu & Partners on air！
The topic for today is the guidelines for acceptance of overseas clinical trial data in China. This guideline was first issued by National Medical Products Administration(NMPA) in July, 2018 as a further step to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices". Also, this guideline provides technical guidance for applicants who would like to use overseas clinical trial data for registration in China and may reduce redundancy of clinical trials which are usually take much time and money.
As is known to those skilled in the art, clinical trial data is the most important part in the process of drug approval. Before this guideline was issued, foreign pharmaceutical companies were required to conduct clinical trials in China even if some of the drugs had been sold in overseas markets for years, and a complete set of clinical trials usually took 5 to 10 years from the very beginning to the final approval.
Such cases also cause trouble for foreign pharmaceutical companies since they usually need to file the corresponding patent application much earlier than submitting application to NMPA to avoid patent infringement. However, if the patent is granted well before the drug approval, then the period of protection for the drug is actually shortened.
Now, with this new guideline, foreign pharmaceutical companies may attempt to submit some overseas clinical trial data so as to accelerate the drug approval process as well as saving time and money.
However, it should be noted that the requirements set by the guideline are rather strict for the moment. First, overseas clinical trail data shall be authentic, scientific, reliable and traceable, the generation process of these clinical data should comply with ICH GCP (International Council for Harmonization-Good Clinical Practice). Secondly, the applicant shall provide the complete trial data instead of selected data, the relevant data should at least include biopharmaceutical data, data for clinical pharmacology, and data for safety evaluation. Also, the applicants shall follow the ICH's requirements regarding racial influence factors, that is, the consistency between the Chinese subgroup and the general population should be analyzed to support the extrapolation of overseas clinical trial results to Chinese population. Finally, it may be relatively easy for drugs used for severe diseases, rare diseases and pediatric diseases to take advantage of this guideline and facilitate the approval process. Even if the current overseas clinical data cannot be fully accepted, these drugs may be allowed to submit further supplementary data regarding effectiveness and safety after launched in the market.
Overseas clinical trial data may be fully accepted, partially accepted or not accepted by NMPA, which may depends on the integrity and reliabilityof the dataand some other factors which may influence the pharmacodynamics and toxicology in Chinese population.
That's all for my topic. Feel free to contact me if you have any questions. As a leading patent law firm in China, we are always glad to help. See you next time!
