-
CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings
•
The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued growth in drug regulatory filings. The CDE accepted a total of 19,563 filings of various types, marking a 5.73% year-on-year increase. Filings BreakdownThe filings included 17,476 for drug preparations, up 3.42% YOY, and 2,087 for…
-
CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
•
China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its Support Anti-tumor drugs R&D for Kids (SPARK) project within one month. This initiative marks a significant step forward in promoting the development of pediatric antitumor drugs. Project BackgroundThe SPARK project is a pilot effort in…
-
NMPA’s New Guidelines for Drug Registration Review
•
A Look at the New Rules for Chemical and Biological Drug Filings in China:The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has released the “Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)” and “Guidelines for Acceptance and Review of Biological Product…
-
CDE Announces 90th Batch of Reference Preparations for GQCE
•
China’s Center for Drug Evaluation (CDE) has selected the 90th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. This batch adds 43 new drugs and 9 specifications to the list, reflecting the ongoing efforts to enhance the quality and consistency of generic drugs in the market.…
-
NMPA’s CDE Releases Draft Proposal for Benefit-Risk Assessment in Global Drug Development
•
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has issued the “Guiding Principles for Benefit and Risk Assessment Based on Multi-regional Clinical Trial Data in Global Synchronous Development of New Drugs (draft proposal)” and is soliciting public feedback for a period of two months. Consistency in…
-
CDE Releases 89th Batch of Reference Preparations for Generic Quality Consistency
•
The Center for Drug Evaluation (CDE) in China has announced the selection of the 89th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This process is crucial for ensuring that generic drugs meet the same high standards of quality and efficacy as their branded…
-
CDE Expands Care Plan with Approvals for Ractigen’s RAG-17 and Vitalgen’s VGR-R01
•
In a swift succession of actions, China’s Center for Drug Evaluation (CDE) has added two more rare disease drugs to its patient-centered rare disease drug development pilot program, known as the Care Plan. This follows three other approvals within a 10-day period. The latest inclusions are Ractigen Therapeutics’ RAG-17 and…
-
AstraZeneca’s ALXN1850 (Efzimfotase Alfa) Selected for China’s Rare Disease Care Plan
•
The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN1850, known as efzimfotase alfa, in the patient-centered rare disease drug development pilot program, referred to as the Care Plan. This move signifies a significant step forward in the global efforts to…
-
Jiangsu Chia Tai Fenghai’s ALS Treatment FHND1002 Selected for CDE’s Patient-Centered Care Plan
•
China’s Center for Drug Evaluation (CDE) has announced its intention to include Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. (CTFH)’s FHND1002 granules in the patient-centered rare disease drug development pilot program, known as the Care Plan. The official announcement is expected within the coming week. FHND1002: Focusing on Patient Experience…
-
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
•
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine and Sanofi (NASDAQ: SNY) Genzyme’s fitusiran in its patient-centered rare disease drug development pilot program, known as the Care Plan. Hydroxocobalamine for Metabolic Disorders in Children with MMAHydroxocobalamine, also referred…
-
NMPA’s CDE Issues Guidelines for Leveraging Real-World Data in Drug Regulation
•
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released the “Guidelines for Disease Registry-based Real-World Data Application (trial)”. These guidelines are designed to steer the utilization of real-world evidence (RWE) in supporting regulatory decisions related to drugs. Disease Registry and Data QualityThe document highlights…
-
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
-
China’s CDE Releases 88th Batch of Reference Preparations for Generic Drug Evaluation
•
The Center for Drug Evaluation (CDE) in China has announced its 88th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This selection is a critical step in ensuring the quality and efficacy of generic drugs within the Chinese market. Expansion and Refinement of Reference…
-
NMPA’s CDE Prioritizes Marketing Filings for Innovative Drugs with Priority Review Status
•
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released a notification last week, announcing that marketing filings for innovative drugs and varieties that have been confirmed to receive priority review and conditional approval statuses will be given precedence in processing, effective as of November 1,…
-
NMPA’s Center for Drug Evaluation Issues New Guidelines for Domestic Transfer of Overseas-Produced Vaccines
•
The Center for Drug Evaluation under the National Medical Products Administration (NMPA) has issued the “Requirements for Application Materials for Market Registration of Listed Drugs Produced Abroad and Transferred to Domestic Production (Preventive Biological Products),” which is set to take effect immediately. This new directive pertains to preventive biological products,…
-
CDE Launches CARE Plan to Streamline Rare Disease Drug Development
•
The Center for Drug Evaluation has unveiled the ‘Pilot Work Plan for Patient-Centered Action for Rare Diseases Encouragement (CARE),’ following a public consultation period in May 2024. The final document retains the initial proposal’s structure, segmenting the drug R&D lifecycle into stages A through E, with the anticipation of including…
-
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
•
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released a draft proposal titled “Questions and Answers on Pharmaceutical Similarity Research of Biosimilars,” seeking public feedback until October 9th. This document, applicable to Category 3.3 biologics, provides clarity on common issues and technical requirements for…
-
China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
•
China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for generic quality and consistency evaluation (GQCE), seeking public commentary until September 20, 2024. The latest draft opinion expands the list by incorporating 23 new drugs and 27 specifications, aiming to enhance the standardization and reliability…
-
China’s CDE Seeks Public Comment on Latest Generic Drug Reference Preparations
•
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) is currently in the process of soliciting feedback on the 88th batch of chemical generic reference preparations, with a deadline set for August 14, 2024. This initiative is part of the ongoing efforts to standardize and ensure…
-
China’s CDE Releases Draft Guidelines for CAR-T Cell Therapy Clinical Trials
•
The Center for Drug Evaluation (CDE) in China has issued a draft proposal for “Technical Guidelines for Clinical Trials of Chimeric Antigen Receptor (CAR)-T Cell Therapy for Malignant Tumors of the Lymphatic and Hematological System.” These guidelines are designed to provide a framework for the design, protocol, and execution of…
