{"id":1161,"date":"2026-08-26T07:55:12","date_gmt":"2026-08-26T10:55:12","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=1161"},"modified":"2026-10-28T15:04:32","modified_gmt":"2026-10-28T18:04:32","slug":"anvisa-updates-qa-resolution-rdc-no-7422022","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/08\/26\/anvisa-updates-qa-resolution-rdc-no-7422022\/","title":{"rendered":"ANVISA updates Q&A on relative bioavailability\/bioequivalence studies (Resolution RDC No. 742\/2022) – updated on 10\/28\/2026"},"content":{"rendered":"

Since August 2026, ANVISA has published three updates to its Questions and Answers document on Resolution RDC No. 742\/2022, which sets out the criteria for conducting relative bioavailability\/bioequivalence (BA\/BE) studies and pharmacokinetic studies in Brazil. The August 24, 2026 update (6th Edition) revises one existing item and adds two new sections to the document; the September 8, 2026 update (7th Edition) revises two existing items; and the September 30, 2026 update (8th Edition) again revises one of the items.<\/span><\/p>\n

<\/p>\n

The role of the Q&A document<\/h2>\n

Resolution RDC No. 742\/2022 brings together the technical criteria for conducting relative bioavailability\/bioequivalence (BA\/BE) studies and pharmacokinetic studies of generic, similar, new and innovative medicinal products and biological products, structured on currently available scientific knowledge and aimed at international regulatory convergence. Since its publication, the Resolution has received targeted adjustments \u2014 such as those introduced by Resolutions RDC No. 931\/2024, No. 942\/2024 and No. 1,044\/2026 \u2014 and is complemented by specific normative instructions, including IN No. 327\/2024, on the pharmacodynamic study for topical dermatological corticosteroids, whose requirement was revoked (see our full post<\/a>). The Q&A document works as a living clarification tool, updated whenever the Agency identifies recurring questions from the pharmaceutical industry sector regarding the Resolution’s application.<\/span><\/p>\n

What changes in the Sixth Edition<\/h2>\n

Item 3.4.11, on demonstrating steady state in multiple-dose studies, was revised. The document details the two accepted methodologies for this demonstration \u2014 carried out individually, per participant and per period: (1) evaluating the difference between three concentrations taken immediately before dosing across the study’s last three administrations, which must be no more than \u00b120% of the mean of those three concentrations; or (2) evaluating the linear regression of those same three concentrations over time, with steady state considered reached when the 90% confidence interval for the estimated variation over the dosing interval falls between 80% and 125%.
\nThe update also reinforces that the effect of drug absorption at different times of day must be taken into account \u2014 evaluation time points must always correspond to the same time of day, and the area under the curve (AUC) analyzed must cover at least a 24-hour interval, even where the dosing interval is shorter.<\/p>\n

The new item 3.6 addresses the bioanalytical stage of BA\/BE studies and clarifies that, in truncated studies, the absence of samples collected during the terminal phase of the pharmacokinetic profile does not automatically require excluding that participant’s data \u2014 samples from all participants who completed the clinical stage must be quantified. Where terminal-phase samples are missing, the analysis must be conducted considering both the inclusion and the exclusion of the affected participant; if this comparison leads to different study conclusions, the company must submit a technical justification supporting the approach adopted, along with a comparative assessment of the results.<\/p>\n

The new item 3.7 addresses the calculation of the coefficient of variation (CV) in studies involving highly variable drugs. ANVISA clarifies that the N used for the CV calculation must be the same N used for the study’s other bioequivalence parameters \u2014 participants with missing data for one of the reference product periods cannot be retained solely for the CV calculation. Per the Agency’s example, if a study enrolls 60 participants, but 10 lack complete data for one period, the CV and the AUC\/Cmax parameters must be calculated based on the remaining 50 participants \u2014 since a larger N tends to produce a lower CV, which could otherwise lead to an improper widening of the acceptance interval for highly variable drugs.<\/p>\n

