Legislação
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Government Directive Nº 149, May 15th 2013
It approves the Inner Regiment of the National Institute of Industrial Property – INPI. -
Technical Note Nº 003 CEFAR-GTFAR-GGMED-ANVISA, April 16th 2013
It regulates the solubility assessment of active ingredients and the development of dissolution methodologies for pharmaceutical equivalence and comparative dissolution profile studies. -
It regulates the administrative procedure regarding the previous acquiescence of ANVISA for the concession of patents for pharmaceutical products and processes.
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It regulates the Good Manufacturing Practices of Traditional Phytotherapy Products.
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It regulates the performance of stability studies of active pharmaceutical ingredients
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It establishes the criteria of medications' indication, inclusion and exclusion from the Reference Medications List.
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It regulates the Guidance for the biowaiver or substitution of relative bioavailability / bioequivalence studies and it brings other foresights
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It regulates the register and the register renewal of Specific Medication.
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It regulates the Pharmaceutical Equivalence and the Comparative Dissolution Profile studies
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It regulates the Good Manufacturing Practices of Medications.
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It regulates the post-register alteration, inclusion, suspension, reactivation and cancellation of medications and it gives other foresights.
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Normative Instruction Nº 2, March 30th 2009
It determines the publication of the Guidance for the Notification of Pilot-batch Medications. -
Normative Instruction Nº 6, April 18th 2007
Guidance for the Notification of Pilot-Batch Medications. -
It regulates the register of Brand Generic Medication and it brings other foresights.
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It approves the technical regulation for Generic Medications
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Decree n° 5.563, October 11th 2005
It regulates the Innovation Law – Normative Act 127/97. It was expedited by INPI. It regulates the application of the Industrial Property Law regarding patents and certifications of invention addition. -
Guidance for the Performance of Stability Studies.
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Innovation Law: It treats about the incentives to innovation and to scientific and technologic research in the productive environment.
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List of Groups and of Specified Therapeutic Indications (GITE) It defines the classification in the category of medications' sale.
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It regulates the register of new medication.
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Guidance for the validation of analytical and bioanalytical methodologies
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Government Directive Nº 40, January 13th 1998
It is a regulation that establishes the norms for the Daily Dosage Levels of Vitamins and Minerals in Medications. -
Law Nº 6.360, September 23rd 1976
It regulates the sanitary surveillance the medications, drugs, pharmaceutical raw active ingredients and related products, cosmetics, sanitizers are subjected to and it brings other foresights. -
Resolution RDC N° 11, February 16th 2012
It regulates the functioning of analytical laboratories that perform analysis in products that are subjected to Sanitary Surveillance. -
Resolution RDC Nº 31, August 11th 2010
It regulates the Pharmaceutical Equivalence and the Comparative Dissolution Profile studies. -
Resolution RE Nº 899, May 29th 2003
It determines the publication of the “Guidance for analytical and bioanalytical methodologies validation”. -
Resolution CNS Nº 466, December 12th 2012
Regulation rules and norms of trials involving human beings. It revokes the resolutions CNS nº 196/96, 303/2000 and 404/2008. -
Resolution RDC Nº 36, June 27th 2012
It changes RDC Nº 39, June 05th 2008, and it gives other foresights. -
Normative Instruction Nº 3, May 3rd 2012
It regulates the instruments that recommend the procedures rationalization for the tecnical analysis by ANVISA of requests of responsibilities global transference of acquiescence processes in clinical trials. -
Normative Instruction Nº 2, May 3rd 2012
It regulates the requests and the import licensing assessment procedures for clinical trials regulated by RDC 39, from June 05th 2008 -
Guidance for Cosmetic Products Safety Assessment 2nd Edition (ANVISA, 2012)
It suggests the criteria for the cosmetic products safety assessment and it provides the subsidy for this matter, not limiting the companies of presenting alternative safety assessments. -
Resolution CNS Nº 446, August 11th 2011
