Regulatory status and marketing history of Ukrain

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Details of regulatory status and marketing history in non EU countries. NSC 631570 is manufactured from two already approved drugs – Thio-TEPA (USP XXII) and greater celandine alkaloids extract (DAB 10). European Patent No. 0083600, US Patent No. 2,670,347. NSC 631570 has anticancer action and is about 300 times less toxic than Thio-TEPA. Therefore an application for registration of NSC 631570 in Austria was first made in 1976 as a second-line therapy after all conventional treatment modalities had failed. Further in vitro, in vivo, and clinical studies have given a lot of evidence for the anticancer effect of NSC 631570. This was the reason to make a second application in 1986 for registration in Austria for treatment of adenocarcinomas, especially in the colorectal area, mammary, bladder, prostate, ovary, cervix, endometrium, plate epithelial carcinomas, small cell and non-small cell lung cancer, tumours in the head-neck area, testicle carcinomas, sarcomas, malignant melanomas and lymphomas. Similar applications were made in other countries where later NSC 631570 was approved: Belarus (White Russia, 8.1.1995, reg. #1330/95), Ukraine (15.10.1998 and 3.9.2003, reg. #3641), Georgia (5.8.1999, reg. #002861), Turkmenistan (13.4.2000, reg. #0001707), Azerbaijan Republic (5.9.2000, reg. #00267), and Tadshikistan (7.9.2000, reg. #000568) (Information for physicians in Ukrainian and English). 19 years after the application for NSC 631570 was made in Austria, the former Ministry of Health and Customer Protection with the settlement on 2.6.1995 refused my registration application at first time. I have taken the only legal remedy available for me and made a complaint against this settlement to the Supreme Administrative Court. The Supreme Administrative Court granted my appeal with the judgement on 26.2.1996, cancelled the contested settlement because of wrongfulness due to the procedure regulation violation, and ordered the procedure completion. Approximately six years after the cancelling judgement of the Supreme Administrative Court, the next negative settlement was issued on 25.4.2002, which I countered with a complaint on 7.6.2002. Recently, Ukrain has got the orphan drug status for the treatment of pancreatic cancer in Australia (Decision of Therapeutic Goods Administration, Department of Health and Ageing, Australian Government from 8.6.2004) and in the United States of America (Decision of the Office of Orphan Products Development (HF-35), Food and Drug Administration from 20.08.2003, for both documents see Bibliography).