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  • 1.  Mutual Recognition Agreement Question

    Posted 05-Aug-2013 14:26
    Can someone explain the original rationale and current status of the Mutual Recognition Agreement enacted in the 1990s? What is the actual impact (penalty/benefit) for US manufacturers looking to sell their products in Canada and Europe and for international companies wanting to market their products in the US?  Thanks in advance for your help!

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    Christy Sasiela
    Regulatory Specialist
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  • 2.  RE:Mutual Recognition Agreement Question

    Posted 06-Aug-2013 09:47
    Hi Christy,

    If you are referring to the MRAs in place between Health Canada and various (mostly European) countries, then the deal is that these allow for reduced documentation to be submitted (for example, for evidence of GMP) for sites in those countries.  There is currently no MRA in place (between Canada and USA), meaning that companies with US-based sites would need to comply with the full set of evidence requirements to demonstrate GMP compliance.

    Link:   http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/mra-arm/index-eng.php

    Hope this helps.

    Stan North



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    Stan North
    President / Consultant (reg. affairs)
    Montreal
    Canada
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    Original Message


  • 3.  RE:Mutual Recognition Agreement Question

    Posted 06-Aug-2013 11:12
    Christy,

    Original Rationale

    For the FDA to better assure its ability to promote and protect public health by dealing with the challenges FDA faces regarding foreign drug products being brought into the US and also by addressing the challenges with available resources.  You can read more here.

    Current Status

    I previously posted the slides in this forum and YouTube about the PIC/S scheme.  It is well reflected in the PIC/S scheme. As an example for process validation, you can see how it is going here.  

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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 4.  RE:Mutual Recognition Agreement Question

    Posted 06-Aug-2013 20:56
    Hi Christa, Did someone reply to you already? The original, and current, rationale is to prevent duplication of work. Two regions with an MRA have evaluated each others' GMP standards and found them to be equivalent. Therefore importing region B will accept GMP certs, site-inspection conclusions and batch-conformity certification from exporting region A (broadly-speaking anyway; there are some caveats for individual MRAs) without these having to be redone. There is an EU-Canada MRA in place, but sadly no active EU-US MRA (the FDA cited disatifaction with some of the southern european countries) or US-Canada MRA. If a product is partially manufactured in a third country the MRA is invalid, so no benefit to a US company, I'm afraid (but no penalty either). Please note the EU also recently introduced some new rules on import of APIs, requiring a letter confirming GMP compliance from the CA in the country of manufacturer. Some countries have already been declared exempt from this requirement, but this is separate from MRAs. Best, Tom. ------------------------------------------- Thomas Macfarlane RAC Parexel Ltd Uxbridge United Kingdom -------------------------------------------
    Original Message


  • 5.  RE:Mutual Recognition Agreement Question

    Posted 08-Aug-2013 11:15
    Stan, Chang, and Thomas, thank you for your responses!

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    Christy Sasiela
    Regulatory Specialist
    National Heart Lung and Blood Institute
    Laurel MD
    United States
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    Original Message