ABSTRACT
Despite the lack of specific regulatory guidelines, many nanomedicines are on the market and their number is growing steadily. These are mainly used in cancer therapy because they require persistent toxic compounds and the tumor landscape is very difficult, which hinders effective drug treatment. The lack of formal regulation of nanomedicines and the manufacture of nanomaterials for health-related applications is a worldwide problem. Inconsistency among differentgovernment agencies results in some nanomedicines being classified as medicaldevices and others as drugs. Therefore, a global consortium for nanomaterialsregulation should be formed to advance these agendas and issue formal guidance to the research communities. Currently, in the context of nanomaterials in the European Union, we are dealing with both binding legal acts and non-binding legal acts, such as recommendations on the fair conduct of scientific research or on the application of a uniform definition of nanomaterials.
A pesar de la falta de directrices regulatorias específicas, encontramos en el mercado un número creciente de nanomedicinas. Se utilizan, sobre todo, en la terapia del cáncer, ya que requieren compuestos tóxicos persistentes y el paisaje tumoral es muy difícil, lo que dificulta un tratamiento farmacológico eficaz. La falta de regulación oficial de los nanomedicamentos y la fabricación de nanomateriales para aplicaciones relacionadas con la salud es un problema mundial. La incoherencia entre las distintas agencias gubernamentales hace que algunas nanomedicinas se clasifiquen como dispositivos médicos y otras como fármacos. Por lo tanto, debería formarse un consorcio mundial para la regulación de los nanomateriales con el fin de avanzar en esta agenda y emitir orientaciones formales para las comunidades investigadoras. En la actualidad, en el contexto de los nanomateriales en la Unión Europea, encontramos tanto herramientas jurídicas vinculantes, como no vinculantes; tal es el caso de las recomendaciones sobre la adecuada realización de investigación científica o sobre la aplicación de una definición uniforme de los nanomateriales. (AU)
Subject(s)
Humans , Government Regulation , International Health Regulations/trends , Nanostructures/administration & dosage , Nanostructures/history , Nanostructures/supply & distribution , European Union , Research Support as TopicSubject(s)
COVID-19/prevention & control , Global Health/trends , International Health Regulations/organization & administration , Pandemics/prevention & control , COVID-19/epidemiology , Global Health/statistics & numerical data , Humans , International Health Regulations/statistics & numerical data , International Health Regulations/trends , World Health OrganizationABSTRACT
AIMS: We developed a model, updated daily, to estimate undetected COVID-19 infections exiting quarantine following selectively opening New Zealand's borders to travellers from low-risk countries. METHODS: The prevalence of infectious COVID-19 cases by country was multiplied by expected monthly passenger volumes to predict the rate of arrivals. The rate of undetected infections entering the border following screening and quarantine was estimated. Level 1, Level 2 and Level 3 countries were defined as those with an active COVID-19 prevalence of up to 1/105, 10/105 and 100/105, respectively. RESULTS: With 65,272 travellers per month, the number of undetected COVID-19 infections exiting quarantine is 1 every 45, 15 and 31 months for Level 1, Level 2 and Level 3 countries, respectively. The overall rate of undetected active COVID-19 infections exiting quarantine is expected to increase from the current 0.40 to 0.50 per month, or an increase of one extra infection every 10 months. CONCLUSIONS: Loosening border restrictions results in a small increase in the rate of undetected COVID-19 infections exiting quarantine, which increases from the current baseline by one infection every 10 months. This information may be useful in guiding decision-making on selectively opening of borders in the COVID-19 era.