The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 21 January 2013 the release of a new draft guideline for biologicals, including biosimilars, in Colombia.
Regulations for the registration of biological products were implemented in Colombia in 1995 through Ministerial Decree 677/1995.
Biologicals are defined in Colombia as products obtained from: a) sources such as living organisms, or parts of these tissues, viruses, serums, toxins, antitoxins, blood, blood-derived components, allergenic products, hormones, growth factors , cytokines, antibodies; and b) produced by methods including but not limited to: cell culture, cultures of micro-organisms, extraction from tissues or biological fluids, recombinant DNA techniques, transgenesis, hybridoma techniques and spread of micro-organisms embryos or animals.
The proposed draft decree provides for three routes for biological products: a complete route, a comparability route and an abbreviated route.
The proposed draft decree aims to facilitate the registration of biosimilar products in Colombia through an abbreviated pathway.
Draft decree drug registration and monitoring biological and biotechnological origin
Date: 21 January 2013
http://www.minsalud.gov.co/Normatividad/Biológicos%20y%20Biotecnológicos%20Tercera%20Versión.pdf
This proposed draft decree aims to enable the establishment of standards and regulatory procedures to ensure the quality, safety and efficacy of similar biological products available in Colombia. However, although declaring that the required information must show the quality, efficacy and safety of the medicine there are no specifications as to how these properties should be demonstrated by the applicant.
The draft was released for public consultation and feedback could be given via the Ministry of Health and Social Protection (Cra.13#32-76 Bogota D.C), with a copy to storres@minsalud.gov.co. Written submissions and comments on the new version were accepted by the Ministry of Health and Social Protection for a period of one month until 21 February 2013.
Editor’s comment
It should be noted that biosimilars approved outside of the EU may not have been authorized following as strict a regulatory process as is required by EMA. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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Source: www.gabionline.net
