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China Pharmacovigilance (PV)
Regulations & Standards
Regulations & Standards
China Pharmacovigilance (PV) Guidelines
| Category | Regulations | Summary | Link |
|---|---|---|---|
| China GVP | China Good Pharmacovigilance Practice | To regulate the full life cycle of medicinal products of pharmacovigilance activities |
China Good Pharmacovigilance Practice (GVP) [en_free]Send download link to: |
| China PSMF | Pharmacovigilance System Master File (PSMF) Writing Guidelines in China | Guidance document that proposes general requirements for drafting the PSMF |
Pharmacovigilance System Master File (PSMF) Writing Guidelines-ENSend download link to: |
| China ICSR | CFDA Announcement on the Application of Secondary Guidelines of International Conference on Harmonization Technical Requirement for Registration of Pharmaceuticals for Human Use (No.10, 2018) | Application of several ICH guidelines:
|
CFDA Announcement on the Application of Secondary Guidelines of ICH (No.10,2018)-ENSend download link to: |
| Decree of the Ministry of Health of the People’s Republic of China No.81, Provisions for Adverse Drug Reaction Reporting and Monitoring | To strengthen the post-marketing supervision of drugs, standardise the reporting and monitoring of ADRs and control the risk of drugs in a timely and effective manner.
The Decree covers the responsibility of MAH on
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Decree of the Ministry of Health of the People Republic of China No.81 – Provisions for ADR Reporting and Monitoring-ENSend download link to: |
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| Announcement of National Medical Products Administration on Direct Reporting of Adverse Drug Reactions by Drug Marketing Authorization Holders (MAH) in China (No. [2018] 66) | To implement the main responsibility of ADR reporting by MAH for medicines |
Announcement of National Medical Products Administration on Direct Reporting of Adverse Drug Reactions by Drug Marketing Authorization Holders (No. [2018] 66)-ENSend download link to: |
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| Announcement by the NMPA on the Issuance of Guidelines for the Collection and Reporting of Individual Adverse Drug Reactions (No. [2018] 131) | Instruction specifics for ADR
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Announcement by the NMPA on the Issuance of Guidelines for the Collection and Reporting of Individual Adverse Drug Reactions (No. [2018] 131)-ENSend download link to: |
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| Regional Implementation Guide for Individual Case Safety Reports E2B (R3) | This guide applies to the submission of pre-marketing and post-marketing ICSR by the sender to the Chinese drug regulatory authorities. Compiled in accordance with the ICH E2B(R3) guideline document, the guideline describes the data element items, element coding rules, logical checking relationship between elements and transmission standards for electronic transmission of ICSR, to facilitate the sharing and exchange of information of individual safety reports among different organisations. |
Announcement of the National Food and Drug Administration (NFDA) on the Issuance of Guidance for Writing Periodic Safety Update Reports of Drugs (No. [2012] 264) – ENSend download link to: |
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| FAQ of Regional Implementation Guide for Individual Case Safety Reports E2B (R3) |
FAQ of Regional Implementation Guide for Individual Case Safety Reports E2B (R3)-ENSend download link to: |
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| China RMP | Announcement by the CDR of NMPA on the publication of the Guidelines for Writing Clinical Risk Management Plans (Interim) (No. 68 of 2021) | The Guideline is not legally enforceable, it is recommended that the applicant should refer to the template attached to the Guidelines to prepare a Clinical Risk Management Plan when submitting a NDA in China. After the drug is approved for marketing, MAHs shall form a “Pharmacovigilance Plan” and/or “Post-Marketing Risk Management Plan” based on the content of the “Clinical Risk Management Plan” template that this guideline provided. |
Announcement by the CDR of NMPA on the publication of Guidelines for Writing Clinical Risk Management Plans (Interim) (No. 68 of 2021)-ENSend download link to: |
| China DSUR | Announcement by the CDE of NMPA on the publication of the “Management Standard for Development Safety Update Reports” (Interim)” (No. 7 of 2020) | To standardise the writing and management of DSUR | Chinese Version Only. Contact to request for English translation. |
| Announcement of public consultation on the Chinese translation of the ICH-E2F: Development Safety Update Report | Chinese version of ICH-E2F | Chinese Version Only. Contact to request for English translation. | |
| Announcement by NMPA on the Application of 15 ICH Guidelines, including “E1: Exposure Levels in Populations: Assessing the Clinical Safety of Drugs for the Long-Term Treatment of Non-Life-Threatening Diseases” and others (No. [2019] 88) | E2F – Effective from publication date (12Nov2019)
E2E will be applicable for
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Chinese Version Only. Contact to request for English translation. | |
| China PSUR/PBRER | Announcement of the National Food and Drug Administration (NFDA) on the Issuance of Guidance for Writing Periodic Safety Update Reports of Drugs (No. [2012]264) | To standardise the writing and management of PSUR |
Announcement of the National Food and Drug Administration (NFDA) on the Issuance of Guidance for Writing Periodic Safety Update Reports of Drugs (No. [2012] 264) – ENSend download link to: |
| PSUR Frequent Question Answered (Q&A) answered 1 – 5 | Official FAQ of PSUR | FAQ 1-5 Click: 1 2 3 4 5 (Chinese only) | |
| NMPA Announcement on the application of the ICH Guidelines, E2C(R2): PBRER (No. [2020]86) | From 21Jul2020, MAH for medicines can submit PSUR by applying the E2C(R2): PBRER of the ICH Level 3 Guidelines.
