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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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NMPA Issues Interim Provisions for Overseas MAHs’ Designated Domestic Responsible Persons
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The National Medical Products Administration (NMPA) has released the “Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders (MAHs)”. These provisions are designed to strengthen the management of overseas drug MAHs and to delineate the rights and responsibilities of these entities and their…
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NMPA Draft Proposal Aims to Strengthen Supervision of Drug Entrusted Manufacturing
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The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement on Strengthening the Supervision and Management of Drug Entrusted Manufacturing (draft proposal)” and is soliciting public feedback until December 10, 2024. This initiative aims to enhance the oversight and management of drug manufacturing processes where production is…
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China’s NMPA Issues Guidelines for Domestic Manufacturing of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification aimed at further clarifying the regulations surrounding the manufacturing of imported medical devices by companies within China. The document is open for public feedback until December 2, 2024. Requirements for Domestic Production of Certified Imported DevicesThe document stipulates that for…
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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 NMPA and Denmark’s Medicines Agency Commit to Enhanced Regulatory Cooperation
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The National Medical Products Administration (NMPA) of China and the Danish Medicines Agency have signed a Letter of Intent for cooperation in the field of medical devices and pharmaceutical regulation. The agreement was formalized in Beijing between Li Li, the head of the NMPA, and Mette Eberhard Hansen, the acting…
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China’s NMPA Launches Pilot Program for Phased Manufacturing of Biological Products
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The National Medical Products Administration (NMPA) has officially released the “Pilot Work Plan for Phased Manufacturing of Biological Products,” which is set to take effect immediately and continue through December 31, 2026. The plan calls for applicants and drug registration holders interested in participating in the pilot program to submit…
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China’s NMPA Greenlights Pilot Plan for Phased Manufacturing of Biological Products
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The National Medical Products Administration (NMPA) has given its stamp of approval to the “Pilot Work Plan for Phased Manufacturing of Biological Products,” a document that outlines a comprehensive framework for the phased production of certain innovative and urgently needed biological products through contract manufacturing. The plan, anticipated to be…
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NMPA Sets Forthcoming Guidelines for Domestic Drug Refiling Procedures
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The National Medical Products Administration (NMPA) has issued a notification outlining the requirements for the refiling procedures and materials for domestically produced drugs, which will come into effect on January 1, 2025. The document mandates that marketing authorization holders (MAHs) of these drugs and registrants of chemical raw materials must…
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China’s NMPA Proposes Rewards for Internal Whistleblowers in Drug and Medical Device Safety Reporting
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The National Medical Products Administration (NMPA) of China has issued a draft proposal for the “Notice on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices.” The bureau is seeking public feedback from October 10 to November 9, 2024. This initiative encourages entities…
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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 Unveils Medical Insurance Eligibility Management System for Designated Healthcare Personnel
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The National Healthcare Security Administration (NHSA), National Health Commission, and National Medical Products Administration (NMPA) have jointly issued guidelines aimed at establishing a medical insurance payment eligibility management system for personnel at designated medical institutions. This initiative pertains to individuals at such institutions who are involved with the use of…
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China’s NMPA Releases Standards for Brain-Computer Interface Medical Devices
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The National Medical Products Administration (NMPA) in China has issued a notification confirming the establishment of two new standards related to medical devices utilizing Brain-Computer Interface (BCI) technology. The first standard, titled “Terminology and Definitions for Medical Devices Using Brain Computer Interface (BCI) Technology,” aims to provide a clear framework…
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GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
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The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
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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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South Korea’s MFDS Aims to Slash Drug Approval Times with New Innovation Plan
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South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled an ambitious plan to expedite its drug review and approval process, as reported in a recent press briefing. The “New Drug Approval Innovation Plan” targets a significant reduction in the timeline for novel drug reviews to under 300 days,…
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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 Opens Doors to Foreign Biotech and Wholly-Owned Hospitals in Healthcare Sector Expansion
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China’s Ministry of Commerce, National Health Commission, and National Medical Products Administration (NMPA) have jointly released a “Notification on Carrying out Pilot Work to Expand the Opening Up of the Medical Field,” signaling a significant shift in the country’s healthcare landscape. The notification outlines measures aimed at further opening up…
