Primerjava regulatornih zahtev za pridobitev dovoljenja za promet z zdravilom v Združenih državah Amerike in izbranih drugih državah

Bistan, Katarina (avtor), Vrečer, Franc (mentor)

V magistrski nalogi smo primerjalno vrednotili regulativne zahteve za pridobitev dovoljenja za promet z zdravilom v Združenih državah Amerike (ZDA), Kanadi, Avstraliji in državah Evrazijske unije (EAEU). Proučili smo tudi ključne zahteve in izzive pri pridobivanju dovoljenja za promet z zdravilom v Evropski uniji (EU). Regulativne zahteve so ključne za zagotavljanje varnosti, učinkovitosti in kakovosti zdravil. Namen naloge je bil primerjati regulativne okvirje v različnih državah ter identificirati ključne razlike in podobnosti, s poudarkom na izzivih v EU in pristopih drugih držav za reševanje teh težav. Uporabili smo primerjalno analizo podatkov iz uradnih regulativnih dokumentov za ZDA, Kanado, Avstralijo, EAEU in EU. Analizo smo izvedli na podlagi kriterijev, kot so postopek pridobivanja dovoljenja, trajanje postopkov, zahteve glede varnosti in učinkovitosti ter posebni programi za pospešitev postopkov. V nadaljnjem poglavju smo podrobno obravnavali regulativne zahteve v izbranih državah. V ZDA vodi postopek Uprava Združenih držav Amerike za hrano in zdravila s strogimi zahtevami za klinične študije in programi za pospešitev postopkov za inovativna zdravila. Kanada ima podoben sistem, ki omogoča hitro obravnavo zdravil z visokim terapevtskim potencialom. Avstralija preko Avstralske uprave za zdravila zahteva obsežne dokaze o varnosti in učinkovitosti, EAEU pa stremi k harmonizaciji postopkov, vendar se sooča z izzivi pri implementaciji. Ugotovitve kažejo, da so regulativni postopki v vseh regijah strogi in zahtevajo obsežne dokaze o varnosti in učinkovitosti zdravil. Kljub temu se postopki in trajanje razlikujejo, pri čemer ZDA in EU izstopata s strogimi regulativnimi okviri. Zaključujemo, da primerjalna analiza regulativnih zahtev ponuja dragocen vpogled v različne pristope in izzive pri pridobivanju dovoljenj za promet z zdravili. Raziskava poudarja potrebo po nadaljnji harmonizaciji za izboljšanje učinkovitosti postopkov in dostopnosti zdravil na trgih ter predlaga nadaljnje raziskave na tem področju.

• Jezik: Slovenski jezik
• Ključne besede: zdravilo, pridobitev dovoljenja za promet z zdravili, smernice
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2024
• PID: 20.500.12556/RUL-158509
• Datum objave v RUL: 14.06.2024

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Comparison of regulatory requirements for obtaining drug marketing authorisation in the United States of America and selected other countries

Izvleček

In this master’s thesis, we comparatively evaluate the regulatory requirements for obtaining a marketing authorisation for a medicinal product in the United States of America (USA), Canada, Australia, and the countries of the Eurasian Economic Union (EAEU). We also examine the key requirements and challenges for obtaining a marketing authorisation for a medicinal product in the European Union (EU). Regulatory requirements are key to ensuring the safety, efficacy, and quality of medicinal products. The aim of this assignment was to compare the regulatory frameworks in different countries and identify key differences and similarities, focusing on the challenges in the EU and approaches taken by other countries to address these issues. We used a comparative analysis of data from official regulatory documents for the US, Canada, Australia, EAEU and the EU. The analysis was based on criteria such as the authorisation process, duration of procedures, safety and efficacy requirements, and specific programmes to speed up procedures. In the following section, we discuss in detail the regulatory requirements in selected countries. In the US, the process is led by the US Food and Drug Administration with strict requirements for clinical studies and fast-track programmes for innovative medicines. Canada has a similar system that allows for the fast-tracking of drugs with high therapeutic potential. Australia, through the Therapeutic Goods Administration, requires extensive evidence of safety and efficacy, and the EAEU is working towards harmonisation of procedures, but faces challenges in implementation. The findings show that regulatory procedures in all regions are stringent and require extensive evidence on the safety and efficacy of medicines. However, procedures and durations vary, with the US and the EU standing out with their strict regulatory frameworks. We conclude that a comparative analysis of regulatory requirements provides valuable insights into the different approaches and challenges in obtaining marketing authorisations for medicines. The study highlights the need for further harmonisation to improve the efficiency of procedures and the accessibility of medicines on the markets and suggests further research in this area.

• Ključne besede: medicinal product, marketing authorisation, guidelines