• 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. ...
  • 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’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...
  • Regulatory NewsRegulatory News

    Quality metrics: FDA wants feedback on pared-down program

    The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.   The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unv...
  • Feature ArticlesFeature Articles

    The role of metrics in regulatory advertising and promotion

    Metrics can provide valuable information about business operations and, if used appropriately, can provide insight into key process efficiencies and challenges. This article discusses the role of metrics in regulatory advertising and promotion and how they can be used to increase efficiencies for the promotional review process.   Introduction The review of promotional materials and their associated processes may vary through a content’s lifecycle, from conception t...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 2: Quality, safety and efficacy, and postmarket surveillance

    The article compares and contrasts the regulatory requirements for herbal medicinal products (HMPs), herbal-based medical devices and botanical food supplements in the EU. It is part 2 of a two-part article – Part 1 presented the definitions, main regulations, and documentation requirements for placing the products on the market; Part 2 will address quality, the strength of evidence supporting the safety and efficacy, and postmarket surveillance (PMS) requirements across...
  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...
  • RF Quarterly

    Data integrity and compliance with GxP: A pragmatic approach

    Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...