Uruguay keeps step with international rules on biotechnological drug registration.
Decree 38/2015 approving guidelines for Biotechnological Drug Registration took effect on February 13, 2015. This is the first set of guidelines in Uruguay updating drug registration requirements, in view of the complexity involved in manufacturing biological and biotechnological products. These rules kick off Uruguay’s coming into step with international, regional and World Health Organization criteria and guidelines.
The decree regulates registry requirements for biotechnological drugs, which are those containing active principles obtained from cell cultivation, microorganisms and live cells using DNA recombinant technology or hybridoma techniques. They include proteins obtained through DNA recombinant technology, monoclonal antibodies, and a more general category of other biotechnological drugs. Also covered are vaccinations containing components produced by DNA recombinant techniques.
Starting now biotech drugs can be registered either based on a complete protocol or on comparability with a Reference Biological Drug.
Given that at the effectiveness date there are biotech drugs that had been registered without requiring these studies, the rules establish the conditions for renewal, although leaving the door open for health authorities to consider evaluating renewals with active pharmacovigilance studies performed. Notwithstanding, the rules clearly establish the health policing powers that the Ministry of Health has had since its creation, in stating that additional information can be requested, if deemed necessary, even after registration has been authorized.