{"id":9942,"date":"2024-12-11T12:48:13","date_gmt":"2024-12-11T12:48:13","guid":{"rendered":"https:\/\/amarintech.com\/?p=9942"},"modified":"2025-12-09T13:53:03","modified_gmt":"2025-12-09T13:53:03","slug":"interchangeability-guidances-for-tds","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/interchangeability-guidances-for-tds\/","title":{"rendered":"Interchangeability Guidances for TDS, Need for Harmonization"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9942\" class=\"elementor elementor-9942\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-62b6c1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"62b6c1f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-97230eb\" data-id=\"97230eb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a8f378 elementor-widget elementor-widget-text-editor\" data-id=\"5a8f378\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4><strong>Introduction:<\/strong><\/h4><p>Since 2016, both FDA and EMA keep on updating centralized guidances to define the requirements and recommendations to assess Adhesion and Skin irritation\/Sensitization for transdermal delivery systems, both for ANDA and NDA purposes.<\/p><p>In the same line, both COFEPRIS (Mexico) and ANVISA (Brazil) become pioneers in launching their guidances for interchangeability of patches since 2015, following several rounds of discussions with the pharmaceutical industry to bring the current regulations in force. Particularly, Brazil has recently published a product specific guidance for the submission of generic patches containing an antiparkinsonian, in line with the product specific guidances regularly updated by FDA.<\/p><p>If a comparison is made among them, several differences are evident, which could prevent the set of studies submitted to support a marketing application to be approved in a specific country.<\/p><p>This article intends to bring a summarized comparison highlighting the main differences on the requirements for clinical studies stated in said guidances.<\/p><p>\u00a0<\/p><h5><strong>Differences detected among Guidances\u2019 clinical requirements for a Generic TDS:<\/strong><\/h5><ul><li><strong>Studies required for an ANDA submission<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table width=\"623\"><tbody><tr><td width=\"98\"><p>Topic<\/p><\/td><td width=\"129\"><p>FDA<\/p><\/td><td width=\"129\"><p>EMA<\/p><\/td><td width=\"129\"><p>COFEPRIS<\/p><\/td><td width=\"139\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"98\"><p>Type of studies<\/p><\/td><td width=\"129\"><p>Bioequivalence,<\/p><p>Adhesion<sup>(1)<\/sup>,<\/p><p>Sensitization and\/or Irritation<\/p><\/td><td width=\"129\"><p>Bioequivalence,<\/p><p>Adhesion<sup>(1, 4)<\/sup>,<\/p><p>Sensitization and Irritation,<\/p><p>Phototoxicity.<\/p><p>\u00a0<\/p><p>\u00a0<\/p><\/td><td width=\"129\"><p>Bioequivalence,<\/p><p>Adhesion<sup>(1)<\/sup>,<\/p><p>Adhesion under normal activities<sup>(3)<\/sup>,<\/p><p>Sensitization and\/or Irritation<\/p><\/td><td width=\"139\"><p>Pharmacokinetics<sup>(2)<\/sup> + Adhesion (must be done in the same study)<\/p><p>Sensitization\/Irritation<\/p><\/td><\/tr><\/tbody><\/table><p>(1): Adhesion can be evaluated in a combined BE+Adhesion study or in a specific study.<\/p><p>(2): For ANVISA, the term Bioequivalence comprises 3 studies: Pharmacokinetics, Adhesion and Skin irritation\/sensitization.<\/p><p>(3): COFEPRIS requires test adhesion robustness of the patch to showers, moisturizers and physical exercise.<\/p><p>(4): Agency could ask for other specific studies<\/p><ul><li><strong>For Bioequivalence<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table width=\"623\"><tbody><tr><td width=\"112\"><p>Topic<\/p><\/td><td width=\"114\"><p>FDA<\/p><\/td><td width=\"129\"><p>EMA<\/p><\/td><td width=\"129\"><p>COFEPRIS<\/p><\/td><td width=\"139\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"112\"><p>Analysis of Variance, Effects to be considered in the model<\/p><\/td><td width=\"114\"><p>Treatment, Period, Sequence and Subject nested in sequence<\/p><\/td><td width=\"129\"><p>Treatment, Period, Sequence and Subject nested in sequence<\/p><\/td><td width=\"129\"><p>Treatment, Period, Sequence and Subject nested in sequence<\/p><\/td><td width=\"139\"><p>Treatment, Period, Sequence, Site of Application and Subject nested in sequence<\/p><\/td><\/tr><tr><td width=\"112\"><p>Requirement