Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

Abstract

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.