No longer are study sponsors required to obtain an umbrella license before a study can commence, nor is an import permit required for every shipment of drugs.
October 13, 2015 | By Mathilde (Tilly) Niessen, Distribution Project Manager, Fisher Clinical Services
Clinical trial professionals are applauding changes in regulations that make it easier and less expensive to conduct global clinical trials in Russia and Ukraine – two countries whose requirements had been provoking frustration and concern. As a follow-up to our recent webinar on this topic, let’s examine those changes and how they benefit biopharmaceutical companies evaluating new treatments and vaccines in development for our most challenging diseases, including cancers, Alzheimer’s disease and diabetes.
Russia reduces duty charges for trial drugs. Russia has long been a highly ranked location for clinical trials for a trio of reasons – from speed of recruiting and quality clinical data to the combination of low trial costs and regulatory hurdles. Eager to continue hosting clinical trials, Russia recently made it even more affordable for companies to conduct trials in the world’s largest country.
In September 2014, Russia reduced the duty on supplies of drugs imported for clinical trials. Duty charges dropped to 5.3 percent from 7.7 percent for chemically synthesized drugs, and remained at 3 percent for biological drugs. The Duty Paid Value of 10 percent must be paid in addition to the landed costs.
Ukraine eases import requirements, cuts duty charges. Ukraine – keen to align with EU standards and good clinical practices – went a step further in facilitating the importation of IMP. By significantly easing import regulations and dramatically reducing duty charges for trial drugs, Ukraine has made it easier and more affordable to bring clinical trials to this Eastern European nation.
No longer are study sponsors required to obtain an umbrella license before a study can commence, nor is an import permit required for every shipment of drugs. Now, importation of drugs can begin as soon as Ukraine’s Ministry of Health approves the clinical trial and a distributor gets the go-ahead from the Importer of Record. Submitting key paperwork is still required, of course, including the Ministry of Health’s letter of approval, a proforma invoice for each shipment, and certificates of analysis for each batch of drug to be imported.
A certificate of compliance is required only if vital information – such as drug manufacturer name and address, batch numbers and/or expiration dates – is missing from the certificate of analysis. An apostilled Power of Attorney is also necessary when a sponsor retains an external party or organization, such as a depot, to act on its behalf as Importer of Record.
These changes have reduced to two weeks the time necessary for a first drug shipment to reach Ukraine, assuming that a sponsor enlists the help of an experienced clinical supply partner to handle distribution and importation.
In addition to the time savings, sponsors are also reaping the advantages of hugely reduced duty charges in Ukraine. The import tax on drug shipments has plummeted to 12 percent from 20 percent, of which 7 percent is tax and 5 percent is a special fee.
It should also be noted that political unrest has not derailed clinical trials in Ukraine, where 77 new trials are currently recruiting patients. Having said that, sponsors are advised to avoid Luhansk and Donetsk, two eastern Ukrainian territories where there is continuing unrest. In addition, Crimea, which was recently annexed by Russia, must now be supplied by Russian offices instead of Ukrainian ones.
These changes were discussed during a recent Xtalks webinar sponsored by Fisher Clinical Services. To listen to the archived webinar, go to Clinical Trials - Russia and Ukraine - Opportunities and Challenges. You’re also welcome to email questions to me at email@example.com.
Feel free to share your opinions in the comment section below!
||Mathilde (Tilly) Niessen, Distribution Project Manager, Fisher Clinical Services
Tilly has held the role of Distribution Project Manager at Fisher Clinical Services since 2013, initially with key responsibility for the set up and management of high profile, accelerated studies for a leading pharmaceutical company.
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Keywords: Clinical Trial, Good Clinical Practice, Russia and Ukraine
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