of Partial AUCs (Area under the curve)<\/p><\/td><td width=\"114\"><p>It depends on the considered API<\/p><\/td><td width=\"129\"><p>It depends on the degree of drug accumulation, when a multiple dose study is not required<\/p><\/td><td width=\"129\"><p>Not required<\/p><\/td><td width=\"139\"><p>Required (same criteria as EMA)<\/p><\/td><\/tr><\/tbody><\/table><p>\u00a0<\/p><p><strong>\u00a0<\/strong><\/p><ul><li><strong>For Patch Adhesion<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table><tbody><tr><td width=\"122\"><p>Reviewed Topic<\/p><\/td><td width=\"126\"><p>FDA<\/p><\/td><td width=\"121\"><p>EMA<\/p><\/td><td width=\"122\"><p>COFEPRIS<\/p><\/td><td width=\"121\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"122\"><p>Assessment Criteria<\/p><\/td><td width=\"126\"><p>Mean adhesion score<\/p><\/td><td width=\"121\"><p>Percentage of patch adhesion at the end of the dosing interval<\/p><\/td><td width=\"122\"><p>Cumulative adhesion score<\/p><\/td><td width=\"121\"><p>Same as EMA<\/p><\/td><\/tr><tr><td width=\"122\"><p>Adhesion under normal activities<\/p><\/td><td width=\"126\"><p>Recommended<\/p><\/td><td width=\"121\"><p>Not mentioned (only required for TDS under an NDA)\u00a0<\/p><\/td><td width=\"122\"><p>Required<\/p><\/td><td width=\"121\"><p>Nor required<\/p><\/td><\/tr><tr><td width=\"122\"><p>Statistics for secondary variables<\/p><\/td><td width=\"126\"><p>Descriptive<\/p><\/td><td width=\"121\"><p>Descriptive<\/p><\/td><td width=\"122\"><p>Descriptive<\/p><\/td><td width=\"121\"><p>Descriptive and Inferential<\/p><\/td><\/tr><\/tbody><\/table><p><strong>\u00a0<\/strong><\/p><p><strong>\u00a0<\/strong><\/p><ul><li><strong>For Irritation\/Sensitization<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table><tbody><tr><td width=\"121\"><p>Reviewed Topic<\/p><\/td><td width=\"133\"><p>FDA<\/p><\/td><td width=\"112\"><p>EMA<\/p><\/td><td width=\"122\"><p>COFEPRIS<\/p><\/td><td width=\"125\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"121\"><p>Design<\/p><\/td><td width=\"133\"><p>One group, induction phase, resting and challenge phase.<\/p><\/td><td width=\"112\"><p>Two groups (differ in patch usage time), induction phase, resting and challenge phase<\/p><\/td><td width=\"122\"><p>Same as FDA<\/p><\/td><td width=\"125\"><p>Same as FDA<\/p><p>\u00a0<\/p><p>(Formerly, it resembled EMA design)<\/p><\/td><\/tr><tr><td width=\"121\"><p>Definition of excessive skin irritation<\/p><\/td><td width=\"133\"><p>Combined score\u00a0\u00a0 \u00a0\u00a0\u00a0\u2265 3<\/p><\/td><td width=\"112\"><p>Combined score\u00a0\u00a0 \u2265 4<\/p><\/td><td width=\"122\"><p>Dermal response score 3 -7 or any dermal response combined with other effect<\/p><\/td><td width=\"125\"><p>Same as FDA<\/p><\/td><\/tr><tr><td width=\"121\"><p>Dermal Response scale for Other Effects<\/p><\/td><td width=\"133\"><p>\u00a0Letters and numerical equivalents: A(0), B(1), C(2), F(3), G(3) and H(3). The higher the number, the higher the response.<\/p><\/td><td width=\"112\"><p>Numbers from 0 to 4, different assignation of dermal responses than FDA<\/p><\/td><td width=\"122\"><p>Same as FDA, without numerical equivalents for letters (A to H)<\/p><\/td><td width=\"125\"><p>Numbers from 0 to 4 (including 0+, and different assignation of dermal responses than FDA and EMA)<\/p><\/td><\/tr><tr><td width=\"121\"><p>Adhesion evaluation during induction phase (assigning scores)<\/p><\/td><td width=\"133\"><p>Not required<\/p><\/td><td width=\"112\"><p>Not required<\/p><\/td><td width=\"122\"><p>Not mentioned<\/p><\/td><td width=\"125\"><p>Required*<\/p><p>\u00a0<\/p><\/td><\/tr><tr><td width=\"121\"><p>Sensitization analysis<\/p><\/td><td width=\"133\"><p>Descriptive statistics only<\/p><\/td><td width=\"112\"><p>Tabulations of dermal response scores \u22652.<\/p><p>No further stats required.<\/p><\/td><td width=\"122\"><p>Mean response of Test between 80%-125% of that of RLD<\/p><\/td><td width=\"125\"><p>Degree of sensitization: Test \u2264 RLD.<\/p><p>Occurrence time: Test \u2265 RLD.<\/p><\/td><\/tr><\/tbody><\/table><p>*: It allows the use of tape to reinforce patch detachments.<\/p><p>\u00a0<\/p><h4><strong>Conclusions<\/strong><\/h4><p>Although the target remains the same, i.e., to yield and interchangeable TDS, the clinical topics required by the guidances of agencies like Brazil and Mexico to approve a generic TDS are different from EMA and\/or FDA.