CHAPTER 1:
The Drug Development Continuum, Preclinical to Market Access
Regulatory Affairs Professionals Society 17
References (continued)
39. European Medicines Agency. Obtaining an EU marketing authorisation, step-
by-step. https://www.ema.europa.eu/en/human-regulatory/marketing-
authorisation/obtaining-eu-marketing-authorisation-step-step
40. European Medicines Agency. Committee for Medicinal Products for Human
Use (CHMP). https://www.ema.europa.eu/en/committees/committee-
medicinal-products-human-use-chmp
41. Food and Drug Administration. Guidance for industry: Expedited programs
for serious conditions – Drugs and biologics [Guidance document]. May 2014.
Last updated 28 November 2023. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/expedited-programs-serious-
conditions-drugs-and-biologics
42. European Medicines Agency. PRIME: Priority medicines. Last updated
2 June 2025. https://www.ema.europa.eu/en/human-regulatory/research-
development/prime-priority-medicines
43. Ministry of Health, Labour and welfare of Japan. Strategy of SAKIGAKE.
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/
140729-01.html
44. Rx Communications. An introduction to market access in the pharmaceutical
industry. First Published 1 January 2024. https://www.rxcomms.com/learning/
guide-to-market-access-in-the-pharmaceutical-industry
45. Drug Discovery Today. Nasal spray medicine for treatment-resistant
depression not recommended by NICE. 28 January 2020. http://www.
drugdiscoverytoday.com/view/47713/nasal-spray-medicine-for-treatment-
resistant-depression-not-recommended-by-nice/
46. National Institute of Health and Care Excellence. NICE disappointed
companies unwilling to offer fair price to make Enhertu available for advanced
breast cancer. 29 July 2024. https://www.nice.org.uk/news/articles/nice-
disappointed-that-companies-unwilling-to-offer-fair-price-to-the-nhs-to-
make-enhertu-available
47. CADTH Reimbursement recommendation Nusinersen (Spinraza). Last
updated August 2022. https://www.cda-amc.ca/sites/default/files/DRR/
2022/SR0713-Spinraza-Reassessment.pdf
48. CADTH Reimbursement recommendation Ebglyss (lebrikizumab). Last
updated 9 October 2024. https://www.cda-amc.ca/lebrikizumab
49. Gardiner RB, Sealey S, Edathodu A, Makku SR. The real impact of quality of
life (QoL) endpoints on market access decisions across markets – A case study
of oncology products. Value Health. 2014 17(3):PA94-A95. https://doi.org/
10.1016/j.jval.2014.03.550
50. Xiao Y, Gani R, Chen K, Chen C, Kongnakorn T. Health economics in
China: Changing pharmaceutical pricing and reimbursement. Evidence
Forum. 2019. https://www.evidera.com/wp-content/uploads/2019/10/12-
Health-Economics-in-China_Fall2019.pdf
51. Kleijnen S, et al. The impact of quality-of-life in relative effectiveness of new
anti-cancer drugs in European countries. Qual Life Res. 2017 26(9):2479-
2488. https://doi.org/10.1007/s11136-017-1574-9
52. PharmaVoice. Ask the experts: How does real world evidence ensure market
access? 1 March 2020. https://www.pharmavoice.com/news/2020-03-rwe-
experts/612296/
The Drug Development Continuum, Preclinical to Market Access
Regulatory Affairs Professionals Society 17
References (continued)
39. European Medicines Agency. Obtaining an EU marketing authorisation, step-
by-step. https://www.ema.europa.eu/en/human-regulatory/marketing-
authorisation/obtaining-eu-marketing-authorisation-step-step
40. European Medicines Agency. Committee for Medicinal Products for Human
Use (CHMP). https://www.ema.europa.eu/en/committees/committee-
medicinal-products-human-use-chmp
41. Food and Drug Administration. Guidance for industry: Expedited programs
for serious conditions – Drugs and biologics [Guidance document]. May 2014.
Last updated 28 November 2023. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/expedited-programs-serious-
conditions-drugs-and-biologics
42. European Medicines Agency. PRIME: Priority medicines. Last updated
2 June 2025. https://www.ema.europa.eu/en/human-regulatory/research-
development/prime-priority-medicines
43. Ministry of Health, Labour and welfare of Japan. Strategy of SAKIGAKE.
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/
140729-01.html
44. Rx Communications. An introduction to market access in the pharmaceutical
industry. First Published 1 January 2024. https://www.rxcomms.com/learning/
guide-to-market-access-in-the-pharmaceutical-industry
45. Drug Discovery Today. Nasal spray medicine for treatment-resistant
depression not recommended by NICE. 28 January 2020. http://www.
drugdiscoverytoday.com/view/47713/nasal-spray-medicine-for-treatment-
resistant-depression-not-recommended-by-nice/
46. National Institute of Health and Care Excellence. NICE disappointed
companies unwilling to offer fair price to make Enhertu available for advanced
breast cancer. 29 July 2024. https://www.nice.org.uk/news/articles/nice-
disappointed-that-companies-unwilling-to-offer-fair-price-to-the-nhs-to-
make-enhertu-available
47. CADTH Reimbursement recommendation Nusinersen (Spinraza). Last
updated August 2022. https://www.cda-amc.ca/sites/default/files/DRR/
2022/SR0713-Spinraza-Reassessment.pdf
48. CADTH Reimbursement recommendation Ebglyss (lebrikizumab). Last
updated 9 October 2024. https://www.cda-amc.ca/lebrikizumab
49. Gardiner RB, Sealey S, Edathodu A, Makku SR. The real impact of quality of
life (QoL) endpoints on market access decisions across markets – A case study
of oncology products. Value Health. 2014 17(3):PA94-A95. https://doi.org/
10.1016/j.jval.2014.03.550
50. Xiao Y, Gani R, Chen K, Chen C, Kongnakorn T. Health economics in
China: Changing pharmaceutical pricing and reimbursement. Evidence
Forum. 2019. https://www.evidera.com/wp-content/uploads/2019/10/12-
Health-Economics-in-China_Fall2019.pdf
51. Kleijnen S, et al. The impact of quality-of-life in relative effectiveness of new
anti-cancer drugs in European countries. Qual Life Res. 2017 26(9):2479-
2488. https://doi.org/10.1007/s11136-017-1574-9
52. PharmaVoice. Ask the experts: How does real world evidence ensure market
access? 1 March 2020. https://www.pharmavoice.com/news/2020-03-rwe-
experts/612296/