What changes in the Seventh Edition<\/h2>\n

Items 3.2.2, on the proportion of participants of both sexes, and 3.6.1, on truncated studies, were updated.<\/p>\n

In the previous version, the answer to item 3.2.2 provided for the inclusion of male and female participants \u201cin a balanced proportion (50% of each sex)\u201d. In the new wording, the numerical parameter was removed and the text now refers only to \u201crecruitment of participants of both sexes in a balanced proportion\u201d. The change is subtle but relevant: the expectation of balance remains, but without the explicit reference to 50\/50 between men and women. The rationale remains the same: the representativeness required by RDC 742\/2022 refers to the population that will use the medicine, and it cannot be presumed that this population is predominantly male or female.<\/p>\n

The update to item 3.6.1 retains the guidance introduced in the 6th Edition, which clarifies that, in truncated studies, the absence of samples collected during the terminal phase of the pharmacokinetic profile does not automatically require excluding the research participant’s data. All samples from participants who completed the clinical stage must be quantified. Where samples are lost in this phase, the analysis must be conducted considering both the inclusion and the exclusion of the affected participant.<\/p>\n

It should be noted that the Eighth Edition contains an error in the version history section, and the update relating to the 7th Edition is not described there.<\/span><\/p>\n

What changes in the Eighth Edition<\/h2>\n

Item 3.4.11 is altered again. In the current version, the text refers to Article 53 of RDC 742\/2022, requires that the method for demonstrating steady state be described in advance in the protocol, and states that the p-value is not considered an adequate measure, citing statistical references (Altman & Bland; the ASA Statement). The previous wording, by contrast, told the sponsor exactly how to demonstrate steady state (the demonstration was individual, for each participant and in each period, with two possible methodologies, as described in the section above relating to the 6th Edition).<\/p>\n

The two methodologies in the previous version do not depend on a p-value (one uses a percentage margin, the other a confidence interval with equivalence limits). Therefore, in principle, they remain consistent with the new text, provided they are set out and justified in the protocol. The current document, however, does not expressly confirm this.<\/span><\/p>\n

Practical impact for the pharmaceutical industry sector<\/h2>\n

For Bioequivalence Centers and study sponsors, the changes reinforce the need for methodological rigor in demonstrating steady state, handling sample losses during the bioanalytical stage, and calculating CV for highly variable drugs.<\/p>\n

Regarding the proportion of participants of both sexes, the update requires attention when planning recruitment, especially at centers where participation by one of the sexes tends to be lower.<\/p>\n

For multiple-dose studies, the sponsor may now choose and justify the method in the protocol, instead of following a fixed model. This allows the approach to be adapted to each drug. In return, it increases the demand for technical justification and the likelihood of challenges when the method is not robust. The only explicit methodological restriction in the new wording relates to the p-value and targets a common practice: hypothesis tests in which the absence of a significant difference between pre-dose concentrations is taken as evidence. With high variability or a small N, a non-significant test may simply reflect a lack of statistical power.<\/p>\n

All these points directly affect study design, the statistical robustness of results and, ultimately, ANVISA’s acceptance of the dossier for bioequivalence, relative bioavailability and pharmacokinetic studies. This is consistent with the general recommendation identified in other items of the document, which establishes that study designs that depart from the standard model described in RDC 742\/2022 may still be submitted for CETER’s prior review, under subject code 10608 \u2013 Therapeutic Equivalence – Study Protocol.<\/span><\/p>\n","protected":false},"author":3,"featured_media":1162,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"class_list":["post-1161","noticias","type-noticias","status-publish","has-post-thumbnail","hentry","categorias-brasil-anvisa"],"acf":[],"yoast_head":"\nANVISA updates Q&A on relative bioavailability\/bioequivalence studies (Resolution RDC No. 742\/2022)<\/title>\n<meta name=\"description\" content=\"On August 24, 2026, ANVISA published the 6th edition of its Questions and Answers document on Resolution RDC No. 742\/2022, which sets out the criteria for conducting relative 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