1. Milani B, Scholten W. The world medicines situation 2011: access to controlled medicines, Department of Essential Medicines and Pharmaceutical Policies, 3rd ed. WHO, Geneva, 2011. Available: https://www.who.int/publications/i/item/WHO-EMP-MIE-2011-2.4. Accessed 25 June 2022.
2. World Health Organization (WHO), Medium-term strategic plan 2008–2013, Geneva, 2013. Available: http://apps.who.int/gb/ebwha/pdf_files/MTSP-08-13-PPB-10-11/mtsp-3en.pdf. Accessed 25 June 2022.
3. Roth L. Department of health and human services, FDA Drug Review Timeline Transparency; Statement of Policy, Federal Register, Vol. 86, No. 10, 2021.
4. Rodier C, Bujar M, McAuslane N, Liberti L, Munro J. Centre for Innovation and regulatory Science; New drug approval for six major authorities 2010-2019: Focus on Facilitated Regulatory Pathways and Internationalisation, R&D briefing 77, version 2, 2020.
5. Patel P, Cerqueira D, Santos G, Soares R, Sousa V, Liberti L, McAuslane N. A baseline analysis of regulatory review timelines for ANVISA: 2013–2016. Ther Innov Reg Sci. 2020;54:1428–35.