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. 2018 Feb 19:41:e129.
doi: 10.26633/RPSP.2017.129.

Response regarding Colombian regulation of biotherapeutic products

Claudia Vaca  1 , Alejandro Gaviria  2 , Carolina Gómez  3
Affiliations

Response regarding Colombian regulation of biotherapeutic products

Claudia Vaca et al. Rev Panam Salud Publica. .
No abstract available

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References

    1. Lietzan E. A response to Dr. Gaviria: How Colombia’s biosimilar regulation departs from international norms. Rev Panam Salud Publica. 2017;41:e78. - PubMed
    2. 1. Lietzan E. A response to Dr. Gaviria: How Colombia’s biosimilar regulation departs from international norms. Rev Panam Salud Publica. 2017;41:e78. - PubMed
    1. Gaviria A, Vaca González CP, Muñoz CG, Morales AA. El debate de la regulación de medicamentos biotecnológicos: Colombia en el contexto mundial. Rev Panam Salud Publica. 2016;40(1):40–47. - PubMed
    2. 2. Gaviria A, Vaca González CP, Muñoz CG, Morales AA. El debate de la regulación de medicamentos biotecnológicos: Colombia en el contexto mundial. Rev Panam Salud Publica. 2016;40(1):40–7. - PubMed
    1. Expert Committee on Biological Standardization Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva: World Health Organization. 2009. [Accessed on 14 November 2014]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEU....
    2. 3. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva: World Health Organization; 2009. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEU... Accessed on 14 November 2014.
    1. Ministry of Health and Social Security of Colombia Resolution 0553. Guía de evaluación de la inmunogenicidad para los medicamentos biológicos; 2017. [Accessed 17 June 2017]. Available from: www.minsalud.gov.co/Normatividad_Nuevo/Resoluci%c3%b3n%20No.%2000553%20d....
    2. 4. Ministry of Health and Social Security of Colombia. Resolution 0553. Guía de evaluación de la inmunogenicidad para los medicamentos biológicos; 2017. Available from: www.minsalud.gov.co/Normatividad_Nuevo/Resoluci%c3%b3n%20No.%2000553%20d... Accessed 17 June 2017.
    1. Ministry of Health and Social Security of Colombia Decree 1782. Bogotá: MoHSS. 2014. [Accessed on 17 June 2017]. Available from: www.minsalud.gov.co/Normatividad_Nuevo/Decreto1782de2014.pdf.
    2. 5. Ministry of Health and Social Security of Colombia. Decree 1782. Bogotá: MoHSS; 2014. Available from: www.minsalud.gov.co/Normatividad_Nuevo/Decreto1782de2014.pdf Accessed on 17 June 2017.

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