{"id":1053,"date":"2021-06-16T12:38:37","date_gmt":"2021-06-16T12:38:37","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=1053"},"modified":"2021-06-16T13:10:30","modified_gmt":"2021-06-16T13:10:30","slug":"international-benchmark-reference-documents","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/tier-1\/international-benchmark-reference-documents\/","title":{"rendered":"Tier 1 \u2013 Global Benchmark Documents \u2013 Overarching Good Regulatory Practices and Technical Barriers to Trade Requirements"},"content":{"rendered":"\n

Good Regulatory Design (GRP \/ Regulatory Coherence) Policy Guide and Implementation Manual<\/h2>\n\n\n\n

Global Regulatory Cooperation Center<\/strong><\/h3>\n\n\n\n

This guide provides a landscape of international Good Regulatory Practice (GRP) policies and definitions and implementation checklist for senior policy-makers. GRP, also known as Regulatory Coherence\u201d, \u201cGood Regulatory Design\u201d or \u201cRegulatory Reform\u201d, is a horizontal, whole-of-government policy, managed at the top executive level of government, implementing the binding rules by which regulatory agencies generate regulations. GRP is the minimum set of policies that governments adopt horizontally across all of its agencies to ensure that the entire public administration of a country implements rulemaking in a consistent manner. A foundational GRP policy allows sector-specific Regulatory Convergence efforts, including international standards harmonization, to reach their full potential.<\/p>\n\n\n\n

Contents include:<\/p>\n\n\n\n

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Good Regulatory Practice Checklist<\/span><\/div><\/div><\/div>\n\n\n\n
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Regulatory Impact Assessment Checklist<\/span><\/div><\/div><\/div>\n\n\n\n
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GRP International Policy Survey<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

The guide is available in English <\/a>\/ Spanish <\/a>\/ Portuguese<\/a><\/p>\n\n\n\n

Good Regulatory Practices<\/h2>\n\n\n\n
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Ensure transparency and stakeholder involvement in the development of regulations:
Produce regulatory forecasts;
Maintain a National Regulatory Register;
Provide advanced notice of proposed rulemaking;
Provide opportunities for public comment;
Publish evidence or regulatory analysis which supports a draft rule;
Address and respond to stakeholder input;
Ensure a reasonable period for the entry into force of regulations.<\/span><\/div><\/div><\/div>\n\n\n\n
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Use valid, reliable data and sound science to guide the rule-making process;<\/span><\/div><\/div><\/div>\n\n\n\n
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Conduct Regulatory Impact Assessments (RIAs) (pre-regulation implementation);<\/span><\/div><\/div><\/div>\n\n\n\n
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Assess a regulation\u2019s impact on market competition;<\/span><\/div><\/div><\/div>\n\n\n\n
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Assess a regulation\u2019s international impact;<\/span><\/div><\/div><\/div>\n\n\n\n
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Maximize the use of relevant international standards;<\/span><\/div><\/div><\/div>\n\n\n\n
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Leverage private sector conformity assessment mechanisms;<\/span><\/div><\/div><\/div>\n\n\n\n
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Enable stakeholders to request an independent judicial review of regulation;<\/span><\/div><\/div><\/div>\n\n\n\n
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Conduct ex-post assessments of a regulation\u2019s impact (post-regulation implementation);<\/span><\/div><\/div><\/div>\n\n\n\n
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Identify a central coordinating body which is able to ensure whole-of-government implementation of the above principles.<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

Organization for Economic Co-operation and Development<\/h2>\n\n\n\n
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APEC – OECD Integrated Checklist on Regulatory Reform<\/span><\/div><\/div><\/div>\n\n\n\n
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OECD 2021 Recommendation of the Council on Regulatory Policy and Governance<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

World Trade Organization<\/h2>\n\n\n\n
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WTO TBT Agreement Text (English)<\/span><\/div><\/div><\/div>\n\n\n\n
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WTO TBT Agreement Text (Spanish)<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

The World Trade Organization \u2013 Technical Barriers to Trade Agreement constitutes the international law and binding legal obligation that each member country use international standards as a basis for national technical regulations, that technical regulations not be more trade restrictive than necessary, and that outdated technical regulations be updated or withdrawn.<\/p>\n\n\n\n

Technical Regulations and Standards<\/strong><\/h3>\n\n\n\n

Article 2: Preparation, Adoption and Application of Technical Regulations by Central Government Bodies<\/em><\/p>\n\n\n\n

2.2 Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create\u2026<\/em><\/p>\n\n\n\n

2.3 Technical regulations shall not be maintained if the circumstances or objectives giving rise to their adoption no longer exist or if the changed circumstances or objectives can be addressed in a less trade-restrictive manner.<\/em><\/p>\n\n\n\n

2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations\u2026<\/p>\n\n\n\n

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Supporting the TBT Agreement with Good Regulatory Practices Implementation Options for APEC Members<\/span><\/div><\/div><\/div>\n\n\n\n
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G\/TBT\/Rev 8 Section IX<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

The WTO Committee on Technical Barriers to Trade adopted a set of principles to which an organization engaged in the development of international standards must comply. These principles have been captured in document \u201cG\/TBT\/ 1\/REV. 8. Section IX,\u201d titled\u00a0Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with Relation to Articles 2, 5 and Annex 3 of the Agreement<\/a>.<\/p>\n\n\n\n

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REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n