A delegation led by Gu Gang made a visit to the Center for Drug Evaluation, NMPA, aiming to build Lecheng into a highland of global real-world research

Updated: January 17, 2022 L M S

On January 12, 2022, a delegation, led by Gu Gang, Party Secretary and Director of Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, and Zhu Ning, Director of Hainan Medical Products Administration, made a visit to NMPA Center for Drug Evaluation (hereinafter referred to as “CDE”), communicating and exchanging with Kong Fanpu, Director of the CDE, on the major work, and expressed the hope to further strengthen the cooperation between both sides in terms of the “Everlasting” Drug and Device Exhibition, clinical real world data research, etc.

First of all, Director Gu Gang paid his tribute and thanks to the CDE for its outstanding contributions to the national epidemic prevention and control and the people's health in respect of the approval of COVID-19 vaccines and special drugs last year under the pressure of the normalization of national epidemic prevention and control. In 2021, the CDE evaluated 46 innovative drugs for marketing, which hit a record high, close to the best level of the world's advanced regulatory agencies.

With the support of the CDE, Lecheng has also made remarkable achievements. The number of varieties of drugs covered by Lecheng Special Drug Insurance has been further increased, and with the launching of inclusive health insurances developed in cooperation with more than ten provincial and municipal medical insurance bureaus, the number of participants has reach a new high, showing a good diversion effect. Last year, the use of licensed drugs and devices in Lecheng Pilot Zone was greatly increased, significantly enhancing patients’ sense of gain and happiness. With the opening of Ruijin Hainan Hospital and the accelerated construction of West China Lecheng Hospital, Lecheng will further enhance its capacity for introducing more licensed drugs and devices, which will lay a better foundation for the development of clinical real-world research.

Director Gu Gang expects that the CDE will guide the establishment of a drug evaluation and approval demonstration area in Boao Lecheng's "Everlasting" Drug and Device Exhibition, and build it into an important contact point and demonstration base between Lecheng and the CDE, and that both sides will continue to consolidate the pilot mechanism of drug real-world data application, strengthen exchanges and training, and strive for more drugs to be approved for marketing through the pilot real-world data application program.

Kong Fanpu, Director of NMPA Center for Drug Evaluation, said that Lecheng Pilot Zone has established a good foundation in the early stage and has bright prospects for future development, and that the CDE will continue to support the development of Lecheng Pilot Zone by: first, supporting the “Everlasting” drug and device exhibition to show the world the results of China's innovative drug evaluation and approval; second, making full use of the pilot mechanism of drug real-world data application, giving full play to the role of research hospitals and other medical institutions, promoting the marketing of more drugs by using real-world data in the fields of children's drugs, rare disease drugs and traditional Chinese medicine, and jointly advancing academic research with the drug regulatory science base to support the construction of Hainan Lecheng into a global real-world research highland; and by supporting more training activities in Lecheng Pilot Zone, and making Lecheng become a hot spot for drug research, development, exchange and training.

Zhou Siyuan, Vice Director of NMPA CDE, heads of relevant departments, and heads of relevant departments of Hainan MPA and Lecheng Pilot Zone Administration attended the symposium.