Bioequivalence and Bioavailability Forum

Hello ElMaestro and Helmut!

The RDC nº103 from ANVISA only adresses the certification of GCP of Bioavailability Centers. In a nutshell, what they want to discuss is changes regarding the following items:

• Clarifying the need of a previous certification for the conduction of bioequivalence studies for registration of new medications, when these studies supersede clinical studies (i.e. efficacy, safety, etc.);
  
• Grant of certification only for facilities that can conduct both clinical and analytical stages, whereas, for the first, only centers in Brazil will be certified;
  
• The validity of a certification will be of 2 years starting in the date of the publication of it in the Official Gazette;
  
• The "unique certification" will be only granted for facilities located in the same municipality, metropolitan region or federal district;
  
• The new certification can be granted through technical opinion (from the ANVISA's staff) about the need of a new inspection, based on the center's history;
  
• Establishing deadlines for the granting of a new certification without interruption of the former certification;
  
• Establishing the responsabilities of the sponsors and centers for the procedures and results of the studies;
  
• The determination of a Technical Statute and minimum criteria for the complicance with GCP of Bioavailability/Bioequivalence through a Normative Statement.

The translation of these items is mine, so there may be some terms that are not in their best translation. You can see the justification (in portuguese) of the public consult here.

ANVISA is making changes in their structure, terminating some deparments and uniting some in one department. That’s why they are propposing this public consult, so that they can uptade the regulation guidelines. I think that the major change that they want to do is about the certification of foreign centers for the clinical stages. Indian centers are killing us ! The number of BE centers in Brazil has reduced a lot in the past years, because of competition with foreign centers.

And yes, ANVISA does not have the guidelines for BE in english in their website.

❝ Given the 1:7 against Germany Brazil is in a state of collective major depressive disorder.

Well, that was very overwhelming for us, but we do not had any chance against the blitzkrieg, our current team just sucks collectively. Germany has a great team and deserved to won the WC.

Best regards.

Lucas