RDC RESOLUTION # 36 OF 27 JUNE 2012

Changes the RDC No. 39, June 5, 2008, and other provisions .

The Board of the National Health Surveillance Agency, in exercise of the powers conferred upon him by art. 11, item IV of Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of section II and in § § 1 and 3 of article. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held on June 26, 2012, adopted the following resolution Board and I, the Chairman, determine its publication:

Include art. 1 § § 3 and 4 in Article 8 of Annex I of the RDC No. 39, June 5, 2008 :

"Article 8 .........................

§ 3 ANVISA may request review of the clinical protocol , as well as the investigator's brochure by external consultants with recognized competence and free of conflicts of interest for the Process of Consent in Clinical Research.

§ 4 The consent process in clinical research with health products will be evaluated by the technical area of ANVISA , responsible for its registration."

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Article 2 Include the arts. 8 - A and 8 - B, in Annex I of the RDC No. 39, June 5, 2008:

"Article 8 ..................................

Art.8° - A. Notwithstanding the other provisions of this Regulation, ANVISA may adopt a simplified analysis for applications for approval of clinical trials in the following cases:

I - Clinical Research indicated when the application for consent has already been evaluated and approved by at least one of the regulators follows: United States (Food and Drug Administration - FDA) , Europe (European Medicines Agency - EMA) Japan (Pharmaceutical and Medical Devices Agency - PMDA), Australia (Therapeutic Goods Administration - TGA) or Canada (Health Canada), or

II - when clinical research to be evaluated by ANVISA there started recruiting research subjects in another country participating in the study.

Single paragraph. The simplified procedure caput not apply to analyzes of clinical trials with vaccines and antiretrovirals.

Art.8° - B. The simplified review procedure under Article 8 - A obey the following guidelines:

I - the applicant must submit proof that your application for consent in clinical research meets one of the criteria brought by the provisions of article 8 - A;

II - ANVISA assess whether the process was accompanied by all documentation required in Annex I of the RDC No. 39, June 5, 2008 , and

III - ANVISA assess the synopsis of the clinical protocol with respect to the security risk of the research subject and the methodological and scientific merit to generate results that support the registry and/or any post-registration changes in drug research.

§ 1º For consent process in clinical research and has petitioned awaiting review by ANVISA , it will forward to the applicant through the email address protocolo.clinico @ anvisa.gov.br , proof that the recruitment of research subjects has started in other countries and / or documentation that the study was approved by the FDA or EMA or TGA or PMDA or Health Canada .

§ 2º The absence of documentation required by this resolution will lead to summary dismissal application for simplified analysis and are not issued by any agency requirement.

§ 3º Any doubts about the synopsis of the research protocol evaluated may be subject to diligence required pelaárea responsible for examining the application of the Agency."

Amend Article 3º of Article XVIII 1 of Annex I of the RDC No. 39, June 5, 2008 , which shall henceforth read as follows:

"Article 1 ...............................

XVIII - Document 18: For clinical stage I, II , III and IV, must show proof of registration of clinical research in the database Brazilian Registry of Clinical Trials - ReBEC or proof of submission, or in the case of research already registered in other primary records of the International Clinical Trials registration Platform (ICTRP/WHO) before the effective date of this resolution , this proof of registration will be accepted to meet the provisions of this subsection." (NR)

Art. 4º This Board Resolution shall enter into force on the date of its publication.

DIRCEU BRÁS APARECIDO BARBANO

Source: http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2012/rdc0036_27_06_2012.html