"Russia's process of medicinal product registration has become very complicated," said Dr. Vladimir Bogin, CEO of Cromos Pharma. "It is extremely difficult for foreign manufacturers to navigate through a very complex application process, especially in view of confusing and sometime conflicting laws and regulations. There has been a change in agencies responsible for registration, the guidelines keep shifting and application times have become unpredictable."
In 2010 the Russian government passed legislation that requires all new drug entities seeking approval in Russia to have at least part of phase I-III multicenter clinical trials conducted locally. If the manufacturer does not fulfill this requirement, then a registration trial will need to be repeated in Russia. Also, the new "2020 initiative," devised by central and local government and aimed to improve the competitiveness of the domestic pharmaceutical industry, set very high goals of increasing domestic products' share to 50%. These changes will continue to make market entry of foreign products more challenging.
"Foreign manufacturers are now faced with the dilemma -- do they abandon the thought of registering new products in Russia or do they proceed with the understanding that this process is flawed with unexpected pitfalls and delays. As Russian market of pharmaceutical sales keeps growing exponentially, the former is not really an option," continued Dr. Bogin. "You need a reliable local partner to be successful."
Cromos™ Pharma has vast experience in successfully working with regulatory agencies on granting registration approvals and a deep understanding of the ongoing changes in this field.
Cromos™ Pharma is a full service CRO and a sourcing vendor that prides itself on very high quality of work, full GCP compliance and some of the brightest minds in the business. It helps its clients to navigate through all stages of clinical trial process -- starting from drafting of study protocol through regulatory support and all the way to final study report and statistical analysis. Cromos™ Pharma provides services to both foreign and domestic Pharma since 2005 and is a privately owned company.
If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.