{"id":1118,"date":"2026-05-18T10:13:57","date_gmt":"2026-05-18T13:13:57","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1118"},"modified":"2026-05-18T10:13:57","modified_gmt":"2026-05-18T13:13:57","slug":"anvisa-proposed-revision-of-rdc-no-166-2017-international-harmonization-of-analytical-method-validation-parameters","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/05\/18\/anvisa-proposed-revision-of-rdc-no-166-2017-international-harmonization-of-analytical-method-validation-parameters\/","title":{"rendered":"ANVISA &#8211; Proposed revision of RDC No. 166\/2017: international harmonization of analytical method validation parameters."},"content":{"rendered":"<p><span style=\"color: #333333;\">The validation of analytical procedures is an integral part of the registration and post-registration stages of medicines, aiming to ensure the reliability of results and sustain technical evidence of quality.<\/span><\/p>\n<p><span style=\"color: #333333;\">Resolution RE No. 899\/2003 represented the first structured milestone for the regulated sector by introducing guidelines for the validation of analytical and bioanalytical methods with an advisory nature, aiming at the standardization of concepts and practices in Brazil. Subsequently, RDC No. 166\/2017 consolidated these requirements into a regulation, adopting a detailed approach by defining the parameters and criteria applicable to analytical validation for APIs, medicines, and biological products. Complementarily, Guide No. 10\/2017 recommended models and procedures for statistical analysis to support compliance with the aforementioned regulation, already allowing the adoption of alternative approaches, provided they were technically and scientifically grounded in compliance with current regulatory requirements.<\/span><\/p>\n<p><span style=\"color: #333333;\">The experience gained since the publication of RDC No. 166\/2017 has made it possible to identify that certain validation requirements currently required are not aligned with international guidelines. The theme, which was part of the Regulatory Agendas for 2021-2023, 2024-2025, and 2026-2027, resulted in Vote No. 65\/2026\/SEI\/DIRE5\/ANVISA, which approved the opening of a new regulatory stage.<\/span><\/p>\n<p><span style=\"color: #333333;\">As part of the international regulatory convergence, ANVISA published Public Consultation No. 1,391, dated March 25, 2026, aimed at the revision of RDC No. 166\/2017. The proposed draft of the new RDC establishes general criteria for the validation of analytical procedures employed in APIs, medicines, and biological products in release and stability testing.<\/span><\/p>\n<p><span style=\"color: #333333;\">The main objective of the initiative is to harmonize and internalize national requirements with the guidelines of the International\u00a0Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH Q2(R2) (Validation of Analytical Procedures) and ICH Q14 (Analytical Procedure Development). Currently adopted by several international authorities, these guides reflect the scientific and regulatory evolution of the sector, seeking to raise the quality of analyses, strengthen sanitary safety, and provide greater predictability to the medicine regularization processes in the country.<\/span><\/p>\n<p><span style=\"color: #333333;\">In addition to the draft RDC, ANVISA presented the proposal for two guides based on the ICH Q2(R2) and ICH Q14 guidelines. Although the technical and scientific content is preserved in its entirety, the documents were internalized considering the administrative and legal framework in force in the country. This adaptation, present in the translation and in the cited references, ensures the necessary regulatory and advisory framework for the national scenario.<\/span><\/p>\n<ul>\n<li><span style=\"color: #333333;\">References to Law No. 6,360\/1976 and Law No. 9,782\/1999, which establish the Agency&#8217;s competence.<\/span><\/li>\n<li><span style=\"color: #333333;\">Terminologies and references to local regulations for the Brazilian scenario, such as post-registration changes (RDC No. 73\/2016) and forced degradation studies (RDC No. 964\/2025), ensuring harmony among ANVISA&#8217;s various internal regulations.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #333333;\">The proposed changes focus predominantly on the manner of planning, conducting, and documenting the studies, while preserving consolidated scientific parameters. The draft signals the transition toward a regulatory model based on principles and risk assessment, resulting in a regulation that is more aligned with ICH guidelines. This new approach provides the sector with greater evidence-based flexibility, while simultaneously requiring more in-depth technical discussions and robust scientific justifications for defining validation strategies conditioned on the method&#8217;s objective, the nature of the analyte, and the analytical technique employed.<\/span><\/p>\n<p><span style=\"color: #333333;\">In this context of alignment with ICH Q2(R2) and ICH Q14, key advancements include the possibility of adopting combined approaches for accuracy and precision, the treatment of robustness as data intrinsic to development, and the opening for discussions regarding the use of working standards.<\/span><\/p>\n<p><span style=\"color: #333333;\">The internalization of these guides transcends the execution of a checklist of tests, prioritizing the scientific demonstration that the procedure is fit for its intended purpose, which allows for a holistic view and a more assertive analysis of the total analytical error. In this perspective, robustness is integrated into the development phase as an essential element of method understanding, consolidating itself as a design attribute rather than just a final verification.<\/span><\/p>\n<p><span style=\"color: #333333;\">The following table summarizes, in a comparative manner, the requirements set forth in RDC 166\/2017, in the text of the new draft of the RDC, and the ICH Q2(R2) and ICH Q14 Guidelines, highlighting the ongoing regulatory harmonization movement.<\/span><\/p>\n<table width=\"567\">\n<tbody>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Item<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\"><strong>RDC n\u00b0 166\/17<\/strong><\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\"><strong>Public Consultation No. 1,391, dated March 25, 2026<\/strong><\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\"><strong>ICH Q2R2<\/strong><\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\"><strong>ICH Q14<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Compendial method<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Parameters defined.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Partial validation study.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" rowspan=\"3\" width=\"153\"><span style=\"color: #333333;\"><strong>Partial validation<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">At a minimum, precision, accuracy, and selectivity.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Performance characteristics should be established based on risk assessment and the specific characteristics of the test.