Approved the use of clinical research remaining stocks
Drugs for Covid-19 with registration or authorization and remnants of research conducted in the country may be used.
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Published on 09/29/2021 2:34 PM
Anvisa approved, this Wednesday (9/29), a resolution to allow the use of medicines and biological products for the treatment and prevention of Covid - 19 , provided that they have a health registration or authorization for emergency use and that they come from remaining stocks of clinical trials conducted or in progress in Brazil. The approval of the Agency's Collegiate Board, unanimously, was given during the 19th Ordinary Public Meeting of 2021, with live transmission over the internet.
The measure is in addition to other emergency actions in order to simplify the access to medicines and vaccines already Approve the s by Anvi sa. It is noteworthy that the initiative remains the health guidelines and conducting inspections of good clinical practice and other controls under re inventory of remaining drugs in clinical research centers.
“In the context of this pandemic, which is still a global concern, we cannot disregard the benefits of access to medicines and vaccines already authorized by the Agency”, highlighted director Meiruze Freitas, rapporteur of the project.
regulation
According to the resolution, medicaments and biological products for the treatment and the prevention of Covid - 19, from the remaining inventory conducted clinical trials or in progress in Brazil, may be used exceptionally, provided that the following conditions are met :
I - the Anvisa has authorized the conduct of clinical trials in Brazil;
II - the sponsor of the clinical trials or the legal representative in Brazil must authorize the exceptional use and monitor the patient for possible adverse reactions;
III – the prescribing professional must inform the patient ( or the person responsible for the patient) that the drug or biological product comes from the remaining stock of the clinical trial.
In addition, medicines and biological products must :
I - be regularized at Anvisa, through temporary authorization for emergency use, on an experimental basis, or sanitary registration;
II - be used under medical prescription, within the conditions provided for in the package insert approved by Anvisa;
III - be stored, transported and used under the conditions approved by Anvisa;
IV - be traced to the dispensing or administration stage;
V - be donated by the clinical trial sponsor or legal representative, and the donor is prohibited from receiving any kind of consideration or advantage, of any nature, from the recipient, due to the donation received;
VI - be designed are preferably users of Health System (SUS).
About the sponsor
The study sponsor must ensure that quality assurance and quality control are implemented in all areas of the institutions involved in the development of the investigational drug. The sponsor is responsible for distributing the product under investigation only to the institutions informed the submission form d the and nsaio c línico contained in d Ossie and specifico for each and nsaio c línico and authorized by the Ethics Committee in Research ( CEPs ) .
In Brazil, the sponsor is responsible for the final destination of drugs and products that were not used in the clinical trial. For the purpose of applying the standard, the sponsor may be the person, company, institution or organization responsible for initiating, administering, controlling and/or financing a clinical trial. The sponsor may also transfer its functions to a contracted company , regularly installed in the national territory , which assumes partially or totally, with Anvisa, the sponsor's attributions, designated as the Representative Organization of Clinical Research (ORPC).
Check the rapporteur's vote .
Drugs for Covid-19 with registration or authorization and remnants of research conducted in the country may be used.
Share:
Published on 09/29/2021 2:34 PM
Anvisa approved, this Wednesday (9/29), a resolution to allow the use of medicines and biological products for the treatment and prevention of Covid - 19 , provided that they have a health registration or authorization for emergency use and that they come from remaining stocks of clinical trials conducted or in progress in Brazil. The approval of the Agency's Collegiate Board, unanimously, was given during the 19th Ordinary Public Meeting of 2021, with live transmission over the internet.
The measure is in addition to other emergency actions in order to simplify the access to medicines and vaccines already Approve the s by Anvi sa. It is noteworthy that the initiative remains the health guidelines and conducting inspections of good clinical practice and other controls under re inventory of remaining drugs in clinical research centers.
“In the context of this pandemic, which is still a global concern, we cannot disregard the benefits of access to medicines and vaccines already authorized by the Agency”, highlighted director Meiruze Freitas, rapporteur of the project.
regulation
According to the resolution, medicaments and biological products for the treatment and the prevention of Covid - 19, from the remaining inventory conducted clinical trials or in progress in Brazil, may be used exceptionally, provided that the following conditions are met :
I - the Anvisa has authorized the conduct of clinical trials in Brazil;
II - the sponsor of the clinical trials or the legal representative in Brazil must authorize the exceptional use and monitor the patient for possible adverse reactions;
III – the prescribing professional must inform the patient ( or the person responsible for the patient) that the drug or biological product comes from the remaining stock of the clinical trial.
In addition, medicines and biological products must :
I - be regularized at Anvisa, through temporary authorization for emergency use, on an experimental basis, or sanitary registration;
II - be used under medical prescription, within the conditions provided for in the package insert approved by Anvisa;
III - be stored, transported and used under the conditions approved by Anvisa;
IV - be traced to the dispensing or administration stage;
V - be donated by the clinical trial sponsor or legal representative, and the donor is prohibited from receiving any kind of consideration or advantage, of any nature, from the recipient, due to the donation received;
VI - be designed are preferably users of Health System (SUS).
About the sponsor
The study sponsor must ensure that quality assurance and quality control are implemented in all areas of the institutions involved in the development of the investigational drug. The sponsor is responsible for distributing the product under investigation only to the institutions informed the submission form d the and nsaio c línico contained in d Ossie and specifico for each and nsaio c línico and authorized by the Ethics Committee in Research ( CEPs ) .
In Brazil, the sponsor is responsible for the final destination of drugs and products that were not used in the clinical trial. For the purpose of applying the standard, the sponsor may be the person, company, institution or organization responsible for initiating, administering, controlling and/or financing a clinical trial. The sponsor may also transfer its functions to a contracted company , regularly installed in the national territory , which assumes partially or totally, with Anvisa, the sponsor's attributions, designated as the Representative Organization of Clinical Research (ORPC).
Check the rapporteur's vote .
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