Author(s)

Qingqing Hou ¹, Yi Liang ¹

Affiliation(s)

¹ School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu Province, 210000, China

Corresponding Author

Yi Liang

ABSTRACT

Through the introduction and analysis of the development of advanced therapy medicinal products and the regulatory framework, pre-market approval and post-market supervision of ATMP in Europe in recent years, it is found that the classification and definition of ATMP by EMA is relatively scientific, and the regulatory framework and laws and regulations are relatively complete. It not only has strict approval procedures for listing licenses, but also has certain flexibility in the approval path, giving active industrial support to ATMPs. At the same time, the MAH has strict requirements on the post-market supervision system of ATMP, which is worth learning and learning from China.

KEYWORDS

Advanced Therapy Medicines, Regulation, Approval

CITE THIS PAPER

Qingqing Hou, Yi Liang, Overview of the Regulatory Regime for Advanced Therapy Medicinal Products in the EU. Social Medicine and Health Management (2022) Vol. 3: 49-57. DOI: http://dx.doi.org/10.23977/socmhm.2022.030109.

REFERENCES

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[3] Iglesias-Lopez C, Agustí A, Obach M, et al. Regulatory framework for advanced therapy medicinal products in Europe and United States [J]. Frontiers in pharmacology, 2019: 921.
[4] European Commission. Report form the Commission to the European Parliament and the Council. 2018, 03. 08. https://ec.europa.eu /health /sites/ health/files/files/advtherapies/2014_atmp /atmp_en.pdf.
[5] Neez E, Hwang T J, Sahoo S A, et al. European Medicines Agency’s priority medicines scheme at 2 years: an evaluation of clinical studies supporting eligible drugs [J]. Clinical Pharmacology & Therapeutics, 2020, 107(3): 541-552.
[6] Kondo H, Hata T, Ito K, et al. The current status of Sakigake designation in Japan, PRIME in the European Union, and breakthrough therapy designation in the United States [J]. Therapeutic Innovation & Regulatory Science, 2017, 51(1): 51-54.

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