Comparación de requisitos específicos para el registro sanitario de medicamentos biológicos en Centroamérica y República Dominicana
সংরক্ষণ করুন:
| লেখক: | , , , |
|---|---|
| বিন্যাস: | artículo original |
| বর্তমান অবস্থা: | Versión publicada |
| প্রকাশনার তারিখ: | 2022 |
| বিবরন: | Introduction: biological drugs are products that have as active ingredients one or more derivatives of biological material extracted from fluids, tissues, or microorganisms, while biotechnological ones are developed through recombinant DNA technology with the implantation of genetic material from genes belonging to one species in a different one. Objective: to compare the specific regulatory requirements for the drug registration of biological drugs, specifically recombinant DNA products, vaccines, and blood derivatives, following current Central America and the Dominican Republic current legislation. Methods: the current regulations of each country of interest were obtained. Then, a thorough review of the documents was made, and the requirements that applied to each nation were summarized and compared between them. Results: Costa Rica is the only country with specific requirements for recombinant proteins, vaccines, and blood products. Guatemala and Panama request them for the last two groups, and Nicaragua for recombinant proteins and vaccines. Conclusions: the absence of homologation complicates the work to obtain the drug registration in these territories, for which it is necessary to speed up this process through said homologation.medic |
| দেশ: | Portal de Revistas UNED |
| প্রতিষ্ঠান: | Universidad Estatal a Distancia |
| Repositorio: | Portal de Revistas UNED |
| ভাষা: | Español |
| OAI Identifier: | oai:revistas.investiga.uned.ac.cr:article/4069 |
| অনলাইন ব্যবহার করুন: | https://revistas.uned.ac.cr/index.php/repertorio/article/view/4069 |
| Access Level: | acceso abierto |
| মুখ্য শব্দ: | medicamento biológico proteína recombinante vacuna hemoderivado registro sanitario normativas biologic drug recombinant protein vaccine hemoderivative drug registration regulations |