Komparativna studija regulatornih okvira za registraciju lekova u Evropskoj uniji i Sjedinjenim Državama

  • Blagoj Gjeorgiev Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Dijana Miceva Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Dino Karpicarov Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Paulina Apostolova Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Krume Bogevski Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Marija Arev Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
  • Biljana Gjorgjeska Univerzitet "Goce Delčev", Fakultet medicinskih nauka, Štip, Severna Makedonija
DOI: https://doi.org/10.5937/arhfarm75-55555
Ključne reči: harmonizacija, regulisanje, ovlašćenje, evaluacija

Sažetak


Registracija leka se odnosi na procenu bezbednosti, efikasnosti i kvaliteta medicinskog proizvoda, što dovodi do davanja dozvole za stavljanje u promet. S obzirom na intenzivnu globalizaciju farmaceutske industrije, harmonizacija regulatornih procedura između Evropske agencije za lekove (EMA) i Uprave za hranu i lekove Sjedinjenih Država (FDA) je ključna za ubrzanje dostupnosti novih lekova. EMA sprovodi tri različite procedure za registraciju lekova: centralizovanu, decentralizovanu i proceduru uzajamnog priznavanja. Nasuprot tome, FDA nudi tri vrste registracionih prijava: prijavu za novi lek u toku istraživanja, prijavu za novi lek i prijavu za novi lek sa skraćenim postupkom. Poređenje između FDA i EMA otkriva brojne razlike unutar svakog sistema i naglašava mogućnosti za harmonizaciju. Dok obe agencije postižu visoku usklađenost u svojim konačnim odlukama, FDA je brža i efikasnija, ima koristi od centralizovane vlasti i ubrzanih postupaka. Strukturirani pristup EMA-e obezbeđuje temeljne procene, ali može da odloži odobrenja. Napori za harmonizaciju, kao što su FDA-EMA program paralelnih naučnih saveta i Sporazum o međusobnom priznavanju, imaju za cilj da poboljšaju usklađivanje i smanje razvojne resurse, stvarajući globalno regulatorno okruženje za pojednostavljenje registracije novih lekova.

Reference

Aronson JK, Ferner RE. Unlicensed and off‐label uses of medicines: definitions and clarification of terminology. Br J Clin Pharmacol. 2017;83(12):2615–25.

Sifuentes MM, Giuffrida A. Drug Review Differences across the United States and the European Union. Pharm Regul Aff: Open Access. 2015;4(4):1000e156.

Van Norman GA. Drugs and Devices: Comparison of European and U.S. Approval Processes. JACC Basic Transl Sci. 2016;1(5):399–412.

Authorizations of Medicines – European Medicines Agency [Internet]. European Medicines Agency [cited 2025 Mar 20]. Available from: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines.

European Commission. EudraLex – Volume 2 – Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use [Internet]. health.ec.europa.eu; 2019 [cited 2025 Mar 20]. Available from: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-2_en.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Internet]. Official Journal of the European Union. 2004;L 136(47):1–33 [cited 2025 Mar 20]. Available from: https://eur-lex.europa.eu/eli/reg/2004/726/oj.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Internet]. Official Journal of the European Communities. 2001;L 311(44):67–128 [cited 2025 Mar 20]. Available from: https://eur-lex.europa.eu/eli/dir/2001/83/oj.

Ghalamkarpour A. Marketing Authorization Procedures in the European Union – Making the Right Choice. Life Science Technical Bulletin. 2009;33:1–5.

Young E. Evaluation of the European Medicines Agency – Final report [Internet]. 2010 [cited 2025 Mar 20]. Available from: https://health.ec.europa.eu/.

Van Norman GA. Drugs, Devices, and the FDA: Part 1. JACC Basic Transl Sci. 2016;1(3):170–9.

National competent authorities (human) – European Medicines Agency [Internet]. European Medicines Agency [cited 2025 Mar 20]. Available from: https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human.

Kekare A, Jagadish PC, Janodia M, Bhat K, Karande S, Udupa N. Drug product registration and marketing authorization procedures in EU – A perspective. Marmara Pharm J. 2013;1(17):1–6.

How Drugs are Developed and Approved [Internet]. U.S. Food and Drug Administration; 2019 [cited 2025 Mar 20]. Available from: https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved.

Ciociola AA, Cohen LB, Kulkarni P, Kefalas C, Buchman A, Burke C, et al. How Drugs are Developed and Approved by the FDA: Current Process and Future Directions. Am J Gastroenterol. 2014;109(5):620–3.

Kashyap UN, Gupta V, Raghunandan HV. Comparison of Drug Approval Process in United States & Europe. J Pharm Sci Res. 2013;5(6):131–6.

