PROPOSED AMENDMENT TO BIOLOGICAL DRUGS RESOLUTION NO. 4490
The Colombian Ministry of Health has issued a proposed modification to articles 2, 5 and 8 of Resolution No. 4490 of 2016 related to the registration of biological medicine processes, regarding its scope of application, “post-marketing” surveillance and enforceability.
In addition, the mentioned authority wishes to change numeral 4.5 of the current technical annex regarding the scope of clinical immunogenicity studies.
The modifications would come into force on August 19th 2017.
The proposed text can be viewed in the following link: