COMPARISON OF DRUG DELAYS FOR NEW DRUGS APPROVED IN TÜRKİYE WITH INTERNATIONAL AUTHORITIES

Öz

Objective: The pharmaceutical industry is constantly increasing in importance due to the ever-increasing need for health services, rising living standards, increasing average life expectancy, and advances in health technology. The approval of a new drug in the world varies from country to country. There may be differences in the time delay in the release of an approved drug to the free market or the number of quantities in the total number of approved drugs between countries. Therefore, when the drugs are introduced to the market or allowed to be commercialized by the health authorities of the countries is of great importance.

Material and Method: The research is a comparison of drug delays between the years between 2015-2024; the drugs approved by the Turkish Medicines and Medical Devices Agency (TITCK) and the health authorities of the US, Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japan, Pharmaceuticals and Medical Devices Agency (PMDA), and the Canadian Drug Agency (CDA).

Result and Discussion: The results obtained in the research show that there are absolute and relative drug delays in Türkiye. In addition, it is seen that the average number of days of drug delays in Türkiye is higher than FDA, EMA, CDA and PMDA. Türkiye experiences an average number of drug delays ranging from 298 to 1679 days. This also means that patients in Türkiye have a later access to drugs compared to other countries.

Anahtar Kelimeler

• Drug access
• drug approval
• drug delay
• new molecule drugs

TÜRKİYE'DE ONAYLANAN YENİ İLAÇLARIN İLAÇ GECİKME SÜRELERİNİN ULUSLARARASI OTORİTELERLE KARŞILAŞTIRILMASI

Öz

Amaç: Sağlık hizmetlerine olan ihtiyacın giderek artması, yaşam standartlarının yükselmesi, ortalama yaşam süresinin artması ve sağlık teknolojisindeki gelişmeler nedeniyle ilaç endüstrisi sürekli olarak önem kazanmaktadır. Dünyada yeni bir ilacın onayı ülkeden ülkeye değişmektedir. Onaylanmış bir ilacın serbest piyasaya sürülmesindeki gecikme süresinde veya ülkeler arasında onaylanmış toplam ilaç sayısındaki miktar sayısında farklılıklar olabilir. Bu nedenle, ilaçların piyasaya sunulduğu veya ülkelerin sağlık otoriteleri tarafından ticarileştirilmesine izin verildiği zaman büyük önem taşımaktadır.

Gereç ve Yöntem: Araştırma, 2015-2024 yılları arasındaki ilaç gecikmelerinin; Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) tarafından onaylanan ilaçlar ile ABD, Gıda ve İlaç Dairesi (FDA), Avrupa İlaç Ajansı (EMA), Japonya İlaç ve Tıbbi Cihaz Kurumu (PMDA) ve Kanada İlaç Ajansı (CDA) sağlık otoriteleri tarafından onaylanan ilaçlar arasındaki karşılaştırmasıdır.

Sonuç ve Tartışma: Araştırmada elde edilen sonuçlar Türkiye'de mutlak ve göreceli ilaç gecikmelerinin olduğunu göstermektedir. Ayrıca, Türkiye'de ilaç gecikmelerinin ortalama gün sayısının FDA, EMA, CDA ve PMDA'dan daha yüksek olduğu görülmektedir. Türkiye, 298 ila 1679 gün arasında değişen ortalama ilaç gecikmesi sayısı yaşamaktadır. Bu aynı zamanda Türkiye'deki hastaların diğer ülkelere kıyasla ilaçlara daha geç eriştiği anlamına gelmektedir.

Anahtar Kelimeler

• İlaç erişimi
• ilaç gecikmesi
• ilaç onayı
• yeni molekül ilaçlar

Kaynakça

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