purpose

The purpose of this evaluation; To evaluate the cumulative information about risks and benefits, to analyze the benefit/risk balance in a comprehensive, concise and critical manner, taking into account all the information that emerges for the first time or becomes meaningful with the new information obtained.

​

Scope  

The benefit/risk balance analysis performed during the drug's reporting interval includes assessments of previously known safety, efficacy during clinical trials, and available efficacy information.

​

Application

Periodic benefit/risk assessment report (PBRER) refers to the report containing the evaluation of the benefit/risk balance of the drug, which we prepare in a certain format at predetermined times in the post-authorization period.  The report, which is defined as the Periodic Security Update Report (PGGR) in the EU, is called PBRER in our country.

 

Periodic benefit-risk assessment should be prepared in accordance with the following timeline:

 

• For PBRERs covering intervals up to 12 months, within 70 calendar days from the data lock point (including full 12-month intervals).

• Within 90 calendar days from the data lock point for PBRERs covering intervals exceeding 12 months.

 

The main topics that PBRER focuses on are summary information, scientific safety assessment and integrated benefit/risk assessment, and detailed lists of individual cases and case statements should be included. It is extremely important in terms of providing information on whether or not a change has occurred in the balance, and in this respect, it is related to the risk management plan.

We regularly and periodically evaluate the safety of our medicines.