NMPA
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China NMPA (Order No. 28): Administrative Measures for Drugs Registration
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China NMPA (Order No.4): Administrative Measures for Drugs Importation
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China NMPA: Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017
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China’s NMPA Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)
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China’s NMPA Decree No. 101: Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices
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China’s NMPA Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices
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China’s NMPA Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices
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China’s NMPA Guideline No. 101: Registration of Rare Disease Control Medical Devices
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China’s NMPA Order No. 56 of 2019: Improving Related Issues Concerning Drug Evaluation, Approval and Supervision (DMF for API, Pharmaceutical Packaging Materials and Excipient
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China’s NMPA” Guideline for Technical Review of Medical Device Software Registration
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China’s NMPA: Announcement on Record Filling of Medical Device Master Files
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China’s NMPA: Guideline for Clinical Trials of In Vitro Diagnostic Reagents (Draft)
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China’s NMPA: List of the First Batch of Rare Diseases
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NMPA Guideline: Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses in China
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NMPA Order No.82, 2020: the Issuance of Working Procedures for Review of Breakthrough Therapies in China
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