NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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Achievements

Pilot Products

2022.03 12
Latest News! Pilot Drugs Included into Lecheng’s Real-world Data Application Increased to Nine
Recently, 5-Aminolevulinic Acid Hexyl Ester Hydrochloride injection produced by Photocure ASA Company has been included among the pilot drugs, making the number of pilot drugs in Lecheng’s real-...
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2022.03 09
Johnson&Johnson Catalys Precision Laser System Approved and Introduced with Real-world Data
On November 26, as reviewed by the NMPA, the registration of Johnson&Johnson Vision Catalys precision laser system was approved, which was the second innovative medical product to be approved base...
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2022.03 05
Two Products of Boston Scientific of the US Approved for Registration with Real-world Data of Lecheng
On March 3, the pilot program of real-world data application of Lecheng witnessed a new breakthrough. The NMPA reviewed and approved the registration application of thermal steam treatment equipment a...
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2021.03 24
NMPA Conditionally Approves the Marketing of Pralsetinib Capsule
Recently, through the prioritized review and approval procedure, the NMPA conditionally approved the marketing of Pralsetinib capsule, a Class 1 innovative drug declared by Blueprint Medicines Corpora...
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2020.03 26
The First Medical Product Approved for Marketing with Domestic Real-world Data
On March 26, the NMPA reviewed and approved the registration of XEN Glaucoma treatment system of the US Allergen Company.In order to promote the reform of China’s medical device evaluation and a...
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