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  • Regulatory NewsRegulatory News

    Australia Looks to Improve Generic Drug Authorization Process

    Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process. Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in Australia. “Our requirements are largely consistent with comparable overseas regulator...
  • Regulatory NewsRegulatory News

    FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

    The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation.   The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019. FDA is asking interested parties to submit their comments on the guideli...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

    The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirements for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). The guidance, finalized from a 2015 draft, explains what is necessary for sponsors of investigational new drugs (INDs) and applicants of new drug ...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
  • Regulatory NewsRegulatory News

    FDA Finalizes 46 Bioequivalence Guidances

    In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances. The guidances, which lay out FDA's expectations for the studies that should be done to demonstrate that a generic drug is bioequivalent to its reference product, give specific recommendations for what analytes to measure, what dissolution test methods and sampling times Some of the guidances also s...
  • Regulatory NewsRegulatory News

    FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances

    • 13 July 2017
    The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies. FDA is announcing the availability of a new draft product-specific guidance for industry for drug products containing the following active ingredients: FDA is seeking feedback on the drafts before it begins work on the final versions of product-specific guidance. FDA  last issued  a batch of s...
  • Regulatory NewsRegulatory News

    FDA Issues New and Revised Guidance for Generic Drugs

    The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs. Since formalizing its process for making such guidance available in 2010, FDA has published hundreds of product-specific bioequivalence guidances for various products. This is FDA's fourth recent release of new and revised bioequivalence guidance for generi...
  • Regulatory NewsRegulatory News

    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
  • Regulatory NewsRegulatory News

    FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

    The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis. In 2008, FDA approved Sirion Therapeutics' Durezol, a corticosteroid, to treat inflammation and pain associated with ocular surgery. Two years later, Alcon acquired the rights to Durezol from S...
  • Regulatory NewsRegulatory News

    FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

    • 04 October 2016
    The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs). The guidance is intended to help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval. This is FDA’s third r...
  • Regulatory NewsRegulatory News

    Health Canada Updates Bioavailability Requirements for Highly Variable Drugs

    Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption. Although highly variable drugs are generally safe, the Canadian regulator says, the bioequivalence of their formulations is a problem because high variability means that large numbers of subjects are required to give adequate statistical power. In addition, highly variable drugs are poor quality formul...
  • Regulatory NewsRegulatory News

    FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

    To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs. The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conduct...