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A large number of dosage forms, product presentations, and product strengths results in a large number of labeling records, which must be maintained and kept synchronized.The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have implemented a set of rules for electronic submission of labeling content. Whereas, the EMA requires companies to submit product information documents in a format that is QRD-compliant.Companies, which are in the regulated life sciences industries, should develop and implement systems and processes to ensure compliance with these standards for their global labeling content.

Indications were considered similar when they were for the same general intended use and there were only differences in wording or organization of the information. 536/2014 Annex VI defines the clinical labeling requirements for both investigational medicinal products (IMPs) and auxiliary medicinal products (AMPs) and the labeling requirements differ for each. Y�`�JK;$�VT �2t�@]���4�Q��O���?�F�;`V�r���t�D�k&� oMX�[30^�Ҍ@� � �%w� endstream endobj 61 0 obj <> endobj 62 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Type/Page>> endobj 63 0 obj <> endobj 64 0 obj <> endobj 65 0 obj <>stream

We next examined applications for which the two agencies had differing outcomes in terms of approval and indication, assessing the scientific and regulatory reasons underlying these differences.There were 126 and 125 new drug marketing applications for a new active substance, a new chemical entity (NCE), or a therapeutic biologic product submitted to the FDA and the EMA, respectively, and which had an outcome in the period 2014–2016. Also, this webinar is important for you if you are responsible for ensuring compliance with labeling requirements for your company in any way.Webinar Compliance reserves the right to cancel or reschedule any Webinar/event due to inevitable reasons such as insufficient registrations or circumstances beyond its control. 0000008175 00000 n 0000001136 00000 n For the FDA, the type of marketing approval refers to standard approval or accelerated approvalWe also assessed for differences in approved indications across agencies, defining indication as the medical disease or condition and population for which use of the drug is approved. As per FDA, the companies are required to submit XML labeling content in Structured Product Labeling (SPL) format. Pharmaceutical companies should manage the process of designing and creating product labels meeting regulatory requirements. This is because our study objective was to determine whether the agencies varied in their conclusions about an application, and such an assessment can only be made when the conclusions are based on the same information.We thank Dr. Youness Ameur of the European Medicines Agency for his contributions to the collection of data for the research reported in this article.This work was funded by US Food and Drug Administration and the European Medicines Agency.The authors declared no competing interests for this work.M.K., Z.H., J.L., and S.L.K. Indications for which the two researchers were uncertain or had divergent interpretations were then independently evaluated by the other researchers using the same criteria for notable differences. All the attendees will be notified about the cancellation of the event, 24 hours prior to the start time of the Webinar event.The cancelled Webinar, could be rescheduled and a New Date would be promptly intimated to the attendees.​Individual attendees can cancel their event for any specific reason. As a window to the impact of these activities we compared the agencies’ decisions on drug marketing applications. Eight drugs had differences in both indication and type of marketing authorization.

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