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NMPA Unveils 82nd Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has announced the release of the 82nd batch of reference drugs for its Generic Quality Consistency Evaluation (GQCE) program. This latest batch includes 25 new specifications and modifications to 8 existing ones, featuring a drug with a newly changed generic name, enarodustat, along with…
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China’s NMPA Suspends Dr. Reddy’s Atomoxetine Imports Amid Quality Concerns
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BEIJING—The National Medical Products Administration (NMPA) has issued a notification to immediately suspend the import, sales, and use of Dr. Reddy’s Laboratories Ltd.’s atomoxetine hydrochloride capsules in China. The decision comes after the Indian pharmaceutical company’s product, which won a bid in the 9th round of China’s volume-based procurement (VBP),…
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NMPA Suspends Jeisys Medical Inc.’s Nd:YAG Laser Equipment Over Quality Concerns
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BEIJING—The National Medical Products Administration (NMPA) of China has issued a notification to immediately suspend the import, operation, and use of Nd:YAG laser surgery equipment manufactured by South Korea-based Jeisys Medical Inc. The decision comes in the wake of a remote non-site inspection, which revealed critical deficiencies in the company’s…
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China’s New Medical Device Regulations: A Comprehensive Framework for Industry Growth and Safety
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BEIJING—China’s National Medical Products Administration (NMPA) has unveiled a draft proposal for the “Medical Device Management Law of the People’s Republic of China,” seeking public input until September 28. The law aims to regulate the entire spectrum of medical device activities, from research to supervision, within the nation’s borders. The…
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China’s NMPA Proposes New Rules for Export Drug Manufacturing and Management
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The National Medical Products Administration (NMPA) of China has issued a new set of regulations concerning the administration and management of export drug manufacturing, with a public consultation period open until September 10, 2024. The regulations define export drugs as those manufactured by Chinese companies and intended for export to…
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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 NMPA Launches Pilot Programs in Beijing and Shanghai for Innovative Drug Approvals
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The National Medical Products Administration (NMPA) of China has given the green light to Beijing and Shanghai to initiate pilot programs aimed at streamlining the review and approval process for innovative drug clinical studies. Announced via an official notice, the NMPA has decided to implement a pilot review and approval…
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China’s NMPA Approves Pilot Plan to Streamline Clinical Trial Reviews for Innovative Drugs
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In a meeting chaired by Party Secretary and Director of the National Medical Products Administration (NMPA) Li Li on July 30, 2024, the “Pilot Work Plan for Optimizing Clinical Trial Review and Approval of Innovative Drugs” was given the green light. The initiative aims to enhance the quality and efficiency…
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China Expands Controlled Substances Catalogue to Include Three Additional Substances
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The Ministry of Public Security, National Health Commission, and National Medical Products Administration in China have announced the inclusion of bromocaffeine, metonitazene, and etonitazene among a total of 46 substances in the Supplementary Catalogue of Controlled Varieties of Non-Medicinal Anesthetic Drugs and Psychotropic Drugs. This action is in accordance with…
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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 NMPA Unveils Three-Year Smart Supervision Plan for Blood Product Industry
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China’s National Medical Products Administration (NMPA) has unveiled the “Three-Year Action Plan for Smart Supervision of Blood Product Production (2024-2026),” with a strategic focus on enhancing the digital management of blood product manufacturers. The initiative aims to elevate the supervision of blood products and ensure their high quality and safety…
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China’s NMPA Issues New Supervision Measures for Medical Device Clinical Trials Starting October 2024
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The National Medical Products Administration (NMPA) has approved the “Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial),” with the regulation set to take effect from October 1, 2024. These measures are designed to reinforce the critical role of clinical trials in confirming the safety and…
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China Unveils Comprehensive Plan to Tackle Unhealthy Practices in Pharma and Healthcare
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The National Health Commission (NHC), National Healthcare Security Administration (NHSA), National Medical Products Administration (NMPA), and a total of 14 ministries have issued the “Key Points for Correcting Unhealthy Practices in the Field of Pharmaceutical Procurement and Sales and Medical Services in 2024.” The document aims to address key personnel…
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Beijing Unveils Action Plan to Boost Pharmaceutical and Health Industry by 2026
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The Beijing People’s Government has issued an “Action Plan” outlining measures and targets to “Accelerate Collaborative Innovation in Medicine and Health” over a three-year period from 2024 to 2026. Many of these measures were previously outlined in a draft document reported in April 2024. The plan sets an ambitious goal…
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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 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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China and South Korea Reinforce Ties with Renewed MOU on Pharmaceuticals and Cosmetics Regulation
