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CDE Announces 92nd Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 92nd batch of reference preparations for generic quality and consistency evaluation (GQCE). This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the market. New AdditionsThe latest batch includes 33 new drugs and…
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CDE Releases 91st Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 91st batch of reference preparations for generic drug quality and consistency evaluation (GQCE). This update is part of the ongoing efforts to standardize and improve the quality of generic drugs in the country. New Additions and RejectionsThe latest batch includes 59…
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NMPA Releases 90th Batch of Reference Drugs for GQCE
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The National Medical Products Administration (NMPA) has released the 90th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch involves a total of 51 specifications. Details of the ReleaseThe 90th batch includes 42 new specifications and 9 specifications with modifications. This release is part of the…
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NMPA Releases 89th Batch of Reference Drugs for GQCE Work
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The National Medical Products Administration (NMPA) has released the 89th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch aims to enhance the quality and consistency of generic drugs in the market. Batch DetailsThe 89th batch includes 51 new specifications and 28 specifications with modifications. The…
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CDE Announces 90th Batch of Reference Preparations for GQCE
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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.…
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CDE Releases 89th Batch of Reference Preparations for Generic Quality Consistency
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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…
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NMPA Releases 85th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 85th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further standardizing the evaluation process for generic drugs. This release includes 44 new specifications and 16 specifications with modifications, indicating the ongoing evolution of the reference drug landscape. Details…
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NMPA Releases 84th Batch of Reference Drugs for GQCE and First Batch Stripped of Status
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The National Medical Products Administration (NMPA) has released the 84th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in the regulation of generic drug quality in China. Concurrently, the NMPA has also announced the first batch of reference drugs that have been stripped…
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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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Livzon Pharmaceutical’s Leuprorelin Acetate Microspheres Passes China’s GQCE
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China’s Livzon Pharmaceutical Group Inc., (HKG: 1513, SHE: 000513) has announced that its leuprorelin acetate microspheres for injection have successfully passed the generic quality consistency evaluation (GQCE) in China. Leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, is utilized in the treatment of prostate cancer and endometriosis. Originally developed by Japan’s…
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NMPA Expands Generic Quality Consistency Evaluation with 83rd Batch of Reference Drugs
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The National Medical Products Administration (NMPA) in China has announced the release of the 83rd batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 49 new specifications and 38 modified specifications, along with updates to the English names of certain drugs and the addition of…
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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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Easton Pharmaceutical Receives NMPA Approval for Generic Oxcarbazepine
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s oxcarbazepine. This neurogenic drug is now approved for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or…
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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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NMPA Releases 81st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 81st batch of reference drugs for generic quality consistency evaluation (GQCE) work, comprising a total of 84 specifications. This batch includes 44 new specifications and 40 specifications that have undergone modifications.- Flcube.com
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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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NMPA Releases 80th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 80th batch of reference drugs for generic quality consistency evaluation (GQCE) work, comprising a total of 58 specifications. This batch includes 44 new specifications along with 34 specifications that have undergone modifications.- Flcube.com
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China’s NMPA Releases 79th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) in China has released the 79th batch of reference drugs for Generic Quality Consistency Evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs in the country. This batch includes 64 new specifications and 34 modified specifications for…
