WHO meeting with Russian Federation influenza centre

On 10 September 2009, WHO experts met Dr Oleg Kiselev, Director the WHO national influenza centre, the Research Institute on Influenza of the Russian Academy of Medical Sciences, to discuss recommendations for trials and prospects for the international registration of new pharmaceutical products (interferons) that were developed in the Russian Federation and could be used in the prevention and treatment of respiratory virus infections, including pandemic influenza. The products have already been evaluated and authorized for use in the Russian Federation. 



The Russian representative described the promising results of preliminary testing of the new products. They have undergone two phases of trials: those in which scientists seek to determine the toxicity levels of the drugs and to measure their therapeutic benefits. 



The WHO experts emphasized the need for the Russian Federation to ensure that products continue to undergo appropriate clinical studies, and provide product quality assurance to seek regulatory approval at the international level. The need, on side of the Russian Federation, to complete the necessary authorization procedure so as to facilitate wider access, was stressed at the meeting. WHO’s position on the international use of medicines was restated: once the process of product quality assurance is completed, the new product, as required by the prequalification process, must then go though a phase-3 clinical trial programme in order to be approved as suitable for international registration.

The early results of the ongoing clinical trials and issues related to possible international registration of medicines from the Russian Federation would be brought up at the WHO clinical consultation to be held in October in Washington DC, United States of America and the research agenda meetings that will take place in November in Geneva, Switzerland. 



WHO experts at the meeting included Dr Charles Penn, Scientist, Global Influenza Programme at WHO headquarters, and staff of WHO/Europe’s Communicable Diseases unit: Dr Nedret Emiroglu, Unit Head; Dr David Mercer, Technical Officer; and Dr Olexandr Polishchuk, Technical Officer.