CRO PolandRegulatory authortiesEthics committeeClinical trials regulations


  • Poland is the largest market for clinical trials in CEE and stands for roughly 20% in terms of clinical trials number
  • The clinical trials market in Poland is still expanding, with potential for future growth. It has six key advantages, which make it attractive for clinical trial sponsors. These are:
  • Efficient patient recruitment.
  • High quality of delivered data
  • Large population of patients
  • Size and maturity of the market, experience of market stakeholders and good.

Organization of work:

  • Qualified medical staff;
  • Well-organized and specialist research sites;
  • Strong sponsor/CRO market and qualified and experienced CRAs;
  • Attractive level of clinical trial costs vis-ą-vis WE or even some CEE countries
  • Both patient participation and site penetration rates indicate a potential for growth.
  • he high regard for doctors in society translates into patients who are more compliant with study protocols and medication regime.
  • A population size of 38 million, combined with patients willingness to participate in clinical trials, make the recruitment rates significantly higher than in Western Europe or the USA.
  • Due to limited reimbursement budget, both pre-treated and treatment-nave subjects are available.
  • Patient treatment in a clinical trials is often superior to local standards of care which leads to high enrolment and patient compliance.
  • Investigators are eager and motivated to participate
  • Investigator’s fee is paid directly to study team members
  • The most often tested therapeutic areas are oncology, neurology, rheumatology, pulmonology, diabetology
  • In a survey conducted by PwC, respondents have indicated the areas in which Poland
    is the leader in the CEE region. These are: quality of medical equipment and staff, as well as high commitment of clinical research sites. According to the survey, the key competitive advantages of Poland versus EU-15 countries are still efficient patient recruitment and lower
    costs of clinical trials.

Check it

PriceWaterhouseCooper – Clinical Trials in Poland 2016 report
Report 2016

Regulatory Authorities in Poland

ClinMed provides sewrvices as a EU LEGAL REPRESENTATIVE for companies from countries outside UE. Each company that does not have their entity in European Union has to delegate its responsibilities to the EU company. More information on clinmed (at)

The initial Clinical Trial Application review process conducted by Regulatory Authority in Poland typically requires 60 days, during which the reviewers will decide if an applicant is permitted to proceed with its proposed clinical trial. Additional information may be requested from the applicant, which could extend the review period.

ClinMed submission team is also experienced in Voluntary Harmonisation Procedure (VHP) of studies submission.

Regulatory Authorities and Ethics Committee submission can be done in parallel.

All the substantial amendments are approved within 35 days

Ethics committee

EC is obliged to issue opinion for the initial Clinical Trial Application within 60 days

Regulatory Authorities and Ethics Committee submission can be done in parallel.

Substantial amendment is approved within 35 days.

Clinical trials regulations

Here are useful links regarding clinical trials in Poland

Pharmaceutical law