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The National Medical Products Administration (NMPA) of China and the Ministry of Food and Drug Safety (MFDS) of South Korea have renewed their Memorandum of Understanding (MOU) to enhance regulatory cooperation in the sectors of drugs, medical devices, and cosmetics. Originally established in 2019, the MOU aims to intensify exchange…
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ImmuneOnco Biopharmaceuticals’ CD47 Inhibitor Receives NMPA Go-Ahead for Phase III Trial
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for timdarpacept (IMM01), the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy…
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CSPC Pharmaceutical’s βKlotho Monoclonal Antibody JMT202 Receives Clinical Trial Approval from NMPA
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its βKlotho monoclonal antibody (mAb), JMT202. This molecule is intended to reduce triglyceride (TG) levels in patients…
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NMPA Seeks Public Comment on Draft Proposal for Drug Re-Registration Procedures
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The National Medical Products Administration (NMPA) of China has released a draft proposal for the “Notice on Issuing the Domestic Produced Drugs Re-registration Application Procedures and Application Materials Requirements.” The public is invited to provide feedback from May 13 to June 12. According to the draft notice, Marketing Authorization Holders…
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NMPA Updates In Vitro Diagnostic Reagents Classification List for Enhanced Regulatory Oversigh
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The National Medical Products Administration (NMPA) has coordinated the revision and release of the In Vitro Diagnostic Reagents (IVDs) Classification List, which will come into effect from January 1, 2025. The list includes IVDs regulated as medical devices, excluding those used for blood source screening and those labeled with radioactive…
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Hong Kong SAR and NMPA Renew Agreements to Boost Drug and Medical Device Regulation
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Professor Chung-mau LO, BBS, JP, Secretary for Health of the Hong Kong Special Administrative Region (SAR) government, held a meeting with Li Li, Director of the National Medical Products Administration (NMPA). The meeting focused on enhancing collaboration regarding drug and medical device approval processes, clinical trials, and the advancement of…
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China Upgrades Midazolam to Category I Psychotropic Drug List in Regulatory Rescheduling
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In a joint notification, the National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission (NHC) of China announced adjustments to the management categories of certain psychotropic drugs. Effective July 1, 2024, dextromethorphan, diphenoxylate, nalfurafine, and lorcaserin will be placed under Category II control. Concurrently, the active…
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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 NMPA Introduces 12 Measures to Strengthen Drug Operation Administration
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The National Medical Products Administration (NMPA) has issued a notification with 12 measures aimed at enhancing the administration and management of drug operations, effective immediately.
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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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China’s NMPA Launches 2024 Medical Device Industry Standard Revision Plan
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The National Medical Products Administration (NMPA) has unveiled the “2024 Medical Device Industry Standard Revision Plan Project,” calling for the participation of medical products administration bureaus from key provinces and cities, including Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, and Guangdong, as well as Guangzhou city. The National Institutes…
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NMPA Mandates Electronic Permits for Anesthetic Drugs and Psychotropic Substances
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The National Medical Products Administration (NMPA) has issued a new notification aimed at enhancing the management of import and export licenses for anesthetic drugs and psychotropic substances. Effective immediately, applicants for such permits are required to submit their application materials and supplementary materials in electronic form, eliminating the need for…
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China’s National Adverse Drug Reaction Report for 2023 Highlights Stability in Reporting Trends
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The National Center for ADR Monitoring has released its “National Adverse Drug Reaction Monitoring Annual Report (2023),” providing a comprehensive overview of the adverse drug reaction (ADR) landscape in China for the year. The National Adverse Drug Reaction Monitoring Network received a total of 2,419,000 ADR/Event Report Forms, with an…
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Shanghai Unveils 17 Measures to Enhance Medical Administration Business Environment
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Shanghai’s Medical Product Administration has unveiled a comprehensive set of 17 measures aimed at fostering a world-class business environment in the medical administration sector. The initiatives focus on enhancing service levels, advancing benchmarking reforms, and optimizing regulatory supervision. Key measures include:
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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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China’s NMPA Updates Rules for Administrative Penalty Discretions in Drug Supervision
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The National Medical Products Administration (NMPA) has issued the “Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration,” which will come into effect on August 1, 2024. These Rules, comprising 6 chapters and 54 articles, represent an enhancement of the 2012 version, with improvements in four…
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Fujian Province Issues Provisional Regulations for Managing Medical Representative Visits
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The Fujian provincial health commission and medical products administration have jointly issued the “Provisional Regulations on the Management of Reception of Medical Representatives by Staff of Public Medical Institutions in Fujian Province.” These regulations mandate that pharmaceutical representatives engaging in academic promotion activities related to their products within medical institutions…
