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CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
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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…
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NMPA’s CDE Issues Guidelines for Leveraging Real-World Data in Drug Regulation
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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…
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Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
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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…
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China’s CDE Releases 88th Batch of Reference Preparations for Generic Drug Evaluation
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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…
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NMPA’s CDE Prioritizes Marketing Filings for Innovative Drugs with Priority Review Status
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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,…
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NMPA’s Center for Drug Evaluation Issues New Guidelines for Domestic Transfer of Overseas-Produced Vaccines
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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,…
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CDE Launches CARE Plan to Streamline Rare Disease Drug Development
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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…
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China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
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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…
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China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
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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…
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China’s CDE Seeks Public Comment on Latest Generic Drug Reference Preparations
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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…
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China’s CDE Releases Draft Guidelines for CAR-T Cell Therapy Clinical Trials
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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…
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China’s CDE Launches Pilot Program for Electronic Drug Registration Filings
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The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China has issued a notification to initiate a pilot program for the electronic submission of drug registration materials via network transmission. This new initiative aims to complement the existing method of submission via CDs and enhance the efficiency…
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CDE Seeks Public Input on Latest Batch of Generic Chemical Reference Preparations
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The Center for Drug Evaluation (CDE), a key component of China’s National Medical Products Administration (NMPA), is currently soliciting public feedback on the 84th batch of chemical generic reference preparations. The consultation period will remain open until July 10, 2024. In this batch, the list comprises 27 new specifications that…
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China’s CDE Opens Consultation on 83rd Batch of Generic Chemical Reference Preparations
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The Center for Drug Evaluation (CDE), a key regulatory body in China, is currently in the process of soliciting public feedback on the 83rd batch of chemical generic reference preparations. This consultation period will remain open until June 24, 2024. The list under review encompasses 49 new specifications that are…
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China’s CDE Issues Draft Guidelines for Patient-Centric Rare Disease Drug R&D
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The Center for Drug Evaluation (CDE) has issued a notification regarding the patient-centric rare disease drug research and development (R&D) working plan filing guidelines and implementation framework. The document is open for public comments for a period of one month. The objective of these guidelines is to guide and assist…
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China’s CDE Reports Record High in Clinical Trials for Innovative Drugs in 2023
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The Center for Drug Evaluation (CDE) has released its annual report, highlighting the growth in clinical trials for innovative drugs in China for the year 2023. The total number of general drug clinical trial applications reached a record high of 4,000, marking a 26.1% increase from 2022. Among these, applications…
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CDE Seeks Public Comment on Latest Generic Chemical Reference Preparations
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The Center for Drug Evaluation (CDE), China’s regulatory body, is currently seeking public feedback on the 82nd batch of chemical generic reference preparations, with the consultation period scheduled to close on May 16, 2024. The list under review encompasses nine new specifications that are being considered for the first time,…
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GBA Center of NMPA Launches Filing Guidance for Pharmaceutical Enterprises
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The Guangdong-Hong Kong-Macau Greater Bay Area (GBA) Center for Drug Evaluation and Inspection, under the National Medical Products Administration (NMPA), has announced the commencement of filing guidance services for pharmaceutical R&D entities within the GBA. This initiative aligns with the Drug Registration Regulation, aiming to offer technical guidance, facilitate communication,…
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China’s CDE Issues Guidelines for Pediatric Drug Labeling Updates
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China’s Center for Drug Evaluation (CDE) has issued a notice outlining the “Detailed Rules for Adding Pediatric Medication Information to the Labeling of Listed Drugs.” The notice provides clarity on the procedural steps for updating pediatric labeling information on drugs. Under the new guidelines, originator companies are permitted to directly…
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China’s CDE Issues Guidelines for Semaglutide Biosimilar Clinical Trials with Weight Management Focus
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The Center for Drug Evaluation (CDE) in China has released a new set of Guidelines aimed at streamlining the design of clinical trials for semaglutide biosimilars, with a specific emphasis on weight management indications. These Guidelines are now open for public feedback for a period of one month, allowing stakeholders…
