In the section describing pharmacodynamic and pharmacokineti…
In the section describing pharmacodynamic and pharmacokinetic characteristics, the Professional Information (PI) of a recently registered generic medicine repeatedly refers to the medicine using its proprietary (brand) name rather than the approved International Non-proprietary Name (INN). In a separate section discussing therapeutic performance, the PI includes statements directly comparing the product to a named competitor medicine, asserting that the company’s product demonstrates faster onset of action and improved clinical outcomes. Additionally, the PI uses the US Adopted Name (USAN) “acetaminophen” inconsistently, without providing the corresponding INN nomenclature. Based on standard requirements for Professional Information content, which of the following best reflects the regulatory assessment?
Read DetailsDuring the compilation of the proposed PI for a new applicat…
During the compilation of the proposed PI for a new application for registration of a generic product, you have obtained a copy of the SmPC as approved for the innovator by the MHRA in the UK. In comparing the information, you find three differences from the SA approved PI, apart from the country-specific information, namelyan additional, new indication for use of the product,a warning which is indicated as a contra-indication in the SA document,additional adverse events resulting from post-marketing studies.You also note that the date of the UK SmPC is later than that of the SA document.Explain how you will address these differences in your proposed document, giving your reasons, and supply the relevant regulatory reference/s
Read DetailsThe Sponsor receives notification from a clinical investigat…
The Sponsor receives notification from a clinical investigator of a fatal adverse event suspected to be related to one of its authorised medicines. The event is not consistent with the known safety profile described in the current product information and is therefore considered unexpected. According to pharmacovigilance reporting requirements, what is the appropriate timeframe for submitting this report to the relevant regulatory authority from the date of first awareness?
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