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Abstract

Background: Every country has its basic legislation concerning to protect public health and ensure the availability of high quality, safe, and effective medicinal products. Pharmaceutical products in Europe are tightly regulated to protect public safety and promote European Union (EU) patients access to novel pharmaceutical goods. [1] The European Medicines Agency (EMA) integrates the Member States current research tools for the evaluation, monitoring, and pharmacovigilance of pharmaceutical products for medical and veterinary usage in the EU. Objectives: The objective of this study is to depict the initial registration requirements for modified release dosage forms in the Europe and to minimize the error in compiling the dossier by understanding the critical aspects involved in the marketing application for modified release dosage forms. Discussion: The EMA uses different marketing authorization paths for authorizing a drug to be marketed in different countries in Europe, and all the procedures require different types of registration process. Pharmaceutical dosage forms can be produced in which the pace and/or position of release of the active substance(s) in contrast with traditional release formulations has been changed in any way. These modifications can have a variety of purposes, such as sustaining long-term medicinal efficacy, minimizing adverse consequences, shielding the active substance from low pH degradation, directing the active substance to a predefined gastrointestinal tract section for local care, or directing the release of active substances at established time points.

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	JPR Solutions

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