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #333333;\">Performance characteristics: description of a parameter that, regardless of the technology, ensures the quality of the measured result. Typically, accuracy, precision, specificity\/selectivity, and range are considered performance characteristics;<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/td>\n<td rowspan=\"3\" width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/p>\n<p><span style=\"color: #333333;\">Subset of performance characteristics.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"73\"><span style=\"color: #333333;\">For impurities, consider the LOQ.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">For impurities, consider the LOQ.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"73\"><span style=\"color: #333333;\">For limit assays, evaluate selectivity and the limit of detection.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">For limit assays, evaluate selectivity and the limit of detection.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Method transfer<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Parameters defined.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/p>\n<p><span style=\"color: #333333;\">Partial or complete validation must be performed.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #333333;\">The extent of the validation depends on the performance characteristics affected by the modification and must ensure that the analytical procedure continues to meet the requirements necessary for its purpose.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Parameters not defined.<\/span><\/p>\n<p><span style=\"color: #333333;\">Should be considered in the context of<\/span><\/p>\n<p><span style=\"color: #333333;\">analytical lifecycle changes according to ICH Q14 (partial or total revalidation and\/or comparative analysis of representative samples). Justifications for not performing additional tests are accepted.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">The attributes of the analytical procedure are evaluated and the criteria are met after the change; and\/or the results are comparable.<\/span><\/p>\n<p><span style=\"color: #333333;\">&#8211; Partial or total revalidation of the performance characteristics of the analytical procedure; and\/or<\/span><\/p>\n<p><span style=\"color: #333333;\">&#8211; Comparative analysis of representative samples and reference materials; or<\/span><\/p>\n<p><span style=\"color: #333333;\">&#8211; Justification for not performing additional transfer experiments.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Documentation\/Raw Data<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Calculations, Statistics; Selectivity;<\/span><\/p>\n<p><span style=\"color: #333333;\">Description.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions it without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>System Suitability<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Perform system verification after each analytical run.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">An integral part of analytical procedures, generally established during their development phase and subject to review by Anvisa.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">An integral part of analytical procedures, it is usually established during the development phase as a regular check of the analytical procedure&#8217;s performance.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Relationships of control are established through prior knowledge (general principles of the technique) and during the development of the procedure.<\/span><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\" width=\"39\"><span style=\"color: #333333;\"><strong>Chemical Substances<\/strong><\/span><\/td>\n<td width=\"114\"><strong><span style=\"color: #333333;\">Pharmacopoeia Chemical Reference Substance (PCRS)<\/span><\/strong><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Permitted for use in analytical validation.<\/span><\/td>\n<td rowspan=\"2\" width=\"113\"><span style=\"color: #333333;\">Reference materials or other properly characterized materials, with documented identity, purity, or any other necessary characteristics, should be used in validation studies.<\/span><\/td>\n<td rowspan=\"3\" width=\"113\"><span style=\"color: #333333;\">Os materiais de refer\u00eancia podem incluir subst\u00e2ncias qu\u00edmicas de refer\u00eancia nacionais\/internacionais, subst\u00e2ncias qu\u00edmicas de refer\u00eancia farmacopeicas ou subst\u00e2ncias qu\u00edmicas de refer\u00eancia prim\u00e1rios\/secund\u00e1rios internos.<\/span><\/td>\n<td rowspan=\"3\" width=\"113\"><span style=\"color: #333333;\">Os materiais de refer\u00eancia podem incluir subst\u00e2ncias qu\u00edmicas de refer\u00eancia nacionais\/internacionais, subst\u00e2ncias qu\u00edmicas de refer\u00eancia farmacopeicas ou subst\u00e2ncias qu\u00edmicas de refer\u00eancia prim\u00e1rios\/secund\u00e1rios internos.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Characterized Chemical Reference Substance (CCRS)<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Use is permitted in analytical validation, subject to a characterization report.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Working Standard<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Use permitted in routine laboratory settings.<\/span><\/p>\n<p><span style=\"color: #333333;\">The use of SQT for analytical method validation purposes is not permitted.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"6\" width=\"39\"><span style=\"color: #333333;\"><strong>Linearity<\/strong><\/span><\/td>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Number of replicates at each concentration<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">3 replicates<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Assessing the significance of the regression<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Yes.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions it without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Evaluation of the correlation coefficient<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">0.990<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions it without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Residual analysis<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Yes, homoscedastics.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions it without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Response vs. Concentration Graph<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Yes.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Yes.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Statistical significance<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Yes &#8211; 5%.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions it without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"5\" width=\"39\"><span style=\"color: #333333;\"><strong>Working range<\/strong><\/span><\/td>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Model<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Linear range<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">The interval is the range between the lowest and highest results in which the analytical procedure has an adequate level of precision, accuracy, and response.