China

Showing 1–16 of 29 results

Announcement on 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 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’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. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (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: Guideline on the Design of Clinical Trials for 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 DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production
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China’s NMPA Decree No. 83: Innovative Medical Device Special Approval Procedure
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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 Order No.82, 2020: the Issuance of Working Procedures for Review of Breakthrough Therapies
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China’s NMPA Technical Guidelines: Marketing Registration of OTC Chemical Drugs – July 2020
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China’s NMPA” Guideline for Technical Review of Medical Device Software Registration
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Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017

China NMPA (Order No. 28): Administrative Measures for Drugs Registration

China NMPA Order No.4: Administrative Measures for Drugs Importation

China’s NMPA Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)

China’s NMPA Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)

China’s NMPA Decree No. 101: Regulations for The Administration of Overseas Inspection of Pharmaceutical & Medical Devices

China’s NMPA Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices

China’s NMPA Decree No. 6: Guideline on the Design of Clinical Trials for Medical Devices

China’s NMPA Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices

China’s NMPA DECREE NO. 7 : Measures for Supervision and Administration of Medical Device Production

China’s NMPA Decree No. 83: Innovative Medical Device Special Approval Procedure

China’s NMPA Guideline No. 101: Registration of Rare Disease Control Medical Devices

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

China’s NMPA Order No.82, 2020: the Issuance of Working Procedures for Review of Breakthrough Therapies

China’s NMPA Technical Guidelines: Marketing Registration of OTC Chemical Drugs – July 2020

China’s NMPA” Guideline for Technical Review of Medical Device Software Registration

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