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China Tightens Medical Device Quality Oversight: 2025 Inspection Plan Unveiled
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China’s National Medical Products Administration (NMPA) has released its 2025 medical device inspection plan, outlining stricter quality oversight and compliance requirements. The new guidelines aim to enhance product safety, enforce regulatory standards, and streamline market access for domestic and international manufacturers. Key Policy Highlights Impact on Medical Device Manufacturers Reinspection…
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China Unveils 2025 Medical Device Inspection Strategy to Tighten Quality Control
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China’s National Medical Products Administration (NMPA) convened a pivotal conference in Chengdu on March 24 to outline its 2025 medical device inspection agenda. The meeting highlighted achievements from 2024, including enhanced product quality and public safety, while emphasizing stricter compliance frameworks to address evolving industry risks. 2024 Progress and 2025…
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China’s 2025 Pharmacopoeia Edition Approved, Set for October 1 Implementation
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The Pharmacopoeia of the People’s Republic of China (2025 Edition), released by the National Medical Products Administration and National Health Commission, has been approved by the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee. The new edition is scheduled for implementation on October 1, 2025. Regulatory RequirementsFrom the…
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NMPA Updates Rules on Domestic Production of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification on further adjusting and optimizing matters relating to the domestic production of imported medical devices by companies within China, effective immediately. This update aims to streamline the regulatory process and support the localization of production for imported medical devices. Key…
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Acotec Scientific’s Vericor Catheter Wins NMPA Approval for Peripheral Vascular Surgery
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that its peripheral disposable support catheter Vericor has received marketing approval from the National Medical Products Administration (NMPA). The device is designed for peripheral vascular surgery, aiding in lesion access and treatment. Product ProfileSupport catheters are essential tools in peripheral vascular procedures,…
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NMPA’s New Guidelines for Drug Registration Review
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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…
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NMPA Seeks Public Feedback on Export Drug Manufacturing Rules
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An In – Depth Look at the New Draft Proposal for the Administration and Management of Export Drug Production in ChinaThe National Medical Products Administration (NMPA) has released a new notification soliciting public feedback on a set of rules related to the administration and management of export drug manufacturing. This…
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NMPA Implements Regulatory Reforms for Drug and Medical Device Industries
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The National Medical Products Administration (NMPA) has released a notification regarding the implementation of the “Decision of the State Council on Amending and Abolishing Some Administrative Regulations.” This move is part of a broader effort to streamline regulatory processes and enhance market vitality in the medical sector. Key Reforms and…
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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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NMPA Releases 88th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 88th batch of reference drugs for the Generic Quality Consistency Evaluation (GQCE) work. This update is part of the ongoing efforts to ensure the quality and efficacy of generic drugs in the Chinese market. Details of the ReleaseThe latest batch includes…
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NMPA Releases 87th Batch of Reference Drugs for Generic Quality Consistency
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The National Medical Products Administration (NMPA) has released the 87th batch of reference drugs for generic quality consistency evaluation (GQCE) work, furthering its efforts to ensure the quality and consistency of generic medications in the market. Expansion of Reference Drug SpecificationsThis latest batch encompasses 38 new specifications for reference drugs,…
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NMPA Proposes Draft for Simplified Registration of Traditional Chinese Medicines from Hong Kong and Macao
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The National Medical Products Administration (NMPA) has issued the “Notification on Simplifying the Registration and Approval of Traditional Oral Traditional Chinese Patent Medicines Listed in Hong Kong and Macao in mainland China (draft proposal)”, and is soliciting public feedback until December 24, 2024. This move signifies a step towards streamlining…
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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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China’s NHC Launches Pilot Plan to Expand Wholly Foreign-Owned Hospital Sector
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The National Health Commission (NHC) has released the “Pilot Work Plan for Expanding the Wholly Foreign-Owned Hospital Sector,” supported by the Ministry of Commerce (MOC), National Administration of Traditional Chinese Medicine, and National Bureau of Disease Control and Prevention. This policy aims to set specific requirements for the operation of…
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NMPA Drafts Medical Representative Management Measures, Seeks Public Input
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The National Medical Products Administration (NMPA) has released the “Medical Representative Management Measures (draft proposal)”, which has been developed in consultation with the Ministry of Public Security, National Healthcare Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and National Bureau of Disease…
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Chinese Pharmacopoeia Commission Approves Draft for ChP 2025 Edition
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On December 27, the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee concluded with the approval of the draft for the 2025 edition of the Chinese Pharmacopoeia (ChP 2025 Edition). The approval paves the way for the imminent implementation of the new edition. Enhancements in Scientificity and StandardizationThe…
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NMPA and Local Governments Streamline Drug Approval Processes in China
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The National Medical Products Administration (NMPA) has released a notification regarding the pilot work for optimizing the review and approval procedures of supplementary drug applications, a program introduced in February this year. The initiative aims to enhance the efficiency of drug application reviews and has designated Beijing, Tianjin, Hebei province,…
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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…
