Module 6

04 October 2024

References (1)

• Pignatti F, et al (2002). The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome. Eur J Clin Pharmacol. • Regnstrom J, et al (2009). Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol. • Putzeist M, et al (2012). Factors influencing non-approval of new drugs in Europe. Nat Rev Drug Discov. • PRIME: 5 years experience, March 2016- June 2021. European Medicines Agency • Victoria Palmi , (July 2017). Accelerated Assessment (AA) Review of 10 months experience with the new AA process • Hofer MP, et al (2018). Marketing authorisation of orphan medicines in Europe from 2000 to 2013, Drug Discov Today. • Amaouche N, et al (2018) . Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises : an analysis of major objections and their impact on outcomes. Drug Discov Today. • Bakker E, et al (2022). Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020. Clin Pharmacol Ther. • Tesileanu CMS, et al (2023). Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5-Year Retrospective Analysis. Clin Pharmacol Ther. • Uster DW, et al (2024) . Insights into Early Interactions on Innovative Developments with European Regulators. Ther Innov Regul Sci.

Classified as public by the European Medicines Agency

54

References (2)

• European Medicines Agency Guidance for applicants seeking access to PRIME scheme, September 2023

• A guideline on changing the classification for supply of medicinal product for human use, January 2006

• A guidance on a new therapeutic indication for a well established substance, November 2007

• A guidance on elements to support significant clinical benefit in comparison with existing therapies of a new therapeutic indication for 11 year marketing protection, November 2007 • Guideline on scientific application and practical arrangement for conditional marketing authorization , February 2016 • Reflection paper on chemical structure properties to be qualify as new active substance, December 2015 • Guideline on procedures for granting the marketing authorisation under exceptional circumstances, December 2005 • Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances | European Medicines Agency

(EMA) (europa.eu), draft November 2022

• Pre-authorisation guidance | European Medicines Agency (EMA) (europa.eu), last update 21 June 2024

• Procedure advice on re-examination of CHMP opinions, February 2009

• Accelerated assessment | European Medicines Agency (EMA) (europa.eu)

Assessment template Rev 10 23, , October 2023

•

Classified as public by the European Medicines Agency

55

28