CDSCO, US FDA conduct workshop on regulatory perspectives in design, execution of BA/BE studies for generic drugs

PharmaClick Bureau, Mumbai

The Central Drugs Standard Control Organization (CDSCO) and the USFDA have organized a technical workshop on regulatory perspectives in the design and execution of Bioavailability (BA) and bioequivalence (BE) studies for generic drugs.?

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The workshop aimed at improving industry stakeholder understanding of regulatory perspectives and expectations for data integrity and human subject protection in the process of evidence generation for generics and complex generics.

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India has about 650 or 25% of USFDA approved plants outside the US. The country is also home to the highest number of USFDA plants after the US.

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BA and BE studies are clinical trials that evaluate the rate and extent to which a drug is absorbed from a test formulation.?These studies are important for the early and late development of drug candidates.

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The workshop was held at FDA Bhawan New Delhi on September 13, 2024. The FDA team, led by Greg Smith, Country Director, US FDA INO. Dr.Ilun Murphy, Director, OGD, Dr. Sean Kassim, OSIS, Dr Roy, OB and others made presentations on the BA/BE requirements of generic drugs.

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The workshop also discussed regulatory inspection/compliance trends and regulatory expectations for the oversight and conduct of BA/BE?studies, including the use of emerging digital tools and solutions. It also deliberated on case?studies?and examples, observations of practices to better ensure adequate human subject protection, and improved data integrity. It also shed light on regulatory perspectives on evidence generation issues and considerations for complex generics.

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India exports 30% of the generic drugs used in the US. This workshop helped the Indian regulators to understand the current requirements of BA/BE data for approval of generic drugs in the USA, stated Chandrashekar Ranga, joint drugs controller, CDSCO.

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Pharma and medtech regulatory affairs experts have hailed CDSCO and USFDA for organizing a successful technical workshop on regulatory perspectives in the design and execution of BA/BE studies for generic drugs.

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Shivang Saxena, a regulatory affairs professional stated that this collaboration will definitely help Indian regulators to understand the current requirements of BA/BE data for approval of generic drugs in the USA. It's great to see such initiatives being taken to ensure the safety and efficacy of generic drugs.

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Snehendu Koner, Site Operations Lead (Clinical Trials) at Auriga Research, Site Identification & Site Selection Specialist, Study Feasibility & Start-up Manager, said “These equip Indian researchers to deliver higher-quality research that meets global standards, ultimately strengthening the country’s clinical research ecosystem.”

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By clarifying its regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of abbreviated new drug applications (ANDAs) submitted to the Agency for approval. At the same time, FDA is implementing initiatives to enhance its own review process efficiency to improve the speed and predictability of the generic drug review process while maintaining our rigorous scientific standards.

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The FDA has updated guidelines for amending ANDAs under ?????????? ?????? to enhance the review process for generic drug submissions, with goal dates based on submitted content.

The updated guidance, which replaces the July 2018 version, incorporates significant revisions based on public feedback from the 2022 docket.

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Appendix A now includes a revised list of major deficiencies, potentially extending review timelines, to address public input and ensure clarity. The guidance outlines that the assessment objectives are exclusively applicable to submissions that necessitate substantive review.

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The FDA is implementing GDUFA III to expedite the approval of safe, affordable, and effective generic medicines by reducing review cycles.