BIO Comments on Colombia’s Proposed Biologics and Biosimilars Regulations (submitted July 25 2014)

The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin, and we refer you to our previous comments filed to the Colombian Ministry of Health on April 24th 2012¹, June 12th 2012², February 21st 2013³, and October 4th 2013⁴ for background about BIO and its interest in this Decree. These comments respond to the fifth draft of the proposed Decree, published July 10, 2014.  Please find the link to the full comments below.