ROCKVILLE, Md., Oct. 11 /PRNewswire/ -- Russia’s unique regulations on health product development have cost the nation millions of dollars. Since the demise of the Soviet Union, the world’s 7th most populated nation has remained isolated from marketing its pharmaceutical and medical device discoveries outside its own borders. To its fiscal detriment, Russia’s existing regulations are not compatible with the requirements of most countries. But through the recent efforts of the BioIndustry Initiative (BII), the Regulatory Affairs Professionals Society (RAPS), in conjunction with the US State Department, is helping Russia become a known healthcare research entity.
In order to build a bridge between Russian science and the global community, the US government has sought the expertise of RAPS in establishing standards for Russian research facilities and scientific organizations. Working in collaboration with Russian authorities, RAPS is helping the country’s leading scientists harmonize their regulatory processes with those of the international community-opening a multimillion dollar market potential and the possibility of “undiscovered” therapeutics.
Zorina Pitkin, PhD, RAC, a native of Russia and a member of RAPS’ advisory committee for the project, likens the problem of regulatory incompatibility to differences in electrical voltages across international borders. “If you’re from the US and you bring a laptop computer to Europe, the voltage difference will render your laptop useless. But if you have an adaptor, you can make it work.”
Similarly, if a healthcare company follows a set of regulations that satisfies the requirements of multiple countries, they can leverage their research or products for the benefit of many.
RAPS’ mission to help establish harmonized regulations in Russia is a component of BII -- an effort that aims to reduce terrorists’ access to biological weapons and facilities, and joins Russia in combating terrorism. To achieve these goals, the State Department is helping to transform former Soviet biological production facilities into channels for sustainable peaceful applications, and is partnering with Russian scientists to develop drugs and vaccines for highly infectious diseases that affect both the former Soviet Union and the world.
“RAPS brings critical expertise and a global scope to the BioIndustry Initiative and our efforts to provide the Russian scientific community with international reach in marketing its discoveries,” said Dr. Jason Rao, Director of the BioIndustry Initiative.
To this end, members of RAPS’ advisory committee recently made a trip to Moscow to evaluate Russia’s current regulatory environment. Using that acquired knowledge, the committee is now working with members of the Russian scientific community to examine ways to enhance the compatibility of Russian regulations and thus the marketability of Russian health products.
Central to RAPS’ efforts is the advancement of good laboratory practice (GLP) in Russia. GLP is the model through which laboratory testing is carried out in a controlled, precise manner. GLP is a critical element of international health product regulation. Without adhering to it, a company’s drugs and medical devices cannot pass the scrutiny of international governments.
“There is a sincere willingness from the Russian scientists to learn good laboratory practice,” explained Pitkin. “There is also a strong demand from the Russian government to implement it. There’s work to do, but the willingness is there.”
According to RAPS Executive Director Sherry Keramidas, PhD, CAE, “This program demonstrates the great import of regulatory compliance in every setting, every nation. It’s our goal to provide the knowledge and tools to reach these goals ... to enable Russia to compete on an equal playing field with scientists around the globe.
Regulatory Affairs Professionals Society
CONTACT: Patrick Bernat, Program Manager, Communications & PR,Regulatory Affairs Professionals Society, +1-301-770-2920, ext. 245,pbernat@raps.org
Web site: http://www.raps.org/
