• Regulatory NewsRegulatory News

    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
  • Regulatory NewsRegulatory News

    Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12

    Members of the pharmaceutical industry want the US Food and Drug Administration (FDA) to align reporting categories with the International Council for Harmonization (ICH) Q12 guideline on postapproval changes while others seek clarity on how manufacturers can use postapproval change management protocols (PACMPs) to support a lower reporting category. Others wanted clarity on established conditions (ECs) as well as non-ECs, a core tenet of the guideline.   These industr...
  • Regulatory NewsRegulatory News

    FDA sees different tactics were successful in established conditions pilot

    Manufacturers leveraged diverse approaches to defining established conditions (ECs), a core tenet of the International Council for Harmonization’s (ICH) Q12 guideline for managing post-approval changes, in its recently concluded EC pilot program, said US Food and Drug Administration (FDA) officials at a recent meeting.   Christopher Downey, review chief in FDA’s Office of Biotechnology Products in the drug center’s Office of Pharmaceutical Quality, spoke of some of the...
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    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...
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    ICH Q12: FDA guidance explains US implementation

    The US Food and Drug Administration (FDA) has issued draft guidance to help manufacturers implement the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes by explaining how manufacturers can submit established conditions (ECs) for new drug applications (NDAs) and prior approval supplements (PASs). It also reconciles ICH post-approval changes classification categories with FDA supplement categories.   A Federal Register announcement ...
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    FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

    The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.   The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a ...
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    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...