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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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GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
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The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart (dutasteride) has been given the green light to resume import, sales, and use in China, effective from September 1, 2023. This follows a previous suspension due to an unsuccessful overseas site inspection by the NMPA…
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NMPA Launches Pilot Program to Streamline Supplementary Drug Approval Process
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The National Medical Products Administration (NMPA) has unveiled the “Pilot Work Plan for Optimizing the Review and Approval Procedures of Supplementary Drug Applications,” aimed at enhancing the efficiency of the drug review and approval process. This initiative seeks to streamline the supplementary filing review process for pharmaceutical companies. Under the…
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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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NMPA Proposes Streamlined Market Approval Process for Domestically Produced Overseas Drugs
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The National Medical Products Administration (NMPA) has released a draft proposal titled “Optimizing the Market Approval Filing Matters for Overseas Drugs Already Marketed in China to Be Manufactured in China.” The document is open for public feedback from January 25 to February 23, 2024. The draft proposal outlines several key…
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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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Suzhou Jade Biomedical Partners with Hopstem Biotechnology for Cell Therapy Advancements
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Suzhou Jade Biomedical Co., Ltd, a prominent player in the Chinese biotech industry, has entered into a strategic partnership with Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by a team of neuroscientists and stem-cell biologists from Johns Hopkins University. The collaboration aims to enhance the quality and…
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Shanghai Medical Products Administration Issues Trial Measures for Pharmaceutical Quality and Safety Personnel
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The Shanghai medical products administration has released the “Measures for the Management of Key Quality and Safety Management Personnel of Drug Production and Operation Enterprises in Shanghai (Trial)”. These measures aim to tackle current issues in managing key personnel responsible for drug quality and safety within enterprises and to bolster…
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China’s NMPA Issues Guidelines for Inspection of Third-Party Online Drug Trading Platforms
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The National Medical Products Administration (NMPA) has issued a new set of “Guidelines for the Inspection of Third-Party Drug Online Trading Platforms,” signaling an upcoming wave of regulatory scrutiny for enterprises offering such services. The NMPA aims to enhance oversight through a targeted round of supervision and inspection. The forthcoming…
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China’s NMPA Proposes Enhanced IT and Visualization Requirements for Blood Product GMP
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The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the revised draft proposal for the annex amendment of the Good Manufacturing Practice (GMP) standards for blood products. This updated version introduces new requirements focusing on information technology and visualization in the manufacturing and testing processes…
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China Releases Emergency Use Rules for Medical Devices Amid Public Health Emergencies
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The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease Control and Prevention (CDC) have jointly issued the “Medical Device Emergency Use Management Rules (trial),” which are effective immediately. These rules govern the emergency use of medical devices within a specified scope and period for…
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AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
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China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Acetabular Component of Hip Prosthesis, classified as a Class III medical device. This innovative product is a 3D-printed titanium alloy orthopedic implant. AK Medical first gained…
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China Medical System’s Methotrexate Injection Receives NMPA Review for Rheumatoid Arthritis Indication
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its methotrexate injection. The company is now seeking NMPA approval for the use of the drug in treating active rheumatoid arthritis (RA) in adults. Initially approved for…
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Huadong Medicine Gets NMPA Green Light for Sirolimus Real-World Study in Pediatric Epilepsy
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, parallel external control, retrospective real-world study. The study will assess the efficacy and safety of its Category 2.4 product, sirolimus, in epilepsy related to nodular sclerosis…
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Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Category 1 drug, Didaxini. This drug is a partial agonist of GABAA (γ-aminobutyric acid A) receptors and selectively targets the α1 subtype of…
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China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for CFT8919, a metamorphic BiDA degradation agent licensed from U.S. firm C4 Therapeutics, Inc. (NASDAQ: CCCC). The study will focus on…
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China’s NMPA Officially Seeks Membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced that China’s National Medical Products Administration (NMPA) is officially seeking membership. This move signifies the NMPA’s intention to enhance communication and cooperation with PIC/S, aligning with international pharmaceutical inspection standards. Historical Context and PIC/S OverviewPIC/S, formerly the Pharmaceutical Inspection Convention (PIC), was…
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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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NMPA Implements New Measures for Drug Manufacturing Outsourcing by MAHs
