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

Officially Bulgaria became an EU member on 01.01.2007. After that the legislation and the Drug Law were changed and were conformed to the EU legislation

I. Related to clinical trials

• Regulatory authorities

  The rules of Good Clinical Practice are approved by a regulation issued by the minister of health, according to the Declaration of Helsinki and is set up in an Annex of Regulation 31 of the Ministry of Health from 2007. The last update of the Drug Law, SG 31 from 13 April 2007 and last amendments SG 71 from 12 of August 2008 is in compliance with the Directive 20/2001/EC and ICH guidelines;

  The Bulgarian Drug Agency (BDA) realizes that bringing clinical trials to the country brings a number of benefits to the economy and the Bulgarian population and BDA give an approval or disapproval regarding Chapter IV of the Drug Law, Drug Law, SG 71.

  Ethic Committee for multicultural clinical trials at the Ministry of Health is established and is situated at the BDA, The opinion of the Ethic Committee for multicultural clinical trials, is valid for all centres on the territory of the Republic of Bulgaria involved in multicenter studies.

  Local Ethic committees are established at the hospitals and healthcare centers and BDA maintains and keeps a register of ethics committees.This register is published on the internet site of BDA. Only Local Ethic Committees with approved SOPs by the authority director could review and provide opinion regarding trials at the center.

• Approval procedure
  

  Short timelines for regulatory approval of a clinical trial - up to 60 days (including LECs approvals) The procedures at the ethic committee and at BDA could be carried out simultaneously or consecutively at the discretion of the contracting authority.

  Within 60 days from the date of submission of an application, the executive director of the BDA: issues authorisation for the conduct of the clinical trial, or issues a motivated refusal. There is an option for silent approval (non-interventional trials) - the clinical trial can be started provided that within the time limit, BDA has not issued a notification with motives of disapproval of the clinical trial.

  Within 60 days from the submission of an application, the Ethics Committee passes a resolution with an opinion, which is sent to the applicant and BDA.

  • Based on the good regulatory practice there is a great increase in the number of the performed clinical trials in the period 1995 -2009.
  • The comparatively law fees (compared to the old EU members states) for LECs and Regulatory authorities are also one of the reasons Bulgaria to be involved in several trials.

• Patient recruitment
  
  
  • Rapid recruitment of study participants (the subject enrolment potential is in many cases greater than in the West)
  • Growth potential is significant in East EU, because of the low number of the study sites per million population?;
  • Study sites in East EU countries are presently concentrated in a few key cities and there is opportunity for expansion into smaller cities?;
  • Large patient populations are readily available due to the centralized healthcare system in Bulgaria (7,6 million population of Bulgaria and 1,4 million in Sofia-the capital of Bulgaria, where are the major specialized clinics and university hospitals);
  • There are 476 sites in Bulgaria, where 199 sites are located in Sofia (41,8 %) and Sofia is in the 500 world most active trial cities?;
  • 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
  

  The Bulgarian investigators are appropriately qualified by education, training and experience. They are ICH GCP experienced, English speaking, highly motivated and delivering a very high quality of data. They demonstrate that they have at their disposal:

  • Appropriate staff;
  • Appropriate facilities;
  • Enough time;

• Monitors
  
  • Highly qualified and experienced;
  • Most of the Bulgarian monitors are physicians, pharmacists, biologists or nurses, 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 & 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 an EU member since 01.01.07. Marketing authorisations - Decentralised 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)
• 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 should be translated into Bulgarian language (Application form, SmPC, PIL)
• According to published Drug Law in 2007, Article 26, Paragraph 2 the MAH (marketing authorization holder) shall be located in the Community or in a country of the EEA. When the MAH has not got an affiliate in Bulgaria, a legal country representative shall be appointed. In this way it will be easier to act with a company with pharma experience in Bulgaria.
• For the Centralised Procedures at EMEA, the SmPC and PIL should be translated into 23 EU languages, including the Bulgarian language. For this reason the required documents in Bulgarian could be easier proceeded with local support.
• Pharmacovigilance activities - the postmarketing surveillance is part of the maintenance of the medicinal product on the market and all local information about certain product should be collected and recorded.