Bioequivalence

It could be said that year 2012 and the current one have been the "age" of Bioequivalence, however this issue has a legal existence that dates back to 2005, when the Technical Standard  was promulgated by exempt Resolution 727/05.

Until May of 2012 a series of decrees and resolutions were enacted, setting deadlines and product lists for laboratories to comply with the presentation of BE studies.

Nevertheless a national laboratory presented an objection to the comptroller that resulted in the "inapplicability" of all these decrees, sending to "square one" the BE  issue in the country.

The health authority, through the Ministry of Health, reacted quickly issuing number of decrees, including DS 500/12 which approves the technical standard No. 136 and its modifications (see Res 981) that re-establishes deadlines and sets active principles for the laboratories to comply.

 

It is worth mentioning that the deadlines set forth in this legal body, in light of the nature of the studies, were virtually impossible to meet.
Apparently this was common knowledge by all the public and private technical bodies, and was absolutely expected that an appeal to delay the deadlines would be interposed, and once again it was brought before the comptroller invoking vices of "form" and "content".

Finally, in Legal Opinion No 31464 dated May 22, 2013, the comptroller discarded the arguments of form (which would have allowed to "throw down" all the “legal structure") and admits the content ones in order to “show solidarity", re-scheduling the submission of studies from the laboratories to the Ministry of Health, who extended the deadline until the end of this year 2013. 
From the above can be inferred one thing: Bioequivalence has come to stay; hopefuly this will translate into a greater access to medicines of better quality and lower cost by part of the population, this remains to be seen.

Soon this editorial will address a couple of issues that we believe will set the agenda for the pharmaceutical industry: Biological products and storage and distribution procedures.