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Brazil proposed Resolution for clinical trials with Products Advanced Research Therapies

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Brazil proposed Resolution for clinical trials with Products Advanced Research Therapies

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution defines the procedures and regulatory requirements for the reporting of clinical trials with Products Advanced Research Therapies in Brazil, including the Clinical Development Dossier (DDCTA), to be submitted to Anvisa for consent purposes.

This Resolution DOES NOT APPLY to:

I - clinical trials with the drugs referred to in Resolution RDC No. 9 of February 2, 2015 and their updates; and

II - to post-marketing clinical trials (phase IV)

This Resolution is applicable to clinical trials for the purpose of proving safety and efficacy, with Products of Advanced Research Therapies that can be registered and that will have their clinical development in Brazil.

Product covered: Clinical trials with Products Advanced Research Therapies

HS code: 98041000

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 15-12-2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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