Investigational New Drug (IND) Application [Internet]. U.S. Food and Drug Administration; 2022 [cited 2025 Mar 20]. Available from: https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.

New Drug Application (NDA) [Internet]. U.S. Food and Drug Administration; 2022 [cited 2025 Mar 20]. Available from: https://www.fda.gov/drugs/types-applications/new-drug-application-nda.

Mahapatra AK, Sameeraja NH, Murthy PN. Drug Approval Process – In United States of America, European Union and India: A Review. Appl Clin Res Clin Trials Regul Aff. 2014;1(1):13–22.

Rafi N, Sandeep DS, Narayanan VA. Regulatory Requirements and Registration Procedure for Generic Drugs in USA. Indian J Pharm Educ Res. 2018;52(4):544–9.

Navale SA, Basarkar GD. Overview of Drug Approval Process and Post Approval Changes in Europe. Int J Drug Regul Aff. 2023 Dec 15;11(4):1–15.

Parvizi N, Woods K. Regulation of medicines and medical devices: contrast and similarities. Clin Med. 2014;14:6–12.

Marathe DD, Shahzeb SM. Review on: Dossier submission in the European countries by using mutual recognition procedure and decentralized procedure. J Generic Med. 2022;19(1):4–9.

Sambhaji DJ, Tidke PB. Review on “Regulatory Approval Process of INDA, NDA and Anda in India and Foreign Countries (Us, Europe, China, Australia, Canada).” Int J Innov Sci Res Technol. 2024;9(3):545–60.

Kühler TC, Bujar M, McAuslane N, Liberti L. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016. BMJ Open. 2019;9(11):e028677.

DiMasi JA, Wilkinson M. The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing. Ther Innov Regul Sci. 2020;54(6):1453–60.

Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. N Engl J Med. 2012;366(24):2284–93.

Vokinger KN, Serra-Burriel M, Glaus CEG, Rohr UP, Hwang TJ, Dalla S, et al. Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020. Ann Intern Med. 2023;176(10):1413–8.

Kashoki M, Hanaizi Z, Yordanova S, Veselý R, Bouygues C, Linares J, et al. Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why. Clin Pharmacol Ther. 2019;107(1):195–202.

Zerhouni E, Hamburg M. The need for global regulatory harmonization: A public health imperative. Sci Transl Med. 2016;8(338):338ed6.

Hanaizi Z, Kweder S, Thor S, Ribeiro S, Marcal A. Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations. Ther Innov Regul Sci. 2022;57:321–8.

Thor S, Vetter T, Marcal A, Kweder S. EMA‑FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age. Ther Innov Regul Sci. 2023;57:656–61.

Ernesto LG, Loureiro RM. Pharmaceutical Manufacturing in the EU and the EU-US Mutual Recognition Agreement. PDA J Pharm Sci Technol. 2020;74(6):617–26.

Frequently Asked Questions and Answers – U.S.-EU Mutual Recognition Agreement [Internet]. U.S. Food and Drug Administration; 2023 [cited 2025 Mar 20]. Available from: https://www.fda.gov/media/168700/download?attachment.

European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines – European Medicines Agency [Internet]. European Medicines Agency [cited 2025 Mar 20]. Available from: https://www.ema.europa.eu/en/news/european-commission-ema-fda-agree-new-priorities-strengthen-their-collaboration-medicines

Objavljeno
2025/04/26
Broj časopisa
Vol. 75 Br. Notebook 2 (2025): Arhiv za farmaciju
Rubrika
Pregledni (Revijalni) rad
Autori koji objavljuju u ovom časopisu pristaju na sledeće uslove:

  1. Autori zadržavaju autorska prava i pružaju časopisu pravo prvog objavljivanja rada i licenciraju ga "Creative Commons Attribution licencom" koja omogućava drugima da dele rad, uz uslov navođenja autorstva i izvornog objavljivanja u ovom časopisu.

  2. Autori mogu izraditi zasebne, ugovorne aranžmane za neekskluzivnu distribuciju članka objavljenog u časopisu (npr. postavljanje u institucionalni repozitorijum ili objavljivanje u knjizi), uz navođenje da je članak izvorno objavljen u ovom časopisu.

  3. Autorima je dozvoljeno i podstiču se da postave objavljeni članak onlajn (npr. u institucionalni repozitorijum ili na svoju internet stranicu) pre ili tokom postupka prijave rukopisa, s obzirom da takav postupak može voditi produktivnoj razmeni ideja i ranijoj i većoj citiranosti objavljenog članka (Vidi Efekti otvorenog pristupa).