Center for Drug Evaluation
Business Services · Taiwan · 51-200 Employees
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Overview
Headquarters
3f no. 465 Sec.6 Zhongxiao E. Rd, Taipei...Phone Number
+886 281706000Website
www.cde.org.twRevenue
$20.9 MillionIndustry
About Center for Drug Evaluation
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Center for Drug Evaluation News & Media
Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for Treatment of Relapsed/Refractory Multiple Myeloma
Approval follows U.S. FDA clearance of IND application for BCMA/CD19 dual-targeting FasTCAR-T GC012F Company plans to initiate Phase 1/2 clinical trial in China in third quarter of 2023 SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Feb. 13, 2023 /PRNewswire/ -- Gracell Biotechnologies...Zai Lab Announces NDA for Sulbactam-Durlobactam (SUL-DUR) Granted Priority Review by China’s NMPA
SHANGHAI and CAMBRIDGE, Mass., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR) for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains.InnoCare Announces Approval to Conduct a Phase II Clinical Trial of Orelabrutinib in Combination with Tafasitamab + Lenalidomide in China
BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428) announced today that the Company has received approval from the Center for Drug Evaluation (CDE) to conduct a single-arm, open-label, multi-cohort phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with tafasitamab + lenalidomide for the treatment of patients with relapsed or refractory Non-Hodgkin's lymphoma (NHL). Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “We arNuance Pharma Announces Clearance of IND Application for Respiratory Syncytial Virus (RSV) Vaccine in China
SHANGHAI, Nov. 13, 2022 /PRNewswire/ -- Nuance Pharma ("the Company") announces the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal phase III clinical trial of MVA-BN RSV vaccine against respiratory syncytial virus...
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Frequently Asked Questions Regarding Center for Drug Evaluation
Our missions: The vision of the Center for Drug Evaluation is "Regulatory Science, Service for Life". Our missions: In response to the country policy, develop regulatory environment, draft regulations and guidance that meet the international norms, and offer consulting services for industries so as to facilitate the development of new drugs and med... Read More