Brasília – The Brazilian National Health Surveillance Agency (Anvisa, in the Portuguese acronym) has reported this Friday (11th) that pharmaceutical products entering the country will be cleared faster starting this year. According to the agency, resolution RDC 15/2014 sets forth three major changes in the Certificate of Good Manufacturing Practices should make it easier to register new technologies in the country.
The first change allows the Anvisa to use third-party auditing reports in its programs. “The Anvisa will be allowed to partner up with other regulatory agencies, exchanging information and reducing the need for sending technicians abroad,” the agency has informed.
The resolution also allows companies to hire certified auditors to draft inspection reports which in turn will be used for the issuance of Certificates of Good Manufacturing Practices.
The second change is that the Anvisa is no longer issuing certificates for class I and products, and lower risk products such as gloves, syringes and some surgical instruments. According to the agency, the measure eliminates the need for production line inspection for products considered to be less complex.
The third change is that the certificate’s proof of request will be accepted in requests for registering, revalidating and altering class III and IV products, which are higher risk. “This means manufacturers will not be required to await the certificate’s issuance in order for their products to start undergoing analysis,” according to the agency.
*Translated by Gabriel Pomerancblum
