The purpose of regulatory submission and review is to obtain approval from regulatory authorities for the marketing and sale of pharmaceutical products. ​ Regulatory submission refers to the process of preparing and submitting comprehensive documentation to regulatory authorities that provides evidence of the safety, efficacy, and quality of the product. ​ The regulatory review process…
Fixed-dose combination (FDC) drug products present unique challenges in biowaiver assessments, as they involve multiple active pharmaceutical ingredients (APIs) with different physicochemical properties and release characteristics. Regulatory guidelines (USFDA, EMA, WHO) provide biowaiver provisions, but their applicability depends on several factors, such as API solubility, permeability, formulation type, and release mechanisms. Key Considerations for Biowaivers…
Regulatory compliance is a critical aspect of pharmaceutical product lifecycle management. When making post-approval changes in topical formulations, selecting the appropriate FDA submission pathway—CBE-30 (Changes Being Effected in 30 Days) or PAS (Prior Approval Supplement)—ensures compliance while maintaining business continuity. Understanding when to file CBE-30 vs. PAS can significantly impact timelines, regulatory approvals, and market…
Changes in equipment used for manufacturing a product can have different implications depending on the market. Regulatory authorities assess these changes based on their potential impact on product quality, safety, and efficacy. Below is a comparative view of how major markets handle equipment changes: USFDA Risk-Based Approach: Major Change (Prior Approval Supplement – PAS): If…
When changing the grade of an excipient for different markets the regulatory approach depends on whether the change impacts safety, quality, or efficacy of the drug product. Here’s how to address it for key regulatory agencies: USFDA Filing Type: Documentation: MHRA & EMA Variation Classification: Documentation: MENA Region (Saudi FDA, UAE, Egypt, etc.) Regulatory Approach:…
Filing a Paragraph IV (Para IV) certification for a generic drug requires either proving non-infringement or challenging the validity of the patent covering the reference listed drug (RLD). A deep understanding of independent and dependent claims is crucial to designing around a patent. Understanding Patent Claims Patent claims define the legal protection granted to an…
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