ANVISA – Compliance of similar medicines

Anvisa issues Service Orientation N°79/GGMED/DIRE2/ANVISA, of January 29, 2020 and one Information Notice N°2/2020 for similar medicine to identify those that hadn´t the documents submitted in compliance to RDC N° 134/2003 evaluated by the Agency.

The “similar” medicines in Brazil it´s a class that have the same requirements as a generic product, but can have a brand name.

The intention of these publications are to gather information about the registered condition of the products, in which efficacy and safety by Pharmaceutical Equivalence and/or Bioequivalence have been proven, making it easier the identification of medicines that may already can be included in the list of interchangeable similar drugs.

To participle in the Information Notice, holders of similar medicines must have Bioequivalence study, Pharmaceutical Equivalence and/or Bioisention studies filed at Anvisa until January 30, 2020.

Medicines that had performed Bioequivalence or tried to Biowave a product by Biopharmaceutics Classification System (BCS) must already have had the study evaluated and approved by Anvisa.

It is important to remember that the product cannot have its renewal waiting at the appeal phase.

The batches used to carry out the studies must not depend on any post-registration change approval not yet granted.

Companies that meet the requirements of the Notice until 29/03/2020, to provide the requested documents.

But after all, what is the importance of compliance with RDC N° 134/2003?

The RDC N° 134/2003 was a major regulatory landmark in the country that brought the requirements to put the similar medicine´s in the same level of requirements as the generics. With an adaptation phase all the products under this classification should prove their bioequivalence or pharmaceutical equivalence compared to the reference medicine chosen by Anvisa.

It was also required to present all the production information and quality control reports for the raw materials (including API´s DMF´s) and finished product, matching it´s technical quality requirements to generic medicines.

Access Service Orientation N°79/GGMED/DIRE2/ANVISA here

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