DDReg Pharma

DDReg Pharma

Searchable Databases for Bio-Equivalence Guidance

Product-specific bioequivalence guidelines are crucial to support the development of safe, efficacious, and high-quality generic products. They provide information to manufacturers on how they can demonstrate therapeutic equivalence of their products compared to the reference drugs. Adherence to these guidelines streamline the regulatory approval process while also ensuring confidence with respect to the interchangeability of generic drugs. Indeed, a clear and standardized framework for bioequivalence facilitates scientific evaluations which helps regulatory authorities in making informed decisions for the regulatory approval of generic products.

Regulatory authorities, like the US FDA and EMA, have been making efforts to ensure such guidelines are easily accessible by providing searchable databases. These databases serve as a comprehensive repository for product-specific bioequivalence guidelines and offer manufacturers a single platform through which they can access the required guidelines. The complexity and dynamic nature of generic product regulations that face constant updates and revisions lead to the need for these databases/repositories.

US FDA: Product-Specific Guidance for Generic Drug Development

The US FDA publishes product-specific guidances (PSG) to support ANDA approval & generic product availability. The PSGs are consistent with the US FDA’s Generic Drug User Fee Amendments Reauthorization of 2022 (GDUFA III) goals. The US FDA also assesses drug availability and accessibility, taking into account public health priorities such as public health emergencies and updates on drug safety & efficacy. Beyond these factors, the US FDA consistently reviews the progress and results of ongoing GDUFA research to verify the presence of ample and reliable data and evidence. This ongoing assessment aims to ensure that the PSG is developed in line with the FDA’s current scientific perspectives. It is important to note the US FDA’s requirement regarding data formats, different guidance documents specific electronic formats, subject matter, and scope of applicability for certain submissions. Electronic formats specified must be used for ANDA submissions.

EMA: Product-Specific Bioequivalence Guidance

The European Medicines Agency (EMA) also provides a single platform where it maintains and updates product-specific bioequivalence guidance documents. These provide information on standardized format & relevant study designs that would help in demonstrating bioequivalence. These product-specific guidance help applicants to meet the EU regulators’ expectations and requirements for generic applications across centralized, decentralized, mutual recognition, or national procedures. 

Access to appropriate PSGs is critical in facilitating timely drug development and for upholding rigorous safety, efficacy, and quality standards by demonstrating bioequivalence. These guidelines provide a structured framework for manufacturers and outline the US FDA & EMA’s requirements for establishing bioequivalence. Adherence to such guidelines is essential to navigate the regulatory process efficiently in order to expedite product approvals while also ensuring that generic products meet the standard for therapeutic equivalence.

For over 15 years, DDReg has supported its customers with end-to-end regulatory services for generic product development in line with the stringent requirements of the US FDA and EMA. Read more from our experts on Reforming ANDA Suitability Petitions.