Aggregate Reporting in China
Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report –
Requirement in China
Periodic safety update report (PSUR) provides a periodic and comprehensiveassessment of the
worldwide safety data of a marketed drug. Over-time itwas recognized that the risk of the marketed drug should be
assessed in the light of its benefits and change in the risk estimate overtime. Consequently, the report name was
changed to Periodic Benefit-Risk Evaluation Report (PBRER).
According to China GVP,
Chapter V – Risk Identification and Assessment |
Section 4 – Periodic
Safety Report
Article 79 The periodic safety update report shall be based on the work carried out by the holders
during the reporting period. A comprehensive and in-depth review, summary and analysis of the collected safety
information shall be conducted, and the format and content shall meet the requirements of “Guidance for Writing
Periodic Safety Update Reports of Drugs”.
Article 80 For innovative drugs and improved new drugs a periodic safety update report shall be
submitted every 1 year from the date of obtaining the approval documents until the first re- registration, and then
every 5 years. For other types of drugs, the periodic safety update report shall generally be submitted every 5
years from the date of obtaining the approval documents. If the drug regulatory authority or the adverse drug
reaction monitoring agency requires otherwise, submission shall be made in accordance with the requirements.
Article 81 The data summarization time of the periodic safety update report starts from the date
when the drug approval document is first obtained or starts from the first approval date for marketing of the drug
around the world (i.e., the International Birth Day (IBD). Integrity and continuity should be maintained during the
periodic safety update report data coverage period).
Article 82 Periodic safety update reports shall be submitted through the National Adverse Drug
Reaction Monitoring System after approval by the pharmacovigilance responsible person.
Article 83 The holders shall deal with and respond to the review opinions on the periodic safety
update reports in a timely manner. For analysis and assessment requirements for specific safety issues, in addition
to separate submission as required by the drug regulatory authority or the adverse drug reaction monitoring agency,
it should also be analyzed and evaluated in the next periodic safety update report.
Article 84 The holders may submit a periodic benefit-risk assessment
report instead of a periodic safety update report. The writing format and submission requirements shall comply with
the relevant guidelines of the International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceutical for Human Use. Other requirements are the same as those for periodic safety update reports.
Article 85 The risk assessment in the periodic safety update report shall be based on all uses of
the drug.When carrying out a benefit-risk assessment, the assessment of effectiveness shall include data from
clinical trials and data obtained during actual use for the approved indication. The comprehensive benefit-risk
assessment should be based on the approved indications, combined with the risks in the actual use of the drug.
Article 86 Unless otherwise required by the drug regulatory authority, periodic safety update
reports do not need to be submitted for the following drugs or products managed as drugs: raw materials, in vitro
diagnostic reagents, Traditional Chinese medicinal materials, and Traditional Chinese medicine decoction pieces.
According to NMPA Announcement on the application of the ICH – E2C(R2): PBRER2, MAH can submit PBRER following the
ICH guidelines.
Reference:
1. China Good Pharmacovigilance Practice Announcement of the NMPA on the Publication of China Good
Pharmacovigilance Practice (No. 65 of 2021)
2. NMPA Announcement on the application of the ICH Guidelines, E2C(R2): PBRER (No. [2020]86)
Official FAQ related to PSUR in China
Which products are not required to submit a PSUR?
For APIs, excipients and in-vitro diagnostic reagents that are subject to the approval number, PSURs do not need
to be submitted.
For Chinese herbal medicines, Chinese herbal drinks and imported Chinese herbal medicines that are subject to
approval number control, it is not required to submit PSUR. For products that are manufactured by domestic
pharmaceutical manufacturers entrusted from abroad (e.g. certified by EU/FDA and other relevant
countries/regions, in compliance with the laws and regulations of the commissioning country) but have not
obtained the approval documents from China, it is not required to submit PSUR.
How should an overseas pharmaceutical manufacturer of an imported drug, which does not have
a drug
manufacturer in China but has an office or an agency appointed by it in China and a general agent for its
products in China, submit a PSUR?
The overseas pharmaceutical manufacturer of the drug should designate its office (or agent)
or general agent in China as the safety representative of the drug in China, to fulfil the responsibility of
reporting adverse drug reactions and submitting PSURs for the drug. After obtaining the authorisation from
the overseas pharmaceutical manufacturer, the representative office (or agency) or general agent in the
country will register with the Adverse Drug Reaction Monitoring Platform through the provincial centre where
the safety representative is located and then submit the PSUR.
Can a marketing authorisation holder use a Periodic Benefit-Risk Evaluation Report
(PBRER) to be submitted instead of a PSUR? What are the specific requirements if a PBRER is submitted?
Yes. If a PBRER is submitted, the format and timeline for submission apply to the ICH E2C (R2): Periodic
Benefit-Risk Evaluation Report (PBRER), i.e. PBRERs with a reporting period of 1 year or less should be
submitted within 70 days of the Data Lock Point (DLP) and within 90 days for those with a reporting period of 1
year or more. The guidelines and their questions and answers are available in the ICH section of the Centre for
Drug Evaluation website. Other questions can be found in the Guidelines for Writing Periodic Safety Update
Reports (PBRERs) and Frequently Asked Questions and Answers (Q&A).
The PBRER for imported medicines should be translated into Chinese and submitted together
with the original English PBRER, except for the annexes to the PBRER.
Fore more questions please leave your contact emails and we will provide you the Translated
version.
Reference:1. PSUR Frequent Question Answered (Q&A) answered 1 – 5
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