Monkeypox vaccines no longer need registration in Brazil

Brazil’s drug regulator Anvisa on Friday (Aug 19) unanimously decided to lift registration requirements for the import of drugs and vaccines aimed at preventing and treating monkeypox.

In practice, the resolution should simplify document assessment and increase Brazilian’s access to medicines and shots for the treatment and prevention of the disease, given the public health emergency of international concern declared by the World Health Organization.

According to the decision, the rule, described as exceptional and temporary in nature, should allow the Ministry of Health to request the agency to skip the registration of drugs and vaccines already approved by the international authorities listed.

“It is important to make clear that Anvisa is fulfilling its role as regulator. The waiver is a regulatory act. It does not mean the tacit approval of whatever is to come. In the face of yet another challenge, we are making use of a device that comes as part of the full exercise of our position,” said Anvisa head Antonio Barra Torres.

Brazil has so far confirmed 3,450 cases of monkeypox. The states of São Paulo (2,279), Rio de Janeiro (403), Minas Gerais (159), and the Federal District (141) show Brazil’s highest case tallies.

Drug or vaccine approvals issued by the following international authorities will be considered valid:

World Health Organization;
European Medicines Agency;
US Food and Drug Administration;
UK Medicines and Healthcare Products Regulatory Agency;
Japan Pharmaceuticals and Medical Devices Agency and the Japan’s Ministry of Health, Labor, and Welfare;
and Health Canada.