[en] Full text: Amendment 49: Amendment 49, 8th february 2006, excludes from the monopoly of the Brazilian Government the production, the commercialization and the use of short half-life radiopharmaceuticals for medical, agricultural and industrial uses. The most recent modification of the Brazilian Constitution was gave for the alteration of the writing in the ''alinea b'', addition of a ''alinea c'' to the interpolated proposition XXIII of the caput of article 21 and for the new writing given to interpolated proposition V of the caput of article 177. Since its publishing a great effort of all regulatories agencies in Brazil have been made looking for the harmonization of national laws bu the Brazilian Nuclear Energy C omission, Health Surveillance Agency and Brazilian Pharmacopoeia. The growth of PET-technology and consequently the use of FDG-18 and the radiopharmaceuticals in general, request a specific regulation. This regulation must be supported in the tripod: security, effectiveness and quality (FINN, 1999). In the United States, the radiopharmaceuticals are regulated under a number of agencies, because they are radioactive materials, and also are prescribed as medicine, being administered to human being. Finn (1999) alert, however, that an explicit need for the specific regulation. This necessity can be demonstrated by the signature in 21 november of 1997, in form of law, of the ''Administration Modernization Act'' (FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, 1997) applied to the Food and Drug Administration (FDA). This act, in its structure, commands that the FDA, develops practical procedures and good manufacture practice for radiopharmaceuticals, including that used in PET. In Europe, the regulations (registration and production) is made by the publishing of various ECC rules (the first was in 1965's) that are published in the form of Directives and Decision. To date tere have been 33 Council Directives, one Council Decision and one Council Regulation. In order to clarify these, numerous guidelines have been published: 11 quality guidelines; 10 biotechnology guidelines, 7 pharmacotoxicology guidelines, 10 clinical guidelines (General), 12 clinical guidelines (Therapeutics) and 3 information on medical products. Post-amendment Period: In Brazil, the first steps had started to be taken from this year. The first one of them, was the creation of the radiopharmacy subcommission, of the Brazilian Pharmacopoeia, responsible national agency for establishing the quality requirements that the medicines/drugs must obligatorily obey. These requirements include all the components used in the manufacture of medicines/drugs. Another action that deserves prominence, was the accomplishment of the ''I Workshop on Radiofarmacos'', carried through Anvisa/CNEN (National Health Surveillance Agency/Brazilian Nuclear Energy Commission), in an attempt of free-cooperation in search of parameters. Beside this others initiatives are being taken and the PUCRS (Pontifical University Catholic of the Rio Grande Do Sul) in partnership with the CRCN-NE (Regional Center of Nuclear Sciences of Northeast) and Brazilian Pharmacopoeia is in advanced period of training to promote the I Course of Specialization in Radioparmacy. However, Brazil still very behind in technician-legislative terms, and does not have any regulation for radiopharmaceuticals production yet. Prospective: An extremely important point in regards to radiopharmaceuticals is the education in radiopharmacy. As the production was always private of the CNEN the formation was always incubency of the same one, however, with the opening of the monopoly in addition of the market, the demand will be increasing. Besides, there is no course in Brazil that's teach radiopharmacy themes, even in the universities. As well an absolute lack of qualified professors, generates a preoccupying reality and that must be reviewed. However, nothing of concrete until the present moment really exists. Conclusion: For years radiopharmaceuticals have been produced in Brazil, without any specific regulati on. The evolution of PET radiopharmaceuticals in general, has introduced a new class of drugs that requires specific regulation, production facilities and the most important, qualified professionals. Even in Brazil there are no technician-legislative and any regulation a concerted effort by the various regulatory agencies has to be made to achieve a safe and effective methodology (regulation) and in this way, permit Brazil radiopharmaceutical production. Besides, is necessary introduce the theme radiopharmacy in the pharmacy schools programme, even in the post-graduated course and in this way, amplify the discussion. In fact, these actions will just minimize the problem stabilished in Brazil, but some thing has to be done and a more integrated work, including the Ministry of Health should be proposed. (author)