Poland

About

CRO in Poland, cultural insight, market overview, medical system, and more

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clinical trial participants each year

potential clinical trial sites

days average contract to FPI

worldwide registration volume

GCT in Poland

Country manager

Daria Podgorska

MD, PhD, MBA

Office information

Tel: +48 22 6170042

Fax: +48 22 6160001

Email: bd@gctrials.com

Mlądzka 10, 04-136 Warsaw, Poland

Country manager

Daria Podgorska

MD, PhD, MBA

Office information

Tel: +48 22 6170042

Fax: +48 22 6160001

Email: bd@gctrials.com

Mlądzka 10, 04-136 Warsaw, Poland

On map

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Regulatory

Poland is located in Central Europe, has population of 37.9 million people and is the fifth-most populous member state of the European Union. Poland remains to be one of the largest clinical trial markets in CEE, having a share close to 20% in terms of the number of clinical trials held.

An EU member since 2004, Poland has its medical and pharmaceutical legislation harmonized with the EU. The typical timeline for receiving authorization from the regulatory authorities to conduct medicinal or device trials is 60 days.

Similarly to other countries within the EU, Poland requires Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approvals before the drug or device trial can start.

Regulatory Agency/Competent Authority (RA) approval

The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its representative. To apply for the trial approval in the EU, sponsor who do not have a registered office within the territory of the EEA has to assign EU legal representative to act as primary contact for the Authorities on behalf of the Sponsor.

Official links

https://www.gov.pl/web/zdrowie/

Regulatory approval for clinical trials in Poland

Pharmaceutical Industry & Clinical Trials Market

The clinical trials market in Poland is well organized, mature, and presents a valuable and acknowledged potential. Clinical trials enrollment in Poland is typically faster than in many other countries. This is due to a large population and specialized medical centers located around main cities. There are more and more new centers that specialize only in clinical trials. The investigators and site staff are highly qualified and interested in participation, as this creates opportunities for hands-on testing of new treatments, scientific knowledge exchange, publications co-authoring, and financial benefits. The investigators are familiar with ICH-GCP, modern treatment standards and experienced in clinical trials, capable of delivering high-quality data.

Another key driving force for the domestic clinical trials’ market is the population size of 38 million. The country can facilitate an average of 40,000 patients a year taking part in clinical trials.

The Polish pharmaceutical industry is projected to record a steady compound annual growth rate of 3.2%, according to a report by Global Data. The report forecasts the industry to grow from $9.4bn last year to $11bn by 2021.

Medical System in Poland

Health care in Poland is delivered through a publicly funded health care system, but the private sector is steadily growing as well. Every person of working age pays a compulsory insurance fee of approximately 9% of their income, which goes to the National Health Fund (NFZ). At the same time, it is sufficient for one family member to have the insurance, which is automatically applied to everyone else in the family. Retirees receive health insurance for free, students are provided with one by their universities, and the unemployed are provided by the local labor departments.