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The National Medical Products Administration (NMPA) has issued a notice detailing new supervision and management measures for the outsourcing of manufacturing duties by Marketing Authorization Holders (MAHs). These measures take immediate effect and aim to enhance the regulatory framework surrounding drug production outsourcing. Regulatory Requirements for OutsourcingApplicants seeking to outsource…
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NMPA Issues Guidelines for Temporary Import of Urgently Needed Medical Devices
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The National Medical Products Administration (NMPA) has released new “Management Requirements for Temporary Import and Use of Clinically Urgently Needed Medical Devices in Medical Institutions.” These guidelines are designed to address the special clinical needs of patients by allowing the temporary import and use of medical devices that have been…
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Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
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China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to…
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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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China’s New Drug Quality Management Measures to Take Effect in 2024
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The State Administration for Market Regulation (SAMR) has released the “Drug Operation and Use Quality Administration and Management Measures,” set to take effect from January 1, 2024. These measures will apply to the quality management and supervision of drug operation, use, and management activities within China, ensuring stringent standards for…
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China Releases First Supplement to 2020 Pharmacopoeia with 47 New Drug Varieties
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The National Medical Products Administration (NMPA) and the National Health Commission have announced the release of the first supplement to the Pharmacopoeia of the People’s Republic of China (2020 Edition), which will come into effect on March 12, 2024. This update marks a significant expansion and refinement of the country’s…
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NMPA and NHC Tighten Regulations on Etomidate and Modafinil
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The National Medical Products Administration (NMPA) and the National Health Commission (NHC) have jointly issued a notification aimed at enhancing the regulation of etomidate and modafinil. This follows last month’s announcement from the NMPA and other bureaus regarding the adjustment of the narcotics and psychotropic substances catalog, which downgraded modafinil…
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Hunchun Port Designated as Medical Materials Import Port by NMPA and GAC
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The National Medical Products Administration (NMPA) and the General Administration of Customs have jointly released a notification designating Hunchun Port in Jilin Province as a port for the import of medical materials. This designation signifies a strategic move to enhance the efficiency and management of medical imports in the region.…
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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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NMPA Seeks Comments on Medical Device Classification Draft Proposal
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The National Medical Products Administration (NMPA) has issued a notification focusing on the definition and classification of medical device products. The draft proposal is open for public comment until October 18, 2023, allowing stakeholders to provide feedback on the regulatory framework. Risk-Based Classification ProcessThe classification of medical devices involves an…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
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CDE Annual Report: Clinical Trials for Innovative Drugs in China Reach Record High
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The Center for Drug Evaluation (CDE) has released its annual report on clinical trials in support of innovative drugs in China for the year 2022. The report provides insights into the trends and developments in the clinical trial landscape for innovative drugs within the country. Record Number of Clinical Trial…
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NMPA Drafts Guidelines for Supervising Online Drug Exchange Platforms
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The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection Guidelines” for public review, with feedback accepted until September 15, 2023. These guidelines are designed to provide a framework for drug regulatory authorities to supervise and inspect enterprises offering third-party platform services in the pharmaceutical…
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Taizhou Port Designated as Drug Import Port by NMPA and General Administration of Customs
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The National Medical Products Administration (NMPA) and the General Administration of Customs have released a joint notification designating Taizhou Port in the city of Taizhou as a drug import port. This designation allows for the importation of certain Chinese medicines and chemicals, including narcotics and psychotropic drugs, through Taizhou. Enhanced…
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Li Li Appointed as New Director of NMPA
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The State Council has released an announcement regarding appointments and dismissals within the government. Among the changes, Li Li has been appointed to serve as the director of the National Medical Products Administration (NMPA), succeeding Jiao Hong who has left the position. Li Li’s Extensive Experience in Healthcare and AdministrationLi…
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Enhancing Clinical Trial Success: CDE’s New Adaptive Design Framework Opens for Comment
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The newly proposed guidelines are designed to be applicable across a spectrum of confirmatory clinical studies, encompassing chemical drugs, biological products, and traditional Chinese medicine (TCM). They also hold significant value for exploratory research endeavors. Adopting an adaptive design should be predicated on considerations of rationality, integrity, and feasibility. The…
