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Legislation
Resolution

Resolution - RE nº 897, of May 29, 2003
(D.O.U of 02/06/2003)


The Deputy of the Collegiate Board of Directors of the Brazilian Sanitary Surveillance Agency, in the use of the attribution vested in him by Administrative Order n. 238, of March 31, 2003,

WHEREAS

provided in Article 111, clause II, item “a” of paragraph 3 of the Bylaws approved by Administrative Order 593, of August 25, 2000, re-published in the Federal Official Journal of December 22, 2000

that the matter was submitted to the examination of the Collegiate Board of Directors, which approved the matter in a meeting held on March 6, 2003, decides:

Article 1 - To determine the publication of the " Guide for exemption and substitution of bioequivalence studies”, attached.

Article 2 – Resolution RE n. 481, of March 19, 2002, is hereby revoked.

Article 3 - This Resolution enters into force on the date of its publication.

DAVI RUMEL

ANNEX

GUIDE FOR EXEMPTION AND SUBSTITUTION OF BIOEQUIVALENCE STUDIES

1. The following types of drug products are exempt from the bioequivalence studies:
1.1. drug products administered via parenteral route (intravenous, intramuscular, subcutaneous or intratecal),such as aqueous solutions containing the same drug , in the same concentration as the reference drug product and excipients of the same function, with compatible concentration levels.
1.2. oral solutions that contain the same drug , in the same of concentration as the reference drug product and that do not contain excipients that affect gastrointestinal motility or drug absorption.
1.3. powders for reconstitution that result in a solution that meets requirements (1.1) e (1.2).
1.4. gases.
1.5. otological and ophthalmic aqueous solutions containing the same drug , in the same concentration as the reference drug product and excipients of the same function, with compatible concentration levels.
1.6. for topical drug products, not meant for systemic effect, containing the same drug , in the same concentration of the reference drug product and excipients of the same function, with compatible concentration levels, meant for otological and ophthalmic use, presented in suspension form, the results of the pharmacodynamics studies supporting the therapeutic equivalence must be presented, but the pharmacodynamic study model must be previously approved by ANVISA.
1.7. inhalant drug products and nasal sprays administered with or without a device, presented in an aqueous solution and containing the same drug , in the same concentration of the reference drug product and excipients of the same function, with compatible concentration levels.
1.8. oral use drug products whose drugs are not absorbed in the gastrointestinal tract.

2. Cases where bioequivalence may be substituted by pharmaceutical equivalence:

2.1. in the case of immediate release generic drugs (delayed or extended), with several dosages, same pharmaceutical form and equivalent formulations, produced by the same manufacturer, at the same manufacturing site, the bioequivalence study(ies) must be undertaken with the highest dosage, the lower dosage ones being exempt from this study if the drug dissolution profiles, among all dosages, are comparable according to the GUIDE FOR DISSOLUTION TESTS OF ORAL SOLID IMMEDIATE RELEASE PHARMACEUTICAL FORMS (FFSOLI). If it is impossible to use the higher dosage in the bioequivalence study, this must be technically justified. This rule is applicable to the drugs that present linear pharmacodynamics in the therapeutic range.
2.2. in the case of modified release pills (delayed or extended) with several dosages, same pharmaceutical form, proportional formulations, same mechanism of drug release, manufactured by the same producer, at the same manufacturing site , the bioequivalence studies must be undertaken with the highest dosage, the lower dosage ones being exempt from this study if the drug dissolution profiles, among all dosages, are comparable according to the GUIDE FOR DISSOLUTION TESTS OF ORAL SOLID IMMEDIATE RELEASE PHARMACEUTICAL FORMS (FFSOLI). For this comparison, at least 3 (three) different dissolution media must be used (for example, pH 1.2; 4.5 and 6.8). Furthermore, the comparative dissolution profiles of all the dosages of the test and reference product must also be presented.
2.3. drug products exempt from medical prescription, containing the drugs acetylsalicylic acid, paracetamol, dipyrone ou ibuprophen, in solid pharmaceutical form, will be exempt from the bioequivalence study if the dissolution profile is comparable to that of the reference drug product, using the comparison criteria described in the GUIDE FOR DISSOLUTION TESTS OF ORAL IMMEDIATE RELEASE SOLID PHARMACEUTICAL FORMS (FFSOLI).

2.4. topical drug products, with the exception of those provided for in item 1.6, in the same level of concentration in relation to the reference drug product and excipients of the same function, with compatible concentration levels.

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