MAH can submit PBRERs, or they can submit Aggregate Reports in accordance with
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Chinese Version Only. Contact to request for English translation. | |
| ICH “E2C(R2): Periodic Benefit-Risk Evaluation Report (PBRER) (Chinese translation draft for public consultation) | Chinese version of ICH-E2C | Chinese Version Only. Contact to request for English translation. | |
| China PVA | Announcement on the Publication of Guidelines for Writing Pharmacovigilance Agreements (Interim) | The guidance document to clarify and regulate the obligations and responsibilities of the holder and the entrusted party in the entrusted work of pharmacovigilance, and to ensure the effective monitoring, identification, assessment and control of post-marketing adverse drug reactions and other harmful reactions related to the use of medicines. This guideline is applicable to the holder for reference when signing the pharmacovigilance entrustment agreement. | Chinese Version Only. Contact to request for English translation. |
| China PV Audit / Inspection | Announcement by the NMPA on the Issuance of the Guidelines for Pharmacovigilance Inspections in China No. [2022] 17 | This guideline specified the inspection requirement for following aspects:
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Guide to China Pharmacovigilance (PV) AuditSend download link to: |
| MedDRA | Announcement on the publication of the MedDRA Coding Guidelines for Marketing Authorisation Holder | – | Chinese Version Only. Contact to request for English translation. |
| China Local Representative of Overseas MAH | Public consultation request for “Interim Provisions on the Administration of Local Representative for Overseas Marketing Authorisation Holder” by the General Department of the NMPA in China | – |
Pharmacovigilance System Master File (PSMF) Writing Guidelines-ENSend download link to: |
| Clinical Safety Reporting in China | Announcement of the publication of the Standards and Procedures for Expedited Reporting of Safety Data during Drug Clinical Trials | SOP for Clinical Expedited Reporting, drafted based E2A, E2B(R3) and M1. | Chinese Version Only. Contact to request for English translation. |
| Announcement by the CDE of NMPA on the publication of the Expedited Reporting of Safety Data during Drug Clinical Trials FAQ (version 2.0) | Official FAQ of Clinical Expedited Reporting regarding:
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Chinese Version Only. Contact to request for English translation. | |
| Announcement by the CDE of NMPA on the Publication of the Standard for Assessment and Management of Safety Information during Drug Clinical Trials (Interim) (No. [2020]5) | This guideline document covers following perspectives during clinical trials:
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Chinese Version Only. Contact to request for English translation. | |
| Announcement by the CDE of NMPA on the publication of the Guidelines for the Summary Analysis and Reporting of Safety Information during Drug Clinical Trials (Interim) (No. [2023] 16) | This guideline focuses on guiding sponsors to continuously evaluate and timely report information on Serious Adverse Event (SAE) and other potential serious safety risks during clinical trials of drugs related to registration and provides basic considerations for safety evaluation and safety reporting during clinical trials of drugs. | Chinese Version Only. Contact to request for English translation. | |
| Announcement of public consultation on the Chinese translation of ICH “E2A: Management of Clinical Safety Data: Definitions and Standards for Expedited Reporting | Chinese version of ICH: E2A | Chinese Version Only. Contact to request for English translation. | |
| China Literature Screening | Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim) | – |
Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim)-ENSend download link to: |
For any questions on China Pharmacovigilance (PV) requirements and regulations, you may message us on: info@accestra.com