On July 10th, 2018, the China National Medical Products Administration (NMPA) officially issued the Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs. With the release of this Guidelines, the qualified overseas clinical trial data can be directly used for pharmaceutical registration in China, which makes the simultaneous R&D work of new drugs feasible inside and outside China, and reduce market cycles of new drugs in China.
According to the Guidelines, the clinical trial data should be provided with a Chinese translation copy. And the evaluation results of those overseas clinical trial data by China authority, depending on its data quality, are divided into “Fully accepted”, “Partially accepted” and “Not accepted”. The “Fully accepted” decision can be given if “the research data is reliable and in line with ICH GCP and drug registration requirements, supporting the effectiveness assessment and safety assessment of target indications. Additionally, there is no ethnic sensitivity factor that affect the drug’s effectiveness and safety”. The criteria of “Partially accepted” is “the research data is reliable and in line with ICH GCP and drug registration requirements, supporting the effectiveness assessment and safety assessment of target indications. However, there are some ethnic sensitivity factors which lead considerable uncertainty to the drug’s effectiveness and safety assessment on the Chinese population”. When the decision is given as “Partially accepted”, the applicant should carry out the clinical trial required by China Center of Drug Evaluation (CDE-NMPA). Before that, a deep discussion with CDE-NMPA about how the clinical trial should be conducted is necessary. However, if the drug registration applications are for critical illness, rare diseases, pediatrics lack of effective treatments, even the overseas clinical trial data is considered as “Partially acceptable”, it may be allowed to go public first and then continue collecting further effectiveness and safety information after the drug is marketed.
In addition, it also mentions in the Guidelines that the qualified overseas bioequivalence (BE) data of the generics, can also be used for drug registration in China.
It’s obvious that this Guidelines was released with the aim of promoting pharmaceutical industry development in China. Many policies and regulations published by China State Council, the National Health Commission and NMPA since 2016 with the same purpose. In terms of drug registration review, the CDE-NMPA has also accelerated the drug approval in China by expanding the reviewer team and workflow reforms. The current approval period of new drugs in China is close to that of the United States, EU and Japan. It’s a good news for international pharmaceutical companies, and also for Chinese local patients.