<\/p><p>This scenario obligates the Sponsors to be highly tuned with the respective agency to agree the expected set of studies to be included in the clinical package submission.<\/p><p>Moreover, experience says that even regulatory evaluators are approached during clinical plan development, their opinions are not necessarily binding to agencies\u2019 thinking and\/or final decision, so some risks are pre-assumed when running the agreed clinical trials.<\/p><p>Consequently, the challenge would be to advance to more harmonized guidances and opinion-binding definitions by regulatory evaluators so that the submissions of generic patches can be reviewed in a more reasonable and equalized scenario.<\/p><p>\u00a0<\/p><h4><strong>References<\/strong><\/h4><ul><li>Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry, Draft, CDER\/FDA, Oct 2018.<\/li><li>Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, EMA\/CHMP\/EWP\/280\/96 Rev1, 20-Nov-14. Last access: Nov 11, 2024.<\/li><\/ul><p>(<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf\">https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf<\/a>)<\/p><ul><li>Product-Specific Guidances for Generic Drug Development, FDA. Last access: Nov 11, 2024. (<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/psg\/index.cfm?event=Home.Letter&amp;searchLetter=B#letterSearchBar\">https:\/\/www.accessdata.fda.gov\/scripts\/cder\/psg\/index.cfm?event=Home.Letter&amp;searchLetter=B#letterSearchBar<\/a>)<\/li><li>Di\u00e1rio Oficial da Uni\u00e3o, Instruc\u00e3o Normativa \u2013 IN N\u00ba 328, de 9 de Outubro de 2024. Last Access Nov 11, 2024: <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/instrucao-normativa-in-n-328-de-9-de-outubro-de-2024-589783953\">https:\/\/www.in.gov.br\/en\/web\/dou\/-\/instrucao-normativa-in-n-328-de-9-de-outubro-de-2024-589783953<\/a><\/li><li>Consulta P\u00fablica N\u00ba 760, 27\/Dezembro 2019, Public Consultative Proposal: Criteria for conduction of BA\/BE studies. Last access Nov 11, 2024: <a href=\"https:\/\/sindusfarma.org.br\/uploads\/files\/6c61-jessica-neto\/Boletins\/B_AR_n%C2%BA_004.2020%20-%20cp%20760%20-%20bioequivalencia%20e%20biodisponibilidade%20-%20Copy%201.pdf\">https:\/\/sindusfarma.org.br\/uploads\/files\/6c61-jessica-neto\/Boletins\/B_AR_n%C2%BA_004.2020%20-%20cp%20760%20-%20bioequivalencia%20e%20biodisponibilidade%20-%20Copy%201.pdf<\/a><\/li><li>Requirements for the registration of generic transdermal systems in Latin America. 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elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"d24a003\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a1925e7\" data-id=\"a1925e7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-afb4c3b elementor-widget elementor-widget-heading\" data-id=\"afb4c3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.cuervoestudio.com.ar\/\">Copyright \u00a92021 Amarin Technologies \nTodos los derechos reservados - Desarrollo by <u>Cuervo estudio<\/u><\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3ebecc6\" data-id=\"3ebecc6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process.<\/p>\n<p>There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. The experience gathered till now seems to be enough to start considering a harmonization process.<\/p>","protected":false},"author":1,"featured_media":10786,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50,49],"tags":[64,62,63,56],"class_list":["post-9942","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-challenges","category-technology","tag-bioequivalence","tag-fda","tag-regulation","tag-transdermal"],"_links":{"self":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/9942","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/comments?post=9942"}],"version-history":[{"count":4,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/9942\/revisions"}],"predecessor-version":[{"id":10790,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/9942\/revisions\/10790"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/media\/10786"}],"wp:attachment":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/media?parent=9942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/categories?post=9942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/tags?post=9942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}