História da radiofarmácia e as implicações da Emenda Constitucional N. 49

Santos-Oliveira, Ralph; Carneiro-Leão, Ana Maria dos Anjos

doi:10.1590/s1516-93322008000300006

Cited by 7 publications

(8 citation statements)

References 7 publications

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“…The first radiopharmaceuticals were commercialized in 1950. 131 Iodine was the first commercially available isotope, with Abbott Laboratories being the first company to produce radiopharmaceuticals for medical uses 8 .…”

Section: Historical Bases Of Nuclear Medicine and Radioactivitymentioning

confidence: 99%

Radiopharmaceuticals for diagnosis in nuclear medicine: a short review

2019

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Radiopharmaceuticals are radioactive compounds which have a bound radionuclide in their structure, whose purpose is directing the radionuclide to a location to be treated or to obtain images. Nuclear medicine is the medical specialty that employs radiopharmaceuticals, which has presented itself as a tremendously useful ally for medicine assisting in various diagnoses and treatments, especially for cancer. The general objective of this work is to identify the main radionuclides and metal complexes currently used as radiopharmaceuticals. The main metal complexes used as radiopharmaceuticals are compounds of technetium (99mTc) like sodium pertechnetate and methylenediphosphonate MDP-99mTc and other compounds of indium (111In), thallium (201Tl), gallium (67Ga, 68Ga), iodine (123I and 131I), chromium (51Cr), sulphur (35S), phosphorus (32P), fluorine (as fluorodeoxyglucose, 18F-FDG and sodium fluorine, Na18F), which are widely used in the nuclear medicine for diagnosis by imaging. They have been of great importance for the early diagnosis of numerous diseases, mainly cancer.Currently, technetium compounds are the majority of radiopharmaceuticals used in all countries. In Brazil, Institute of Energy and Nuclear Research (IPEN) is one of the most important distributors of radiopharmaceuticals, producing, importing and distributing them to clinics and hospitals over the country.

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Section: Historical Bases Of Nuclear Medicine and Radioactivitymentioning

confidence: 99%

Radiopharmaceuticals for diagnosis in nuclear medicine: a short review

2019

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“…Thus, there was a rupture in the monopoly of production, marketing and use of radioisotopes of short half-life, for medical, agricultural and industrial in Brazil, designed by Constitutional Amendment 49 (Santos-Oliveira, Carneiro, Leão, 2008). Originate from the Proposed Constitutional Amendment 199/03, which removes the Union's the monopoly of manipulation of radioisotopes with short half-life, Constitutional Amendment 49 facilitated the creation of new nuclear medicine centers that offer the service of tomography to the population.…”

Section: National Legislationmentioning

confidence: 99%

“…Originate from the Proposed Constitutional Amendment 199/03, which removes the Union's the monopoly of manipulation of radioisotopes with short half-life, Constitutional Amendment 49 facilitated the creation of new nuclear medicine centers that offer the service of tomography to the population. The radioisotopes of short half-life are produced by institutes of CNEN (National Commission of Nuclear Energy) as the IEN (Institute of Nuclear Engineering) (Santos-Oliveira, Carneiro-Leão, 2007;Santos-Oliveira, Carneiro-Leão, 2008).…”

Section: National Legislationmentioning

confidence: 99%

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Gamboa

Roesch

Lemos

et al. 2014

Braz. J. Pharm. Sci.

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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.Uniterms: Radiopharmaceuticals/regulation. Radiopharmaceuticals/ surveillance.Radiopharmaceuticals/ pharmacovigilance.Pharmacovigilance/practice in radiopharmaceuticals drugs. Brazilian legislation/ radiopharmaceuticals control.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.Unitermos: Radiofármacos/regulamentação. Radiofármacos/fiscalização. Radiofármacos/ farmacovigilância. Farmacovigilância/prática em radiofármacos. Legislação brasileira/controle de radiofármacos.

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“…In Brazil, this area is governed by rules of radioprotection elected by the Comissão Nacional de Energia Nuclear (CNEN) [National Commission of Nuclear Energy] and by health regulations determined by the Agência Nacional de Vigilância Sanitária (ANVISA) [National Health Surveillance Agency]. 10 Issues of Intellectual Property protection also affect the radiopharmaceutical industry, although the development of new radiopharmaceuticals is less extensive, when compared to the conventional pharmaceutical industry. A new radiopharmaceutical, as is true with a new drug, should be registered in the country seeking to guarantee its quality, safety, and efficacy, as per the Resolução da Diretoria Colegiada (RDC) [Collegiate Resolution] number 64, of 2009, in public consultation at the moment.…”

Section: Introductionmentioning

confidence: 99%

“…With exception of production, marketing, and use of short half-life radioisotopes, for medical, agricultural, and industrial uses, the monopoly was partially broken up in 2006, with Constitutional Amendment 49. 10 , 12…”

Section: Introductionmentioning

confidence: 99%

Comparative overview of innovation and patent filings in Radiopharmacy

Miranda

Lobato

Araújo

2019

Einstein (São Paulo)

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Objective To expose the current situation of the Brazilian Nuclear Medicine in relation to innovation, taking into account the Intellectual Property protection and the particularities of this field.Methods The number and the origin of patents filings from Brazil, United States and European Patent Convention countries were retrospectively compared in a 20-year period.Results The number of accumulated patents filings of conventional pharmaceuticals was ten times higher compared to the radiopharmaceuticals in the three regions studied.Conclusion The largest number of Brazilian patents filings corresponded to the international patent applications, which is related to the country development conditions, as well as to the difficulties in the process of patent filing.

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História da radiofarmácia e as implicações da Emenda Constitucional N. 49

Cited by 7 publications

References 7 publications

Radiopharmaceuticals for diagnosis in nuclear medicine: a short review

Radiopharmaceuticals for diagnosis in nuclear medicine: a short review

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Comparative overview of innovation and patent filings in Radiopharmacy

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