It regulates the ethical analysis process of trials, in the extent of the courts involved -
Resolution CNS Nº 441, May 12th 2011
It states the rules for the ethical analysis of trials projects that involve the storage of human biological material or the use of material stored from previous researches. -
Resolution CNS Nº 421, June 18th 2009
It institutes a restructure in the composition of the National Comission of Ethics in Research. -
Normative Instruction Nº 4, May 11th 2009
It regulates the Guidance of Good Clinical Practices Inspection. -
Resolution RDC Nº 4, February 10th 2009
It regulates the norms of pharmacovigilance for the bearers of drug registrations for human use. -
Resolution RDC Nº 81, November 5th 2008
It brings the technical regulation of imported goods and products for sanitary surveillance purposes. -
World Medical Association Declaration of Helsinki, amend of October 2008
Ethical principles for clinical trials involving human beings. -
Resolution CNS Nº 404, August 1st 2008
It determines the acess of trials' subjects to the products that show themselves to be effective in the clinical trials. -
Resolution RDC N.º 39, June 05th 2008
It approves the REGULATION FOR PERFORMING CLINICAL TRIALS and it gives other foresights. -
Resolution CFM N º 1.885, October 22nd 2008
It is forbidden for the medical doctor to participate of trials involving human beings using placebo, when there is a known and effective treatment available. -
Resolution CNS Nº 370, March 8th 2007
It regulates the register and accreditation or the renewal of the register and accreditation of the IRB. -
Resolution RDC Nº 17, March 2nd 2007
It regulates the brand generic registration and it gives other foresights. -
Resolution RDC Nº 16, March 2nd 2007
It approves the technical regulation of generic medications, annex I. It follows this regulation the Annex II, entitled “Title page of register and post-register process of generic medications” -
Resolution RDC Nº 215, July 25th 2005
It approves the technical regulation of the lists of substances the personal hygiene products, cosmetics and perfumes should not contain – except in the conditions and with the restrictions established as Annex and that are part of this resolution. -
Resolution RDC Nº 211, July 14th 2005
It establishes the definition and the classification of personal hygiene products, cosmetics and perfumes, in conformity with annex I and II of this Resolution and it gives other foresights. -
Ordinance CVS – 4, April 29th 2005
It updates and institutes Notification and Communication Forms of Suspected Adverse Reaction to Medication and of Quality Deviation of a Medication, it regulates their workflows and it provides related foresights. -
Good Clinical Practices – Document of the Americas
Guidance of Good Clinical Practices (IV PAN AMERICAN CONGRESS FOR PHARMACEUTICAL REGULATORY HARMONIZATION), March 2005 -
Resolution CNS Nº 347, January 13th 2005
It approves the rules for the ethical analysis of research projects that involve the storage of materials or the use of materials stored in previous researches. -
Resolution CNS Nº 346, January 13th 2005
It establishes the regulation for the course of multicentric research projects in the Ethical Review Board system (CEP) – CONEP. -
Resolution RDC Nº 306, December 07th 2004
It provides the technical regulation for the management of health services residues. -
Resolution CNS Nº 340, July 8th 2004
It approves the rules for the ethical analysis and the course of research projects of the human genetics special theme area. -
Resolution RDC Nº 136, May 29th 2003
It regulates the register of new medication. -
Resolution RDC Nº 185, October 22nd 2001
It approves the Technical Regulation that treats about the register, alteration, revalidation and cancellation of medical products register in the National Agency of Sanitary Surveillance – ANVISA. -
Resolution RDC Nº 56, April 6th 2001
It brings the essential requirements of safety and efficacy of products for health. -
Resolution CNS Nº 304, August 9th 2000
Complementary norm for the area of indigenous peoples researches. -
Resolution CNS Nº 303, July 6th 2000
Complementary norm for the area of Human Reproduction, establishing sub areas that must be assessed in CONEP and delegated to CEP the analysis of other projects in the same thematic area. -
Resolution CNS Nº 301, March 16th 2000
It contemplates the opposite position of CNS and CONEP regarding the modifications of Declaration of Helsinki. -
Resolution RDC Nº 26, December 17th 1999
It regulates the expanded access programs in Brazil. -
Resolution CNS Nº 292, July 8th 1999
It establishes the specific norms for the approval of research protocols with foreign cooperation, maintaining the requirement of final approval by CONEP after CEP's approval. -
Resolution CNS Nº 251, August 7th 1997
It approves norms of research involving human beings for study of new drugs, medications, vaccines and diagnostic tests. -
Resolution CNS Nº 240, June 5th 1997
Definition of the term “users” meaning the participation in the ethical review boards of the institutions. -
Resolution CNS Nº 196, October 10th 1996
It approves the rules and norms for researches involving human beings. -
Good Clinical Practices Guidance E6 (R1).
