Reason why Bulgaria!

Some really good reasons to choose Bulgaria - a brief analysis of the current environment for conducting of clinical trials and performing drug regulatory activities in Bulgaria

I. Related to clinical trials

• Regulatory authorities
  • Regulations, compatible with ICH guidelines (regarding our future joining the European Union on 1st January 2007, our regulations were harmonized with the European, and the chapter “Pharmaceuticals” was closed 4 years ago – 10.06.2002);
  • The last update of the Drug Law, SG 31 from 13 of April 2007 is in compliance with the Directive 20/2001/EC and ICH guidelines;
  • Short timelines for regulatory approval of a clinical trial – up to 60 days (including LECs approvals);
  • Supportive authorities – Ministry of Health and the Bulgarian Drug Agency realize that bringing clinical trials to the country brings a number of benefits to the economy and the Bulgarian population.
  • Based on the good regulatory practice there is a great increase in the number of the performed clinical trials. (see Fig 1)
  • In 2005 and in 2006 were approved 175 applications for conducting of new clinical trials.
  • Fig 1 shows an gradualy increase in the number of clinical trials in Bulgaria ( source Annual Reports of Bulgarian Drug Agency www.bda.bg)
  • This represents a continuous increase (since year 1995) in the interest of the foreign companies in choosing Bulgaria as a place of business. (source Annual Reports of Bulgarian Drug Agency)
  • Low fees for LECs and Regulatory authorities;
• Patient recruitment
  • rapid recruitment of study participants (the subject enrolment potential is in many cases up to 10 times greater than in the West)
  • large patient populations are readily available due to the centralized healthcare system in Bulgaria (8 million population of Bulgaria and 1,2 million in Sofia-the capital of Bulgaria, where are the major specialized clinics and university hospitals);
  • patients are motivated to participate in clinical trials because of the opportunity to access effective drug therapy, the reduced treatment costs and the closer medical follow up and significantly better overall medical care;
  • high level of treatment compliance because of the exceptionally trustful patient-doctor relationship;
  • stable population, which facilitates follow-up;
• Investigators
  • high level of medical training;
  • specialized clinicians eager to participate in clinical trials due to the prestige, the professional progression and the material incentives;
  • well equipped centres with suitable facilities;
  • high quality of the obtained data;
• Monitors
  • Highly qualified and experienced;
  • Most of the Bulgarian monitors are physicians or biologists, which leads to excellent relations with the investigators and excellent quality of the data;
• Financial advantage – compared to Western Europe or the United States, the countries in Eastern Europe, especially Bulgaria offer reduced costs for investigator grants, patient reimbursement and CRO fees. In spite of the overall reductions in R and D expenditures due to the soft global economy, in Eastern Europe a strong annual growth is still forecasted, because of the beneficial climate for conducting low cost clinical trials.
• In spite of the overall reductions in R and D expenditures due to the soft global economy, in Eastern Europe a strong annual growth is still forecasted, because of the beneficial climate for conducting low cost clinical trials.

II. Related to Regulatory & Scientific Affairs

• Bulgaria is EU - Member from 01.01.07 marketing authorisation procedures like the Decentrelised - and Mutual Recognition Procedures are in place according to the Bulgarian Drug Law, Chapter three (Law on Medicinal Products in Human Medicines), published on 13 of April 2007, SG 31)
• Many Companies without affiliate in Bulgaria will be interested to be involved in such procedure as well as the maintenance of the product on the Bulgarian market.
• Many administrative documents are in Bulgarian language (Application form, SmPC, PIL)
• According to newly published Drug Law, Article 26, Paragraph 2 the MAH shall be located in the Community or in a country of the EEA. When the MAH has not affiliate in Bulgaria, a legal country representative shall be appointed. In this way it will be easier to act with a already registered and experienced legal entity with pharma experience in Bulgaria and abroad.
• For the Centralised Procedures at EMEA, the SmPC and PIL should be in Bulgarian Language. For that purpose the required documents on the Bulgarian language could be checked easier with local service for clients which do not have local affiliates.
• Pharmacovigilance activities