• January 5, 2019
  • WTO

Brazil notifies Resolution establishing the rules for conducting clinical trials with product of advanced investigational therapy



Title of document
Resolution of The Collegiate Board of Directors RDC 260, 28 December 2018 published by Brazilian Official Gazette (5 page(s), in Portuguese)

Description
This Resolution establishes the rules for conducting clinical trials with product of advanced investigational therapy in Brazil and gives other measures.

Notifying member: Brazil

NotificationG/TBT/N/BRA/857

Objective tag
Protection of human health or safety

Objective
null

 


Agency responsible
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2563.2840 Telefax: +(55) 21 2563.5637 Email: barreirastecnicas@inmetro.gov.br Web-site: www.inmetro.gov.br/barreirastecnicas

 

Timing:

  • Submission: 28/12/2018
  • Reception: 03/01/2019
  • Distribution: 05/01/2019
  • Final date for comments: N/A
  • Proposed date of adoption: N/A

                   

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