International – WHO charts path to convergence on cell and gene therapies
More info under: https://www.ris.world/international-who-charts-path-to-convergence-on-cell-and-gene-therapies/
More info under: https://www.ris.world/international-who-charts-path-to-convergence-on-cell-and-gene-therapies/
Read RIS-WORLD press release: https://www.ris.world/europe-reflection-paper-on-good-manufacturing-practice-and-marketing-authorisation-holders/ Read the EMA’s Reflection Paper: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-good-manufacturing-practice-marketing-authorisation-holders_en.pdf
NICE also aims to make strides in digital, genomic and antimicrobial technologies Read the full press release: https://www.ris.world/uk-nice-moves-increased-accessibility-and-flexibility-for-health-tech/
It is recommended that a risk assessment is undertaken for all clinical trials. Identification of potential risks to trial participants and to the reliability of the trial results on a trial basis and taking actions...
The NHS has struck a deal for a life-saving treatment, reportedly the most expensive drug in the world, that will offer babies and young children with a rare and fatal genetic disease the prospect of...
Read more under https://www.ris.world/uk-not-so-nice-cancer-patients-miss-out-on-innovative-new-treatments/
Read more on https://www.ris.world/europe-regulation-on-emas-extended-mandate-becomes-applicable/
Après presque quatre années de négociations, le Règlement sur l’évaluation des technologies de la santé (ETS) a été adopté et publié au JOUE le 22 décembre 2021. Il s’appliquera à partir du 12 janvier 2025....
The National Institute for Health and Care Excellence (NICE) has published its conclusions to its review of its methods and processes for Health Technology Assessments. Read the full response from the BioIndustry Association
Healthcare in Canada has been identified as being fragmented, and obtaining Market Access is cumbersome and lengthy. Rare diseases are a complex issue but account for a large amount of healthcare spending. Currently there is...
Introduced in 2014, EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines when there is a clear unmet need. The scheme is voluntary and does not replace the normal licensing...