ANVISA and medicines and biological products releases
Over the past few days, the Federal Government has been taking several measures to mitigate the effects of the disease, trying to curb the entry of the Coronavirus in Brazil and following the global move to contain its expansion. Actions, such as isolation and quarantine, are being made daily. Law No. 13,979 / 2020* was enacted; however, part of its forecasts still needed specific regulation.
In this sense, ANVISA (Brazilian Health Regulatory Agency), the regulatory agency responsible for entry into the country of medicines, biological, and consumer products, created Resolution RDC No. 348* on March 17, 2020. This standard defines the criteria and extraordinary and temporary procedures for the treatment of petitions for registration of drugs, biological products, and products for in vitro diagnosis and post-registration change of medicines and natural products due to the international public health emergency resulting from the new Coronavirus, COVID-19.
The first point to be emphasized is the scope of this standard, restricted to applications for registration with a specific therapeutic indication for prevention or treatment of the disease caused by the new Coronavirus (COVID-19), as well as for in vitro diagnosis for SARS-CoV-2.
The Resolution also deals with petitions for post-registration changes, for medicines: (i) considered essential for the maintenance of life or used in case of serious risk to health; and (ii) limited by imminent or installed shortages in the national market due to the new Coronavirus, issues that will need to be demonstrated by the applicant entity.
The rule will be in force for 180 days, but it establishes specific deadlines for each of the procedures to be accomplished with ANVISA. The validity of its decisions is shorter and will depend on the subsequent completion of information, since the agency may accept that it is not submitted complete documentation through the subsequent filling of data and evidence required, according to a schedule and term signed with the agency.
It is important to emphasize that, according to the rule, petitions for registration of medicines and biological products will follow the terms of the Collegiate Directorate Resolution – RDC No. 205, 2017*. In turn, requests for registration of products for in vitro diagnosis will be analyzed in priority and may overlap in chronological order, provided that ANVISA’s Management of Products submits them for In Vitro Diagnosis.
Risks should be demonstrated and proven in full compliance with the requirements of the Resolution. If not, the petition shall follow the ordinary rite of analysis. In turn, the required documents should be submitted within the subsequent period granted by ANVISA; otherwise, the entity may have the cancellation or suspension of the manufacture or import of the drug until the regularization of the documentation.
In recent weeks, ANVISA has been pronouncing how it is going to be its operation in the face of the global pandemic, in addition to disseminating other potential problems that may be occurring in the country, such as issues relating to the supply of medicines and temporary discontinuation of products due to manufacturing or import problems.
Therefore, it is recommended to players in the Health Science industry to follow the news released by ANVISA, to mitigate potential damages caused by the disease and to be able to act more quickly to contain the spread of the virus in the country.
Finally, it is essential to emphasize that the Ministry of Health created Ordinance No. 356*, which deals with the measures to confront the VOCID – 19. The norm presents, for the most part, actions and procedures that should be taken by hospitals and laboratories in the determination of a case of coronavirus and the isolation measures implemented.
Daniel Lab and Daniel Law are jointly following all the news of what is happening in the world right now. If you want to follow these and other updates from ANVISA and other agencies, be sure to follow our channels or contact us by e-mail: [email protected] or [email protected]