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CDE Streamlines Patent Dispute Resolution for Generic Drug Filings with New Online Submission Process
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The Center for Drug Evaluation (CDE) has announced a new initiative aimed at enhancing the efficiency of resolving patent disputes during the review process for generic drug market filings. Patent holders, stakeholders, and generic drug applicants can now directly submit applications for setting a waiting period, as well as acceptance…
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China’s CDE Issues Guiding Principles for ADC Research and Evaluation
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China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates (ADCs).” The document aims to standardize and guide the research, development, and regulatory submissions pertaining to ADCs. The guidelines are applicable to ADC products that are created…
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CDE Reports 35.84% Increase in Drug Filings for 2023 with Focus on Innovation and Rare Diseases
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The Center for Drug Evaluation (CDE) has released its annual drug review report for 2023, highlighting a continued increase in drug regulatory filings. The CDE accepted 18,503 filings of various types, marking a 35.84% year-on-year increase. Within this figure, 3,745 filings required no technical review for direct administrative approval, an…
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China’s CDE Releases Guidelines for CGT Clinical Trials Communication
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The Center for Drug Evaluation (CDE) in China has released the “Technical Guiding Principles for Cell and Gene Therapy (CGT) Product Clinical Communication and Exchange,” addressing the unique considerations of personalized and specific CGT products. Applicants are advised to focus on critical factors such as product characteristics, clinical positioning, target…
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China’s CDE Issues Draft Guidelines for Overseas Drug Market Approval Filings
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China’s Center for Drug Evaluation (CDE) has unveiled a draft set of “Application Material Requirements” aimed at streamlining the market approval process for drugs that are either listed overseas and subsequently transferred to domestic production or are therapeutic biologic products. The draft, which is open for public consultation for a…
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CDE Requests Feedback on 77th Batch of Chemical Generic Reference Preparations by December 20
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The Center for Drug Evaluation (CDE) is currently soliciting feedback on the 77th batch of chemical generic reference preparations, with a deadline set for December 20, 2023. This batch includes 26 new specifications and 57 additional specifications. However, 18 specifications did not pass the review process, primarily due to issues…
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China’s CDE Releases Draft Guidelines for Decentralized Trials in Rare Disease Drug Development
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China’s Center for Drug Evaluation (CDE) has released draft “Technical Guidelines for the Application of Decentralized Clinical Trials in Rare Disease Drug Clinical Research and Development,” open for public feedback for one month. The guidelines have been formulated by a research team that extensively reviewed the guidance and suggestions from…
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CDE Releases 76th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference preparations, which includes 11 new specifications, 16 additional specifications, and updates to 22 previously published specifications. The updates encompass the addition of domestic generic names and Marketing Authorization Holder (MAH) information. Specifications Fail Review for…
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CDE Releases 75th Batch of Generic Reference Preparations with Updated Specifications
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The Center for Drug Evaluation (CDE) has announced the release of the 75th batch of chemical generic reference preparations. This update includes the addition of 14 new specifications and the expansion of 68 existing specifications. Additionally, 16 previously published specifications have seen their Marketing Authorization Holder (MAH) information updated. Review…
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CDE Introduces New Guidelines for Generic Drug Quality and Efficacy Consistency Evaluation
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The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the Acceptance and Review of Quality and Efficacy Consistency Evaluation of Generic Drugs.” Although described as a draft proposal with a one-month feedback period from the date of issuance, the guidelines are set to take immediate…
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CDE Releases 74th Batch of Generic Reference Preparations with 58 New Specifications
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The Center for Drug Evaluation (CDE) has released the 74th batch of chemical generic reference preparations, marking a significant update to the list with the addition of 24 new specifications and an increment of 34 specifications in total. Review Outcomes and Specification DetailsEleven specifications did not meet the review criteria…
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Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
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The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
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China’s CDE Proposes Removal of Ambroxol Inhalation Solution and Four Other Drugs
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The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference Preparation Adjustment List, inviting public feedback on the draft proposal before the deadline of October 7, 2023. The list proposes the removal of Ambroxol inhalable solution and four other varieties, totaling nine specifications. Specific Drugs…
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NMPA Drafts Quality Management Norms for Online Medical Device Sales
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The National Medical Products Administration (NMPA) has issued the “Medical Device Online Sales Quality Management Norms (draft proposal)” and is soliciting public feedback until October 14. This document outlines the fundamental requirements for quality management in the online sales process of medical devices, ensuring that the burgeoning e-commerce sector adheres…
