VP, Global Pharmacovigilance and Epidemiology
1. What are the important elements to consider when building the safety section in product labeling?
The product label is where pharmaceutical companies (Sponsors) communicate the information needed for the effective and safe use of the medicine. To build the safety sections of the label, the Sponsors consider pre-clinical studies, clinical studies, post-approval data, and mechanism of action to describe both on target and off target effects of the medicine. After assessing these sources of information, the Sponsor constructs the set of core safety information that will be included in product labels. Constructing product label content requires input from many expert groups within a Sponsor company.
Countries maintain different requirements for medicine labels; the differences may be mostly formatting, but there may also be unique content requirements. Also, the threshold for including safety information in product label may differ among local health authorities.
2. What role does the product label play in risk management?
Risk identification is the first step in risk management. Once risks have been identified, the product label serves as the cornerstone for communication of identified risks. Labels can be complicated to read, even for health care providers. Communication materials beyond the product label are based on the safety and risk content included in the product label.
3. What are some of the challenges in building the safety section of product labels?
Constructing product label content requires input from many expert groups within a Sponsor company; experts in building product labels can facilitate this process, along with scientific subject matter experts, Regulatory affairs, pharmacovigilance and others. The frequency for introducing safety labeling updates is challenging, given that the creation of new labels generally require local regulatory approval for updates and must be closely coordinated with product manufacturing.