Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil
| Autor: | Ralph Santos-Oliveira, Heveline Rayane Moura Roesch, Vanessa Pinheiro Amaral Lemos, Maryelle Moreira Lima Gamboa, Bruna Oliveira Rocha |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Radiofármacos/farmacovigilância
business.industry lcsh:RS1-441 Nanotechnology Legislature Public administration Radiopharmaceuticals/ surveillance Farmacovigilância/prática em radiofármacos Legislação brasileira/controle de radiofármacos Product (business) lcsh:Pharmacy and materia medica Constitutional amendment Radiopharmaceuticals/pharmacovigilance Radiofármacos/fiscalização Pharmacovigilance Pharmacovigilance/practice in radiopharmaceuticals drugs Medicine General Pharmacology Toxicology and Pharmaceutics Monopoly business Radiopharmaceuticals/regulation Brazilian legislation/radiopharmaceuticals control Radiofármacos/regulamentação |
| Zdroj: | Brazilian Journal of Pharmaceutical Sciences, Vol 50, Iss 2, Pp 285-290 (2014) Brazilian Journal of Pharmaceutical Sciences, Volume: 50, Issue: 2, Pages: 285-290, Published: APR 2014 Brazilian Journal of Pharmaceutical Sciences; Vol. 50 No. 2 (2014); 285-290 Brazilian Journal of Pharmaceutical Sciences; Vol. 50 Núm. 2 (2014); 285-290 Brazilian Journal of Pharmaceutical Sciences; v. 50 n. 2 (2014); 285-290 Brazilian Journal of Pharmaceutical Sciences Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 2175-9790 1984-8250 |
| Popis: | Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. Radiofármacos são compostos que possuem um radionucleotídeo, podendo ser emissor de radiação gama (γ) ou emissor de pósitrons (β+), ligado a uma molécula específica com finalidade diagnóstica e terapêutica. O avanço no uso dos radiofármacos tem culminado a um setor em comum com outros tipos de medicamentos: a regulamentação e fiscalização. Após 2006, a produção, a comercialização e a utilização destes medicamentos foram abertas ao mercado interno brasileiro com maior liberdade, pois a Emenda Constitucional 49, vinda da Emenda Constitucional 199/03, que retira da União o monopólio deste tipo de manipulação, ofereceu a outros centros de medicina nuclear a oportunidade desta produção. A partir desta data, a quantidade comercializada deste tipo de medicamento aumentou absurdamente e os núcleos de vigilância e regulamentação do Brasil avançaram também nos processos legislativos, criando os documentos mais voltados a Radiofármacos existentes no território nacional, as Resoluções n° 63 e n° 64. Em visão internacional, há muito ainda a ser feito em termos regulatórios no Brasil somando principalmente os assuntos vigilantes dos medicamentos como a prática de Farmacovigilância em Radiofármacos. |
| Databáze: | OpenAIRE |
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