المملكة: exemption "Junus" and"Similar biological" From mandatory drug economics studies
The Food and Drug General Authority offered the updated version of the “Evaluation of Drug Economics Studies” through a “poll” platform, in a move aimed at involving specialists and interested in Review the updates proposed, before they are officially approved within the regulatory system for registration and pricing of medicines in the Kingdom." target ="_Blank"> Types of economic studies that must be presented within the files of drug registration, in addition to defining the requirements and regulatory standards for these studies, in order to enhance the accuracy and effectiveness of registration and pricing decisions, and raises the efficiency of drug spending." target ="_Blank"> Amending the requirements associated with the provision of evaluation economic studies «ES), as it stipulated the necessity of presenting at least one study, which is the most appropriate for the nature of the drug product in place of application, which reflects a more elastic organizational orientation and associated with the scientific context of the product. Geniilers chemical products, similar biological products «BIOSIMILARS), which means that providing economic studies has become only mandatory for some types of products and not others, according to the classification. Prepared by the commission, provided that this request is submitted at least four months before the official application date, ensuring the organization of the process and facilitating the procedures for the exception more accurately and planning. Organizational enhances the efficiency of the drug market in the Kingdom.
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