Regulatory Open Forum

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  • 1.  How do regulatory agencies coordinate across industries and regions?

    Posted 21-Apr-2023 11:07
    Edited by Indumathi Devupalli 21-Apr-2023 11:08

    How do regulatory agencies coordinate with each other to ensure effective regulation across industries and regions?

    Some background: I'm a graduate student in regulatory affairs. This topic seems like one that's difficult to understand without having regulatory job experience.



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    Indumathi Devupalli
    Boston MA
    United States
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  • 2.  RE: How do regulatory agencies coordinate across industries and regions?

    Posted 21-Apr-2023 14:24

    Hi Indumathi

    I think it's too huge a question for anyone to have experience in all of it.

    For big coordination, look at GHTF and IMDRF. For regional cooperation, look at groups like WTO, EU, PAHO, ASEAN, and GCC.

    Within the US, look at how the FDA offices have organized and reorganized themselves to cover different areas, and the meetings they have to discuss the dividing lines between drugs and biologics or devices or food supplements.

    Look at all the FDA interagency cooperation initiatives, with CBP, EPA, NIH, USDA, and so on.

    For a case study in how regulatory bodies are affected by geopolitical changes, look at Brexit.

    In the area of product registrations, you can see mutual recognition agreements, as between Turkiye and EU. You can also see many countries unilaterally agreeing to accept products previously authorized in certain other countries. For vigilance activities, some agencies notify each other and some monitor each other's databases.

    Also consider the international standards development process, since that is thoroughly entangled with regulatory activities.

    Within the whole regulatory ecosystem, I don't think there's any one regulator tasked with ensuring effective regulation across industries and regions. That probably cycles back to legislators to say when more or different regulation is needed for effectiveness.



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    Anne LeBlanc
    United States
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  • 3.  RE: How do regulatory agencies coordinate across industries and regions?

    Posted 23-Apr-2023 15:55

    Also consider looking at ICH for pharma and MDSAP for devices.

     

     

    Thomas Hutchinson MS RAC FRAPS

    Principal Consultant CMDA CQA CMQ/OE

     

     

     






  • 4.  RE: How do regulatory agencies coordinate across industries and regions?

    Posted 24-Apr-2023 08:15

    Hi Indumathi  - I completely concur with Anne LeBlanc.   This is a huge topic and requires significant information and time to describe.   There are formal relationships like IMDRF where they develop procedures that are leveraged across multi-regions and they also have formal relationships like with MDSAP(single audit) and NCARs(nonconforming information including post market sharing).   There are also specific relationships between FDA and FCC as well as FDA and CMS.   I'd say that the best support is to define your high level regulatory strategy for your business and your product and then work with others on the detailed next steps.  

    Good luck.  



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    Elisabeth George
    President
    Fort Lauderdale FL
    United States
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  • 5.  RE: How do regulatory agencies coordinate across industries and regions?

    Posted 23-Apr-2023 12:05

    I think the best example of agency coordination is ICH - the International Conference on Harmonization - that covers a broad range of science and policy. On a more micro level Divisions at FDA communicate regularly with colleagues at PMDA, EMA, HC, etc. and talk about specific development programs. One of my biggest surprises was to learn that EMA and FDA reviewers made a joint recommendation on a development program I was working on. 

    But, as Anne has correctly stated it is a huge question that regulatory professionals can spend their whole careers trying to understand the extent of it. 



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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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