The National Health Surveillance Agency (Anvisa) approved, this Thursday (12), the extension of the validity of Emergency Use Authorizations for medicines and vaccines for Covid-19.
With the measure, the current authorizations will remain valid for another year. Within this period, companies that still have products in this situation must request the definitive sanitary registration. Read part of the proposal below .
New rules were also defined for new requests for emergency use authorization for vaccines and medicines. Among the changes is the determination that new emergency use assessments will be given for vaccines indicated by the Ministry of Health as necessary to support the vaccination program in Brazil.
The decision voted unanimously by the Collegiate Board was motivated by a letter from the Ministry of Health after the closing of Espin signed by Minister Marcelo Queiroga on April 22. The decisions made official in the document of the folder start to be valid 30 days after their publication in the Official Gazette of the Union.
“The need for a uniform extension of 18 standards for 365 days was highlighted in a complementary way, aiming to harmonize the regulatory maintenance period and guarantee the necessary time for observation and adaptation to the new scenario by health agencies, researchers, developers, companies , establishments in the regulated sector, as well as the population in general, allowing for discontinuities and disruptions of health standards that regulated the national scenario during the pandemic “, said Anvisa’s CEO, Antonio Barra Torres.
“I believe that the extension of the term of validity of some rules will guarantee legal certainty in the current transition scenario after the end of Espin, allowing there to be no discontinuity or disruptions in the development, regularization or supply of medicines and vaccines for Covid-19”, he said. director Cristiane Rose Jourdan at the meeting.
Proposal approved by Anvisa’s Collegiate Board:
- Maintenance of the validity of the experimental and temporary emergency use of medicines or vaccines against Covid-19 already authorized by Anvisa for up to 365 days after the revocation of the Ministry of Health ordinance, which may be extended at the request of the folder
- Maintenance of permission to grant new requests for authorization for emergency use for medicines for up to 365 days, which can be extended at the discretion of Anvisa or the Ministry of Health
- Maintenance for up to 365 days of prioritization for evaluation of clinical trials, emergency use authorization, vaccine records, diagnostic tests and drugs indicated for the treatment of Covid-19
- Maintenance for up to 365 days of the regulations that facilitated the importation of products subject to health surveillance used in the fight against Covid-19 or in the scenario of shortages
- Maintenance of authorization for the use of rapid tests for Covid-19 in pharmacies for up to 365 days or until Anvisa issues a definitive resolution on the subject
- Maintenance for up to 365 days of the Anvisa resolution that allows federal agricultural defense laboratories to perform analysis for the diagnosis of Covid-19
“The technical areas of Anvisa and the supervisory board signaled agreement with the understanding expressed by the Ministry of Health that the mitigation of the rules established during the emergency situation must be adopted cautiously, gradually and accompanied by surveillance measures combined with a rigorous analysis. of the impacts and risks that can be generated throughout the unified health system (SUS)”, said Torres.
About Espin’s shutdown
The Minister of Health Marcelo Queiroga signed, on April 22, the ordinance that established the end of the Public Health Emergency of National Importance (Espin) established in February 2020 due to Covid-19.
“The ordinance is a simple normative act: in the ordinance, we establish a vacancy period, that is, this ordinance will only take effect 30 days after its publication in the Official Gazette of the Union. It should be published in an extra edition of the Official Gazette”, said Queiroga after signing.
To the decision to end the state of emergency, the ministry attributes the improvement of the epidemiological scenario, the high vaccination coverage and the response and assistance capacity of the Unified Health System (SUS).
The classification of the disease as a pandemic is an assignment of the World Health Organization (WHO). However, countries have the autonomy to monitor epidemiological conditions at the national level and determine public policies and actions to combat the disease according to the indicators.
Source: CNN Brasil