On 20 Jun 2022, the TITCK published the guidelines to Good Pharmacovigilance (IFU) Module X and Module Xi – pre marketing Benefit/Risk assessment and Post marketing benefit/Risk assessment respectively.
New Updates:
Module X: Pre-marketing benefit/risk assessment Guideline
- The acceptable benefits and risks should be briefly summarized along with the background of the disease, the course of treatment (eg, life-threatening versus (etc.) self-resolving disease with or without specific therapy, availability of different treatments) and the therapeutic indication.
- In the evaluation, it is important to identify the key findings and main evidence and uncertainties rather than the technical details of testing and research.
- Secondly, the important benefits and risks should be compared with each other in the specific therapeutic context, and the principles, relationships between data and outcomes and unresolved issues about the benefit/risk balance must be explained.
- The assessors must be objective and clear regarding the evidence used to support the conclusions.
- The assessment should identify benefits as well as unresolved issues and uncertainties and their implications for the balance assessment. Only significant results and issues that have an impact on the benefit/risk balance should be disclosed. In addition, unresolved issues or uncertainties should be identified and their impact on the balance assessment clearly stated.
- In addition, information such as important risks, probability of their occurrence, severity and the period of adverse events should be included.
- The benefit/risk balance should be evaluated to compare the benefits and risks described in the evaluation with alternative treatments or interventions and whether the benefit/risk balance is positive in the specified target population(s). The amount of evidence available on the benefit/risk balance, the perspectives of different stakeholders such as patients and physicians and other factors regarding the benefit/risk balance must be clarified.
Module XI — Post-marketing Benefit/Risk Assessment Guideline
- The guideline summarizes the way that the information the TITCK generally requests from the marketing authorization holders as part of the benefit/risk assessment should be arranged. However, the TITCK can still make additional information requests to the marketing authorization holders.
- The relevant marketing authorization holders are only responsible for providing evidence of the benefit/risk assessment for their medicine. (For example, if the agency is assessing the benefit/risk of a broader group of drugs with the same active substances, each marketing authorization holder will be subject to the same requirements for their own medicines)
- In the post-marketing benefit/risk assessment, the use of the medicine, previous safety interventions, diseases for which it is indicated, background information, information such as the relevant legislation and registration dates, current risk minimization strategies, exposure estimations, information on diseases and conditions specific to Turkey and other treatment alternatives should be included.
- In addition, benefits and risks should be characterized separately and discussed comparatively and the benefit/risk profile should be evaluated. In this context, the main benefits and key risks of the medicine should be summarized and the quality of the evidence should be discussed.
References:
** Note: Used machine translated document for drafting this article
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