Regulatory Requirements and Registration Procedure for Generic Drugs in USA

Abstract

A generic drug is more efficient, safe and low-cost alternative of the innovator or branded drug in the market. They are similar to the branded drugs in strength, quality, purity and their safety and efficacy have been proven since they have been in the market for a longer time. The availability of generic medicine should be made easier throughout the world. The US has one of the most demanding regulatory authorities and registration of drug products will be a long process if not complied with the US Food and Drug Administration (USFDA) guidelines. Abbreviated New Drug Application is the application to be filed for registering generic drug. One of the main tasks of the regulatory authorities is to ensure that the drug development, manufacture and testing has been carried out according to the regulations and guidelines and that everything is documented accordingly. International Conference on Harmonization (ICH) established a harmonized format for submission of application on registering drug products. This paper approaches the registration requirements of generic drugs in the form a dossier for market authorization in the US.

Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

“…As mentioned earlier, bio-equivalence of the generic product with reference listed drug (RLD) is the one of the prime criteria for development of generic product [8]. Reference product selection for US market can be easily done by literature search at US FDA database and can be easily identified by their NDA number [5].…”

“…Increase in batch size or scale-up are obtained by using larger, high-speed machinery that may necessitate co-relation to the process parameters determined using small scale equipment. Then the end goods must meet all predefined specifications, and the products from scaled-up batches must be physically and chemically identical, notably the dissolving profile [9]. Large scale batches or scale-up batches using modern technology has become essential in minimizing manufacturing costs in today's competitive market [15].…”

“…The generic product is analyzed at monthly intervals mainly potency, dissolution, related substances. Stability of RLD should be carried as well for information only, mainly to assess the related substances [9]. This is important for the formulation scientist to validate and characterize the critical parameters and set specification during the initial formulation process.…”

“…This happens especially for low dose drug with low average weight. Batch size, stability protocol of the developed product depends on the market being targeted [9]. The following Table 1 shows requirement of different regulatory bodies [6].…”

“…Regulatory agencies ensure the safety, efficacy, and quality of all generic products, as well as the production and distribu-Journal of Biosciences and Medicines tion processes. The regulatory authority's primary aim is to ensure that pharmaceutical goods are developed in accordance with the country's regulatory requirements, and generic companies aim to meet those requirements [9].…”