Colombia issues draft decree for registration of biologicals

Home/Guidelines | Posted 22/03/2013 post-comment2 Post your comment

Last update:  10 January 2014

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 productos bioterapéuticos similares (similar biotherapeutic products), in Colombia.

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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 which aims to facilitate the registration of productos bioterapéuticos similares.

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 2013ógicos%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 productos bioterapéuticos similares 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 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.

The ministry published proposed changes to the draft on its website on 25 June 2013 and published comments received after the fourth round of discussions on the draft decree on 12 September 2013. To date, however, the Ministry has still not published finalized guidance.

Editor’s comment
It should be noted that productos bioterapéuticos similares approved in Colombia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. 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.

If you would like to receive a copy* of the proposed draft decree, please email us.

*For profit organizations subjected to a fee

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Source: Ministerio de Salud y Protección Social de Colombia

comment icon Comments (2)
Post your comment
Posted 12/06/2013 by Dr Michelle D, GaBI Online Editorial Office
Response to ‘English Guideline’

Dear Mr Gundecha,
No, what we mean is that biosimilars approved in Colombia might not be authorized following as strict a regulatory process as is required for approval of biosimilars in the EU.
Thank you and regards,

Posted 27/03/2013 by Mr. Sachin Gundecha
English Guideline

Please publish an English version of the guideline.

Do you mean that biosimilars which are not approved by EMA will not be able to registered in Colombia?

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