"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.
Ukraine, the eight largest European country by population, is an attractive location for sponsors conducting clinical research for a number of key reasons. Cromos Pharma has been successfully managing clinical trials in Ukraine since 2006. This article looks at just some of the benefits of locating your next study here.
Cromos Pharma is continuously developing and looking to explore new territories when it comes to clinical research. In line with this spirit of discovery, we will be shortly commencing a new project in Uzbekistan supporting a study being conducted by the Swiss Tropical and Public Health Institute.
Cromos Pharma is delighted to be taking part in the upcoming DIA Europe conference (15 – 19 March 2021) and BIO-Europe Spring (22-25 March 2021).
February 11th is International Women and Girls in Science Day. A joint UNESCO and UN-Women initiative, it aims to promote the role of #WomenInScience and to challenge some of the barriers to girls pursuing a career in science.
Are you a sponsor seeking to conduct clinical trials in the European Union but do not have a registered office in the European Economic Area? If so, in order to comply with the European Union Clinical Trial Directive, you are required to work with a Legal Representative registered in an EEA country.
Each 4th February, #WorldCancerDay aims to raise awareness of the global personal, social and economic burden of cancer. World Cancer Day was established in Paris at the first World Cancer Summit in 2000.
As 2021 begins, many countries are grappling with a renewed surge of COVID-19 infections necessitating further public health restrictions putting more pressure on health systems, societies and global economies. The task of rolling out approved vaccines is increasingly urgent. Almost 16 million doses of COVID-19 vaccines have been administered to date in 37 countries worldwide according to data compiled by Bloomberg ( updated 7 Jan 2021).
Tuesday 1 December marked World AIDS Day 2020. Although throughout this year our focus has been on the coronavirus pandemic, World AIDS Day is an opportunity to reflect on another pandemic where a virus passed from animals to humans with devastating consequences. To date 77 million people worldwide have been infected with HIV. In spite of innovative new treatments 35 million people have died from the virus.
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.