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Pharmaceutical Affairs Research

 The term "pharmaceutical affairs" refers to the manufacture, dispensation, evaluation, safekeeping, importation and sale (including presentation; the same shall apply hereinafter) of medicinal products and quasi-drugs, and other pharmaceutical technology related matters. The pharmaceutical research and development phase of getting a new product onto the market takes several years; therefore, it is important that the process is controlled efficiently from start to finish in order to satisfy regulatory requirements and allow a favorable evaluation of efficacy and safety in the shortest possible period. Throughout any step of this cycle, the drug regulatory affairs (DRA) specialist plays an significant role, from designing regulatory plans following the identification of a new chemical entity to coordinating post-marketing activities. This state of affairs will continue indefinitely, bypassing normal market self-correction mechanisms, due to more popular and generous prescription drug benefits and public-sector drug services which are mostly passive consumers. The pharmaceutical affairs administration shall be conducted in compliance with the provisions of this Act.  Any matter not stipulated in this Act shall be governed by the regulations of other relevant legislation. For matters which the Controlled Drug Management Act governs. Those regulations are applicable with purity.  

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