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Resolution CFM Nº 1.098, June 30th 1983
CONSIDERING that based in Resolution CFM nº 671/75, the Federal Medicine Council accepts the Resolution of Helsinki (World Medical Association) as a guidance for the medical category in what is referred to clinical research. -
Ethical principles and rules for the protection of research human subjects.
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Declaration of Helsinki from World Medical Association, June 1964
Ethical principles for clinical research involving human beings. -
Human experimentation.
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Resolution CNS Nº 466 from December 12th 2012
Rules and norms that regulate researches involving human beings. It revokes the resolutions CNS nº 196/96, 303/2000 and 404/2008. -
Resolution - RDC Nº 27, from May 17th 2012
It regulates the minimum requirements for the validation of bioanalytical methodologies used in studies with medications register and post-register purposes. -
Good Clinical Practices - Document of the Americas
It proposes the rules for good clinical practices that can serve as a foundation for the regulatory agencies, as well as for investigators, ethical review boards, universities and companies. -
Resolution-RDC Nº. 31, from August 11th 2010
It regulates the performance of Pharmaceutical Equivalence and of Comparative Dissolution Profile studies. -
Resolution - RDC Nº 48, from October 6th 2009
It regulates the post-register alteration, inclusion, suspension, reactivation and cancellation of medications and it gives other foresights. -
Normative Instruction - IN Nº 2, from March 30th 2009
It determines the publication of the Guidance for the Notification of Pilot-Batch Medications, in annex. -
Resolution - RDC Nº 34, from June 3rd 2008
It institutes the Information System of Pharmaceutical Equivalence and Bioequivalence Studies – SINEB and the National Database of Subjects in Bioequivalence Studies – CNVB. -
Resolution-RDC Nº 17, from March 02nd 2007
It approves the Technical Regulation, in annex, for the Brand Generic register. -
Resolution RDC nº 16, from March 02nd 2007
It approves the Technical Regulation for Generic Medications, annex I. It follows this regulation the Annex II, entitled “Title page of register and post-register process of generic medications”. -
Resolution - RE Nº 1170, from April 19th 2006
It determines the publication of the “Guidance for the demonstration of relative bioavailability / bioequivalence of medications”. -
Resolution - RDC Nº. 302, from October 13th 2005
It brings the Technical Regulation for the Clinical Laboratories functioning. -
Resolution - RDC Nº 306, from September 7th 2004
It brings the Technical Regulation for the management of health services residues. -
Resolution - RDC Nº 132, from May 29th 2003
It regulates the register of specific medications. -
Resolution - RE Nº 894, from May 29th 2003
It determines the publication of the “Guidance for the protocol and technical report of a bioequivalence study”. -
Resolution - RE Nº 895, from May 29th 2003
It determines the publication of the “Guidance for the technical report writing of a relative bioavailability / bioequivalence study”. -
Resolution - RE Nº 897, from May 29th 2003
It determines the publication of the “Guidance for bioequivalence studies biowaiver or substitution”. -
Resolution - RE Nº 898, from May 29th 2003
It determines the publication of the “Guidance for planning and for accomplishing the statistical phase of relative bioavailability / bioequivalence studies”. -
Resolution - RE Nº 899, from May 29th 2003
It determines the publication of the “Guidance for the validation of analytical and bioanalytical methodologies”. -
Resolution - RDC Nº 103, from May 8th 2003
It establishes the rules for the Good Practices Certification in Medications Bioavailability / Bioequivalence. -
Resolution - RDC Nº 41, from April 28th 2000
It establishes the acceptance criteria of the units that perform pharmaceutical equivalence assays, bioavailability and bioequivalence in medications -
Resolution Nº 251, from August 7th 1997
It approves the norms of researches involving human beings for the research theme area of new drugs, medications, vaccines and diagnostic tests. -
Resolution Nº 196, from October 10th 1996
It establishes the requirements for performing clinical trials of products for health using human beings. -
Decree nº 5.053, April 22nd 2004
It approves the Regulation of Animal Health Products Inspection and the Inspection of Companies that Manufacture or Commercialize Animal Health Products, and it gives other foresights.