Revista Farmabiotec 22

#22 farmaBIOTEC 85 estándares de seguridad que caracterizan al modelo euro - peo. La colaboración continua entre reguladores, desarro - lladores y clínicos seguirá siendo esencial para convertir el potencial científico en realidades terapéuticas accesibles. Bibliografía • [1] https://www.ema.europa.eu/en/human-regulatory-over- view/advanced-therapy-medicinal-products-overview. • [2] https://www.ema.europa.eu/en/human- r e g u l a t o r y - o v e r v i e w / ma r k e t i n g - a u t h o r i s a t i o n / advanced-therapies-marketing-authorisation. • [3] Directiva 2001/83/CE. • [4] Reglamento (CE) 726/2004. • [5] https://www.ema.europa.eu/en/human-regulatory- overview/advanced-therapy-medicinal-products-overview/ legal-framework-advanced-therapies. • [6] https://www.ema.europa.eu/en/human- r e g u l a t o r y - o v e r v i e w / ma r k e t i n g - a u t h o r i s a t i o n / advanced-therapies-marketing-authorisation. • [7] Reglamento (CE) 507/2006. • [8] Reglamento (CE) 726/2004. • [9] https://www.ema.europa.eu/en/news/first-car-t-cell-medi - cine-mantle-cell-lymphoma#:~:text=EMA%20has%20recom- mended%20granting%20a%20conditional%20marketing%20 authorisation,after%20two%20or%20more%20lines%20of%20 systemic%20therapy. • [10] https://www.ema.europa.eu/en/human-regula- tory-overview/marketing-authorisation/conditional-mar- ket ing-author isat ion#:~: text=EMA%27s%20CHMP%20 may%20grant%20a%20condi t ional%20market ing%20 authorisation,the%20fact%20that%20additional%20data%20 are%20still%20required. • [11] Reglamento (EC) 726/2004. • [12] https://www.ema.europa.eu/en/human-regulatory-over- view/marketing-authorisation/pre-authorisation-guidance#1- types-of-applications-and-applicants-6893. • [13] Reglamento (CE) 507/2006. • [14] RD 1345/2007. • [15] https://www.ema.europa.eu/en/glossary-terms/ decentralised-procedure • [16] Regulation (EC) 726/2004 • [17] https://www.ema.europa.eu/en/human- r e g u l a t o r y - o v e r v i e w / r e s e a r c h - d e v e l o p m e n t / compassionate-use • [18] Balasubramanian G, Morampudi S, et al. An overview of Compassionate Use Programs in the European Union member states; Intractable Rare Dis Res.; 2016 Nov;5(4):244-254. • [19] RD 1015/2009 • [20] Reglamento (CE) 1394/2007 • [21] RD 477/2014 • [22] Hills, Allison et al.; An assessment of the hospital exemp - tion landscape across European Member States: regulatory fra- meworks, use and impact; Cytotherapy; Volume 22, Issue 12, 772 – 779. • [23] Reglamento (CE) 1394/2007 Normativa y regulación