{"id":1010,"date":"2021-06-16T12:26:06","date_gmt":"2021-06-16T12:26:06","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=1010"},"modified":"2021-06-18T10:47:55","modified_gmt":"2021-06-18T10:47:55","slug":"tier-1","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/","title":{"rendered":"Tier 1 \u2013 Good Regulatory Practices (GRP = Regulatory Coherence)"},"content":{"rendered":"\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 1: Creation of Implementation Guide; April 2017<\/h2>\n\n\n\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-fef53444\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-b1922e3d\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"295\" height=\"259\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/The-bridge-to-cooperation.jpg\" alt=\"\" class=\"wp-image-1017\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-52436545\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<p>In April 2017, the Standards Alliance in close collaboration with a variety of government and international organizations, developed and published an implementation guide entitled, \u201cThe Bridge to Cooperation: Good Regulatory Design.\u201d The guide provides an overview of good regulatory practices for governments and stakeholders including:<\/p>\n\n\n\n<div class=\"wp-block-uagb-icon-list uagb-icon-list__outer-wrap uagb-icon-list__layout-vertical uagb-icon-list__icon-at-top uagb-block-7d2f80ef\"><div class=\"uagb-icon-list__wrap\">\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-01c33234\"><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Key GRP definitions and checklist;<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-758a5f55\"><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">GRP policy landscape survey;<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-86d6ffed\"><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Regulatory Impact Assessment questions.<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n<p class=\"mb-3\">The guide is available in\u00a0<a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/good_regulatory_design_paper_-_4-24-2017_-_final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a>, <a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/Microsoft-Word-2017-06-27-Good-Regulatory-Design-Paper-FINAL-CLEAN.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol<\/a> and\u00a0<a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/Microsoft-Word-Good_Regulatory_Design_Portuguese.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Portuguese<\/a><\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 2: Assessment and Gap Analysis<\/h2>\n\n\n\n<p>Using the implementation guide as a benchmark, the Standards Alliance conducted an assessment of the GRP policies in Colombia, Costa Rica, Mexico, Peru and the United States, gauging their consistency with international best practices.<\/p>\n\n\n\n<p>The GRP GAP analysis reports, chart, and presentations (English, Spanish) are available by country:<\/p>\n\n\n\n<div class=\"wp-block-uagb-icon-list uagb-icon-list__outer-wrap uagb-icon-list__layout-vertical uagb-icon-list__icon-at-top uagb-block-ff961521 mb-3\"><div class=\"uagb-icon-list__wrap\">\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-c763dafa\"><a target=\"_self\" aria-label=\"Colombia\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/colombia\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Colombia<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-ddfdf763\"><a target=\"_self\" aria-label=\"Costa Rica\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/costa-rica\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Costa Rica<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-6fb951b4\"><a target=\"_self\" aria-label=\"Mexico\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/mexico\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Mexico<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-acc1ea90\"><a target=\"_self\" aria-label=\"Peru\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/peru\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Peru<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-842bfe90\"><a target=\"_self\" aria-label=\"United States\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/united-states\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">United States<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-4af96e64\"><a target=\"_self\" aria-label=\"All Countries\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/all-countries\/\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">All Countries<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 3: Bilateral Cooperation<\/h2>\n\n\n\n<p class=\"mb-3\">Following the completion of the gap analyses, the Standards Alliance initiated work with each project country bilaterally to begin addressing the identified gaps with the&nbsp;<a href=\"\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/international-benchmark-reference-documents\/\">international benchmarks.<\/a><\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Phase 4: Multilateral Cooperation<\/h2>\n\n\n\n<p class=\"mb-3\">Following the completion of the gap analyses, the Standards Alliance initiated work with the project countries multilaterally to begin addressing the identified gaps with the international benchmarks. AdvaMed formally connected the Americas Business Dialogue Regulatory Working Group with the Inter-American Development Bank Ibero-American and Caribbean Regulatory Improvement Network, sharing best practices of GRP policy implementing teams between the project countries.<\/p>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation 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