{"id":71,"date":"2021-05-13T02:59:56","date_gmt":"2021-05-13T02:59:56","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=71"},"modified":"2021-07-08T18:18:00","modified_gmt":"2021-07-08T18:18:00","slug":"good-regulatory-practices","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/good-regulatory-practices\/","title":{"rendered":"Good Regulatory Practices"},"content":{"rendered":"\n

Good Regulatory Practices (GRP) <\/strong>refers to a formalized, mandatory, whole-of-government policy, that defines the common and transparent rules by which regulatory agencies develop technical regulations for all regulated sectors (i.e., cross-sector, transverse, horizontal, foundational) following international standards. GRP is the quality control mechanism for the development of regulations, ensuring on a continuous and systematic basis that government rules are relevant, of the highest quality, cost-effective, internationally aligned and least economically restrictive amongst alternatives of the same purpose.<\/p>\n\n\n\n

Elements of Good Regulatory Practices(1)<\/sup>:<\/h2>\n\n\n\n
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1. Ensuring transparency and stakeholder involvement in the development of standards, technical regulations and conformity assessment procedures:
a) Producing regulatory forecasts.
b) Maintaining a National Register of existing regulations.
c) Publishing a proposed regulation for public comment.
d) Publishing evidence or regulatory analysis that supports a proposed regulation.
e) Providing a reasonable time period for public comment on a proposed regulation and making such comments publicly available.
f) Taking into account and responding to public comment on a proposed regulation.
g) Publishing final regulations and ensuring a reasonable period for the entry into force of regulations.
h) Allowing for any interested person to submit to a regulatory authority written suggestions for the issuance, modification, or repeal of a regulation.\u00a0
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2. Maintaining internal processes or mechanisms that provide for consultation, coordination, and review among domestic authorities in the development of regulations, including for the purposes of ensuring consistency with international trade agreements and avoiding unnecessary burdens and duplication.\u00a0<\/span><\/div><\/div><\/div>\n\n\n\n
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3. Using evidence-based decision-making and regulatory analysis:
a) Relying on valid, reliable data and sound science.\u00a0
b) Placing risk assessment and risk management at the core of regulatory decision-making.\u00a0
c) Using evidence-based decision-making.\u00a0
d) Assessing the impact of regulations, including conducting Regulatory Impact Assessments (RIAs).\u00a0
Considering benefits and costs of the selected and other feasible alternatives, including the relevant impacts (such as economic, social, environmental, public health, and safety effects) as well as risks and distributional effects over time, recognizing that some costs and benefits are difficult to quantify or monetize;<\/span><\/div><\/div><\/div>\n\n\n\n
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4. Using international standards (as defined in the WTO\/TBT Committee Decision) as the basis for regulations.\u00a0<\/span><\/div><\/div><\/div>\n\n\n\n
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5. Leveraging international conformity assessment mechanisms.\u00a0<\/span><\/div><\/div><\/div>\n\n\n\n
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6. Providing for independent judicial review of regulation.\u00a0<\/span><\/div><\/div><\/div>\n\n\n\n
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7. Undertaking retrospective review of regulations for possible modification or repeal.\u00a0<\/span><\/div><\/div><\/div>\n\n\n\n
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8. Establishing a Central Regulatory Coordination Body<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

(1)<\/sup> APEC, USMCA and industry recommendations:<\/p>\n\n\n\n