• RF Quarterly

    An introduction to regulatory strategy

    In its simplest form, strategy can be considered bringing a new product to market, but it touches every product development lifecycle aspect and can ensure market sustainability. A limited or inadequate strategy can challenge global expansion, thus emphasizing the importance of a well-designed and executed regulatory strategy. This article identifies the requirements for developing a strategy for a drug development plan, as well as postmarketing strategy, with some global ...
  • RF Quarterly

    CMC regulatory strategy

    Regulators make benefit-risk decisions based on the three pillars of quality, safety, and efficacy. CMC is applied throughout the product development spectrum from the initial synthesis of a molecule to reach a hypothetical target, to commercial scale up and beyond. This article helps the reader navigate the CMC regulatory landscape and understand the multiple considerations needed in order to devise a strategy which is efficient with respect to cost and time to approval. ...
  • RF Quarterly

    Application of project management strategy to postapproval CMC submissions

    The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to PMBOK. This article presents opportunities for using a project management framework when strategizing for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and t...
  • Regulatory NewsRegulatory News

    Pharma groups: FDA is exceeding its authority in risk management plan guidance

    The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...
  • Regulatory NewsRegulatory News

    OPQ’s FY2021 report gives mixed review on state of drug quality

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lists both negative and positive trends in its new report assessing the state of pharmaceutical quality in FY2021. Among the setbacks are the increasing number of drug recalls, under-reporting of quality issues in field alert reports (FARs) and a growing number of products failing sampling tests.   On the bright side, OPQ said its New Inspection Protocol Project (NIPP) program has increa...
  • Feature ArticlesFeature Articles

    Getting ready for the FDA’s upcoming QMSR

    The FDA’s Quality Management System Regulation (QMSR) proposal, paired with the International Organization for Standardization’s ISO 13485:2016, is expected to deliver cost savings to medtech organizations that adhere to both requirements. This article covers the differences between QMSR, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP) so leaders can prepare for the upcoming changes.    Keywords – MDSAP, quality management, quality system regulat...
  • RF Quarterly

    Evolution of the Japanese regulatory system and agencies

    The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...
  • Regulatory NewsRegulatory News

    Back to the drawing board for FDA’s revised quality metrics plan?

    The US Food and Drug Administration’s (FDA) revised plan to collect quality metrics data from manufacturers drew criticism from one major pharmaceutical industry group on the metrics the agency is proposing, as well as its methods for developing the program. Others complained that the proposed program lacks focus, while two industry groups also expressed serious misgivings about the purpose of the overall program.   Yet on a positive note, one industry group and major ...
  • Feature ArticlesFeature Articles

    FDA ‘high-risk’ foreign inspections: Post‒COVID-19 response to GMP challenges

    This article examines the US Food and Drug Administration’s (FDA) return to inspections that were put on hold during the ongoing COVID-19 pandemic. It outlines the agency’s oversight of drug and biological products during the pandemic and its plans moving forward. The authors summarize the agency’s guidance and policies, industry considerations, and recommendations to manufacturers preparing for their next FDA inspection.   Keywords FDA, inspections, quality, risk m...
  • Regulatory NewsRegulatory News

    FDA asks manufacturers to develop risk management plans to avert shortages

    The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also recommends risk factors to consider when developing the content of the RMPs.     Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), FDA was given new authorities to collect information from manufacturers in respond...
  • Regulatory NewsRegulatory News

    Pharmaceutical industry groups suggest ICH Q9 changes

    The proposed revisions of the International Council of Harmonization’s (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm’s information technology (IT) program should be subject to the same level of risk controls as other areas within an organization, representatives of the pharmaceutical industry said in their comments on the update.   The European Medicin...
  • Regulatory NewsRegulatory News

    FDA’s revised quality metrics plan praised for offering greater flexibility

    The US Food and Drug Administration’s (FDA) revised quality metrics plan is an improvement over previous iterations as it offers more flexibility to drugmakers by giving them options on what type of metrics data to submit, according to stakeholders who spoke to Focus .   FDA also showed responsiveness to industry concerns by asking how metrics data should be submitted, either by site or by product, according to a consultant and a consumer industry group, who were aske...