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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…
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Easton Pharmaceutical Gets NMPA Nod for Generic Version of Merck KGaA’s Concor
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Concor, which contains bisoprolol and amlodipine, a compound preparation used as an alternative therapy for hypertension. The approval signifies that Easton’s…
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Guangzhou and Zhuhai Unveil Measures to Stimulate Biopharmaceutical Industry Growth
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In a bid to bolster the biopharmaceutical and health industries, the cities of Guangzhou and Zhuhai in Guangdong province have released Measures aimed at “Promoting High-Quality Development of the Biopharmaceutical Industry.” These policies are designed to refine the development environment and enhance the competitive edge of the sector. Guangzhou’s policy,…
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CDE Seeks Public Feedback on Latest Batch of Generic Drug Reference Preparations
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The Center for Drug Evaluation (CDE), a key regulatory body overseeing pharmaceutical evaluations in China, has issued a call for feedback on the 80th batch of chemical generic reference preparations. The public consultation period is set to conclude on March 29, 2024. This initiative is part of the CDE’s ongoing…
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NMPA Releases 78th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 78th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs. This batch includes 28 new specifications and 28 specifications with modifications, with 7 of these being…
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CDE Opens Consultation on 79th Batch of Generic Drug Reference Preparations
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The Center for Drug Evaluation (CDE) has issued a call for feedback on the 79th batch of chemical generic reference preparations, with the public consultation period set to end on March 5, 2024. This initiative is part of the CDE’s ongoing efforts to standardize and enhance the quality of generic…
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China’s NMPA Releases 77th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 77th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking another step in ensuring the quality and consistency of generic medications in the country. This batch includes 62 new specifications and 30 modified specifications for generic drugs, with…
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NMPA Expands Generic Drug Catalog with 74th and 75th Batches for Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 74th and 75th batches of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the catalog to enhance the standardization of generic drugs in the market. The 74th batch encompasses 32 newly added specifications along with 28 modified specifications,…
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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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Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
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Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
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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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Chongqing Lummy Pharmaceutical’s Generic Ramosetron Passes GQCE in China
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China-based Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006) has announced that its generic version of Astellas Pharma’s Nasea (ramosetron) has become the first to pass the generic quality and efficacy consistency evaluation (GQCE) process in China. The product received marketing approval in China in May 2005. Ramosetron’s Indications and Market…
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NMPA Unveils 73rd Batch of Reference Drugs for Generic Quality Consistency
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China’s National Medical Products Administration (NMPA) has released the 73rd batch of reference drugs as part of its ongoing Generic Quality Consistency Evaluation (GQCE) initiative. This batch includes 103 new specifications and 29 specifications with modifications, marking a significant step in the country’s efforts to enhance the quality and efficacy…
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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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NMPA Announces Pathway for Developing Generic Drugs Without Reference Preparation
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The National Medical Products Administration (NMPA) has issued an announcement regarding the development of generic drugs without a reference preparation, titled “Announcement on the Development of Generic Drugs with No Reference Preparation (No. 130 of 2023).” This new guideline addresses the process for drugs lacking a reference for generic quality…
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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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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…