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">This corresponds to the lowest and highest levels of the quality attribute to be measured for which the analytical procedure provides reliable results.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">The stated range for which the required accuracy and precision characteristics are demonstrated.<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Assay<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">80% &#8211; 120%<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">80% &#8211; 120%<\/span><\/td>\n<td rowspan=\"4\" width=\"113\"><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Impurities<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">LOQ &#8211; 120%<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">LOQ &#8211; 120%<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Uniformity of Content<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">70% &#8211; 130%<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">70% &#8211; 130%<\/span><\/td>\n<\/tr>\n<tr>\n<td width=\"114\"><span style=\"color: #333333;\"><strong>Dissolution<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">-20% of the lowest expected concentration to +20% of the highest expected concentration based on the dissolution profile.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Immediate Release:<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #333333;\">&#8211; 1 point: Q &#8211; 45% of the lowest dosage to 130% of the declared content for the highest dosage;<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #333333;\">&#8211; Multiple points: Lower limit of the reportable range or LOQ to 130% of the declared content for the highest dosage.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #333333;\">Modified Release: Lower limit of the reportable range or LOQ to 130% of the declared content for the highest dosage.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Matrix Effect<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Present.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions the interference of the matrix in the evaluation of selectivity\/specificity without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions the interference of the matrix in the evaluation of selectivity\/specificity without specifying.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It mentions the interference of the matrix in the evaluation of selectivity\/specificity without specifying.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Spiked sample<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">For unknown impurities,<\/span><\/p>\n<p><span style=\"color: #333333;\">the sample should be evaluated using the<\/span><\/p>\n<p><span style=\"color: #333333;\">response of the active ingredient.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Intermediate precision<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Perform according to repeatability by<\/span><\/p>\n<p><span style=\"color: #333333;\">another analyst, on a different day.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It involves the evaluation of different conditions.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Factors to be considered should include potential sources of variability, for example, different days, different environmental conditions, different analysts, and different equipment.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Accuracy<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Calculate the RSD and recovery<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It doesn&#8217;t mention it.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">&#8211; Average percentage of recovery;<\/span><\/p>\n<p><span style=\"color: #333333;\">&#8211; Appropriate confidence interval of 100 (1-\u03b1) %.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">The acceptance criteria are determined by considering the purpose of the measurement.<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" width=\"153\"><span style=\"color: #333333;\"><strong>Robustness<\/strong><\/span><\/td>\n<td width=\"73\"><span style=\"color: #333333;\">Same criteria for accepting accuracy.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">Robustness is tested through deliberate variations in the parameters of the analytical procedure and is part of the development data, which must be made available upon request from ANVISA.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">It should be considered during the development phase and depends on the type of procedure under study.<\/span><\/p>\n<p><span style=\"color: #333333;\">The evaluation can be presented as part of the development data, on a case-by-case basis, or should be made available upon request.<\/span><\/td>\n<td width=\"113\"><span style=\"color: #333333;\">The parameters likely to influence the procedure&#8217;s performance during the expected period of use should be studied.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"color: #333333;\">This international convergence runs in parallel with the proposal for eCTD (Electronic Common Technical Document) implementation, promoting modernization and a strategic vision not only in the form of dossier submission but in the very structuring of analytical validation data.<\/span><\/p>\n<p><span style=\"color: #333333;\">By aligning national requirements with global standards, the goal is to reduce local specificities and facilitate the evaluation of technical information in other countries, ensuring that the adopted strategies are supported by technically and scientifically sound rationales. This alignment favors the recognition of analytical data by other sanitary authorities and strengthens Brazil&#8217;s insertion into a more predictable and harmonized global regulatory environment.<\/span><\/p>\n<p><span style=\"color: #333333;\">The Public Consultation will be open for contributions from April 3, 2026, to June 1, 2026 (60 days). If your company needs assistance in understanding the impact of these changes, please contact us.<\/span><\/p>\n","protected":false},"author":3,"featured_media":1120,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ANVISA - Proposed revision of RDC No. 166\/2017: international harmonization of analytical method validation parameters. - Vita<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/05\/18\/anvisa-proposed-revision-of-rdc-no-166-2017-international-harmonization-of-analytical-method-validation-parameters\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA - Proposed revision of RDC No. 166\/2017: international harmonization of analytical method validation parameters. - Vita\" \/>\n<meta property=\"og:description\" content=\"The validation of analytical procedures is an integral part of the registration and post-registration stages of medicines, aiming to ensure the reliability of results and sustain technical evidence of quality. 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