Regulatory Digest - 1 Dec 2021

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.


US FDA and WHO Highlight Agility and Collaboration at ISPE Annual Meeting & Expo

2021 ISPE Annual Meeting & Expo

Presentations by Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA; and Deus Mubangizi, Unit Head, WHO Regulation & Prequalification Department, spotlighted the unprecedented levels of agility, innovation, and collaboration that permitted the continuation of mission-critical activities while new drugs and vaccines were approved.

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Regulators Answer Industry’s Top Questions

Always a high point of the ISPE Annual Meeting & Expo, the Global Regulatory Town Hall featured ten regulators from around the world describing the challenges and successes of the past 20 months and how those experiences could shape future interactions and communications with industry and each other. Some of the key themes cited by the regulators included:

  • Innovation
    • Extensive use of new IT tools
    • Introduction of remote compliance evaluations
  • Collaboration
    • More joint inspections, increased use of mutual reliance
    • Extraordinary level of collaboration between regulators, academics, and industry, e.g., the UK Vaccines Task Force
  • Speed with agility
    • Multiple vaccines approved in many countries in record times using expedited processes, joint inspections arranged overnight
    • Many post-approval changes approved quickly (e.g., 60 days reduced to seven in the EU)
  • Expanded use of existing tools
    • In the US, use of record requests in advance of remote interactive evaluations proved beneficial
  • “Can do” attitude
    • Despite technical hurdles and increased burden, regulators made remote compliance evaluations work
  • Learnings are being leveraged
    • ANVISA is developing a framework for mutual reliance
    • PIC/S has set up a working group on “distant assessments”
    • The International Coalition of Medicines Regulatory Authorities (ICMRA) is developing a reflection paper on “distance assessments”

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Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

While quality challenges may remain a significant contributor to drug shortages, the complexity and vulnerability within supply chains, exacerbated by the conditions of the COVID-19 pandemic, has created equivalent or greater concerns for maintaining supply continuity. In a recent complementary ISPE webinar, regulators from ANSM, ANVISA, US FDA, and WHO discussed mutual reliance, regulatory flexibility, enhanced manufacturing practices, and quality maturity management as tools for maintaining supply continuity.

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ISPE Comments on Draft Guidelines

ISPE provides the opportunity for members to propose comments on selected draft regulatory guidelines or guidances. Commenting opportunities are published in the Regulatory and Quality Networking Community. ISPE recently submitted comments on:

  • MHRA Consultation on Point of Care Manufacturing
  • ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • Health Canada Post-Notice of Compliance (NOC) Changes – Quality
  • EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials

Read These ISPE Comments & More