A study published in 2021 and carried out by Ramírez-Telles et al. examined the immunogenicity, pharmacovigilance and legal documentation of biological and biotechnological drugs as aspects required in the regulations for the registration of these products. This study was conducted in nine Latin American countries – Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama – that currently have a regulatory framework for their registration [1].
Immunogenicity is defined as the capacity of an individual to generate an immune response as a consequence of the administration of a treatment. This should always be taken into account for both biological and biotechnological products. [1, 2].
In the case of regulations, immunogenicity studies are requested in practically all the countries studied in Latin America except in Honduras. In Costa Rica, Brazil, El Salvador and Panama, clinical studies are required to demonstrate the effect that the drug has on the generation of this type of response in the patient [3].
Pharmacovigilance aims to monitor drugs by contributing to their safe and rational use through the permanent evaluation of their risks. The monitoring of the safety profiles of drugs from their clinical use makes it possible to detect these cases of immunogenicity. Pharmacovigilance programmes are essential for biological and biotechnological products to ensure both their effective use and the safety of their adverse effects, especially immune responses. For this reason, their health registration requires a risk management and post-marketing pharmacovigilance plan. Honduras is the only country among those studied that does not request such a plan [3].
With regard to legal documentation, the presentation of the certificate of pharmaceutical product (CPP) and the certificate of good manufacturing practice (GMP) is an essential requirement.
The CPP provides evidence, in a standardized format, that a pharmaceutical product has been evaluated and approved by the authority of the country issuing this document, based on the quality, safety and efficacy to be shown in the market, details of the approval date and registration number, confirmation that the product is developed in accordance with GMP, the formulation of the pharmaceutical product and the sites in which the product is marketed. The GMP certificate indicates that the regulations, codes and guidelines for the manufacture of pharmaceutical products are being complied with. The presentation of this certificate is essential for the marketing authorization of a drug in most Latin American countries [2-4].
Table 1 below shows the legal documents required according to the regulations of each of the nine Latin American countries studied.
| Table 1: Comparison of the legal documents required by current regulations for the registration of biological and/or biotechnological products in the nine Latin American countries
|
| Country
|
Legal documents
|
| Brazil
|
– Copy of the GMP issued by ANVISA and by the competent health authority of the country of all the actors involved
– Copy of the proof of registration in the country of origin of the biological product
– History of the regulatory status of the product in other countries
– Local administrative documents
|
| Chile
|
– CPP issued by the authority of the country of origin, GMP and distribution, manufacturing and quality control agreements, as applicable
|
| Costa Rica
|
– CPP, WHO-type, issued by the regulatory authority of the country or region of origin or provenance
– GMP
|
| Cuba
|
– CPP, WHO-type, issued by the authorities of the country of origin and legalized at the Cuban Embassy
– GMP of the finished product and active ingredient
– Certificate of Trademark Registration in Cuba issued by the Cuban Industrial Property Office or the World Industrial Property Office
|
| Dominican Republic
|
– CPP of country of origin
– GMP
|
| El Salvador
|
– CPP, WHO-type, issued by the regulatory authority of the country or region of origin or source
– GMP
|
| Guatemala
|
– CPP, WHO-type, issued by the regulatory authority of the country or region of origin or source
– GMP
|
| Honduras
|
– CPP, WHO-type, issued by the regulatory authority of the country or region of origin or source
– GMP
|
| Panama
|
– CPP, WHO-type, issued by the regulatory authority of the country or region of origin or source
– GMP
|
| ANVISA: Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária); CPP: certificate of pharmaceutical product; GMP: good manufacturing practice; WHO: World Health Organization.
|
In the case of Central American countries, Panama, Dominican Republic and Chile, the presentation of the CPP and the GMP certificates is an indispensable requirement.
With respect to Brazil, it is also required and it is specified that it must be for the manufacturer of any stage of the product, i.e. active ingredient, bulk biological product, primary conditioner, finished product and solvent. Along with this information, it also requires a copy of the proof of registration in the country of origin of the biological product issued by the respective health authority. Cuba does likewise, although it indicates this only for the active ingredient, finished product and packaging sites [5].
Editor’s comments
Readers interested to learn more about immunogenicity of biologicals/biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Protein heterogeneity and the immunogenicity of biotherapeutics
Access to safe and effective biopharmaceuticals
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References
1. Ramirez-Telles M, Mora-Roman Jose J, Fallas-Cartin M. Registro sanitaria de medicamentos biológicos y biotecnológicos en América Latina. Ars Pharm. 2021;62(2):131-43.
2. GaBI Online – Generics and Biosimilars Initiative. Requisitos de certificación de bpf en países centroamericanos [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from:
www.gabionline.net/es/informes/requisitos-de-certificacion-de-bpf-en-paises-centroamericanos
3. GaBI Online – Generics and Biosimilars Initiative. Requisitos de certificación de BPF en Argentina, Brasil y México centroamericanos [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from:
www.gabionline.net/es/informes/requisitos-de-certificacion-de-bpf-en-argentina-brasil-y-mexico
4. GaBI Online – Generics and Biosimilars Initiative. Requisitos de certificación de BPF en los países de la Comunidad Andina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from:
www.gabionline.net/es/informes/requisitos-de-certificacion-de-bpf-en-los-paises-de-la-comunidad-andina
5. GaBI Online - Generics and Biosimilars Initiative. Requisitos de certificación de bpf en Chile, Cuba y Venezuela [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from:
www.gabionline.net/es/informes/requisitos-de-certificacion-de-bpf-en-chile-cuba-y-venezuela
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