Case Reporting (ICSR Reporting)

According to the Provision for Adverse Drug Reaction Reporting and Monitoring (Order No.81 of the Ministry of Health), for Serious adverse drug reactions (including those collected by the spontaneous reporting system, those found in post-marketing clinical studies and those reported in the literature) occurring overseas for both imported and domestic drugs shall be reported to the National Adverse Drug Reaction Monitoring Centre (NADRMC) within 30 days from the date of notification. If the National Adverse Drug Reaction Monitoring Centre requires the original report and related information, the MAH shall submit it within 5 days.
Should you have any queries or seeking for consultation, please contact us via online chat or email.

Responsible Person for Pharmacovigilance (RPPV) in China

According to China GVP,
Article 24 The pharmacovigilance responsible person shall be in certain managerial positions, have a medical, pharmaceutical, epidemiology or relevant professional background with a bachelor degree and above or with a professional technical title of mid-at level and above, have an experience in pharmacovigilance-related work for more than 3 years, be familiar with China pharmacovigilance-related laws, regulations and technical guidelines, and have the knowledge and skills to manage pharmacovigilance work.
The pharmacovigilance responsible person shall be registered in the National Adverse Drug Reaction Monitoring System. If the relevant information is changed, the pharmacovigilance responsible person shall complete the update within 30 days from the date of the change.
Per China GVP Article 25, The pharmacovigilance responsible person is responsible for the operation and continuous improvement of the pharmacovigilance system, ensuring that the pharmacovigilance system meets the requirements of relevant laws, regulations, and this practice. The main responsibilities of this person include:
  1. To ensure compliance of adverse drug reactions monitoring and reporting;
  2. To oversight the identification, assessment and control of drug safety risks and ensure the effective implementation of risk control measures;
  3. To be responsible for the management of drug safety information communication and ensure timely and effective communication;
  4. To ensure smooth communication channels within the holders and with the drug regulatory authorities and the drug adverse reaction monitoring authorities;
  5. To be responsible for the review or sign-off of important pharmacovigilance documents.

In China, it’s called Responsible Person for Pharmacovigilance, which equals to QPPV. There is no specific requirement that only persons based in China can take the role of RPPV. But practically speaking, it is recommended to assign a person based in China to be local RPPV and keep contact available always so that authorities can reach the RPPV when necessary.

According to NMPA experts, it is not suggested to assign department managers, like PV or QA department, to be RPPV/QPPV because it’s required that the lead of PV shall have enough power to control PV activities and make decision in the company, like vice president. However, every company may have different situation to appoint the RPPV, but the key is the continuous training on the appointed person and RPPV is not just a role with title.



  1. China Good Pharmacovigilance Practice (GVP)

Announcement of the NMPA on the Publication of China Good Pharmacovigilance Practice (No. 65 of 2021)

Pharmacovigilance Inspection

China National Medical Products Administration (NMPA) is the leader who designate or set up the inspection institutions and assign inspectors to support local MPAs. With practical assistance of provincial MPA, they build inspector information platform together and then assign inspection team to actually conduct the on-site inspection in pharma companies. The lower tiers of MPA can apply inspector supports from the  higher authority.


The inspection team is consisted of inspectors from centers for drug control/testing, evaluation for approval, reevaluation, and ADR monitoring of national or local authorities. If there are any unlawful cases, then the legislative affairs office may be involved in and assist with the case handling.

Pharmacovigilance Safety Update Report (PSUR)

Per the Periodic Safety Update Reports Writing Guidelines1, the data for the Periodic Safety Update Report shall be summarised from the date of obtaining the drug approval document and shall be reported within 60 days of the data cut-off date. It is possible to submit a Periodic Safety Update Report starting from the international date of birth, but if the data cut-off date for the above-mentioned report is earlier than the cut-off date required in China, the data for this period should be supplemented and analysed.



  1. Guidance for Writing Periodic Safety Update Reports of Drugs

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)

Yes, MAH can use PBRER to replace PSUR. According to the announcement (NMPA No. 2020/86) released in July 2020, PBRER can replace PSUR, and the format and submission deadline shall follow ICH E2C (R2) Periodic Benefits-Risks Evaluation Report, which means PBRER with reporting period no more than one year shall be submitted within 70 days since DLP and PBRER with reporting period more than one year shall be submitted within 90 days since DLP.

Except for Line Listings and Summary Tabulations, all the other parts of PSUR shall be translated into Chinese and submitted with CCDS (Company Core Data Sheet) and original English version of PSUR.

Usually globally speaking, it starts from IBD, but if no information about IBD then CBD (approval date in China). If you miss the deadline of PSUR submission, the National ADR Monitoring System will still accept the submission but it does not mean the report passes.

Pharmacovigilance System Master File (PSMF)

Since the design of China PSMF is referencing EMA PSMF template, there is plenty of similarity in terms of structures of the Master File. it is feasible to convert the required elements into the Chinese version of PSMF suitable for China Regulatory Authorities. Contact us for our PV expert for PSMF conversion consultation.

Drug Safety Committee (DSC)

It depends. Generally the Drug Safety Committee concerns the drug safety globally from an overall point of view, but some markets may have different features and requirements. Furthermore, according to article 20 of GVP, the DSC is responsible for significant risk’s judgement & determination, significant or emergency events’ solution, risk control decision-making and other important events related with pharmacovigilance. Significant events are normally very urgent and it is required to respond immediately accordingly. But HQ Safety Committee may not even have enough time to respond for emergencies. So, it would be better to have local Safety Committee. However, if the HQ can make sure that they can respond timely and the SOP is compliant with China requirement, it’s also feasible.

Risk Management Plan (RMP)

Not all kinds of drugs are mandatory to create a RMP or PV Plan according to regulations. It is required for those marketed drugs found with significant risks according to risk assessment result and to keep the plan updated.

The PV Plan can be used as RMP and vise versa. For instance, if you already have a pre-marketing RMP, you can adjust it into a PV Plan or a post-marketing RMP accordingly.

Currently the regulatory requirement for PVP is included in the Clinical Risk Management Plan Writing Guideline document.

Safety Database in China

In China, it is mandatory for pharmaceutical companies to establish a safety database to collect and manage adverse drug reaction (ADR) reports as per the China GVP1 and ADR Reporting Guideline2 released by the National Medical Products Administration (NMPA).

Yes, outsourcing the safety database function to a third-party service provider is allowed in China, but the pharmaceutical company must ensure that the provider has adequate experience, expertise, and a robust quality management system.



  1. China Good Pharmacovigilance Practice (GVP)

Announcement of the NMPA on the Publication of China Good Pharmacovigilance Practice (No. 65 of 2021)

  1. Guidelines for the Collection and Reporting of Individual Adverse Drug Reactions

Announcement by the NMPA on the Issuance of Guidelines for the Collection and Reporting of Individual Adverse Drug Reactions (No. [2018] 131)

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