Submission of PBRER upon HSA's request

The Periodic Benefit-Risk Evaluation Report (PBRER) provides a comprehensive, concise and critical analysis of new or emerging information on the product’s benefit-risk profile in its approved indications.

HSA may request for the routine submission of PBRER for specific products (see How to submit). The registrant will be informed accordingly through the product’s registration conditions.

The registrant must submit the PBRER:

a) at intervals of 6 months commencing from the date of registration of the product for an initial period of 2 years; and

b) annually, for the next 3 years.

The first PBRER submitted should include data from the date of local product registration. For example, if the product was approved locally in July and the data lock period of the latest available PBRER was from January to June, this PBRER does not need to be submitted. Instead, the next PBRER with a data lock period of July to December will be considered as the first PBRER submission to fulfil the post-approval conditions for the product.

Each subsequent PBRER should cover the period since the last updated report and should be submitted within 70 days (for PBRER covering up to 12 months) or 90 days (for PBRER covering more than 12 months) from the data lock point.

After the initial 5 years of registration approval, HSA may request for PBRER to be continued to be submitted if there are reasons to continue the safety monitoring of the product in the market.

How to submit

• Therapeutic products – Online form, or eCTD (Section 5.3.6 Reports of Postmarketing Experience, Submission Type - PV-PBRER/RMP Reports)

• CTGTP – SHARE (Fulfilment of Approval Condition)

Please indicate the purpose of the submission. For example, “PBRER submission for [Product Name], Data lock period DD-MM-YYYY to DD-MM-YYYY”