Pharma GMP News of the Week: 22-August-2021

Period: August 15, 2021 to August 21, 2021

FDA published revised draft guideline on “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry”

Date of publishing: August 20, 2021

As per the agency, the purpose of revised draft is to clarify the agency’s recommendations regarding BE information submitted in an ANDA submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.

The new revision updated a draft originally published in the month of December 2013.

Download draft guidance

Source: https://www.fda.gov

ICMRA released paper on Artificial intelligence in medicine regulation

Month of release: August 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.

AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are increasingly being applied across all stages of a medicine’s lifecycle: from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimisation. This range of applications brings with it regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of AI failures and the wider impact these would have on AI uptake in medicine development and patients’ health.

Download paper

Source: https://www.ema.europa.eu/

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