4. Regulatory Authority (RA)/ Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

As per Art 10 of the Act of March 2023, the documents required for submission are in accordance with the EU CTR 536/2014.

The EU Regulation 536/2014 specifies that the documents to be evaluated are divided into two sections:

• Part 1 (including protocol and investigator information, benefit-risk assessment; see Article 6)
• Part 2 (including requirements for consent; recruitment; suitability of the trial site as well as persons involved in the conduct; data protection; insurance; and handling of biomaterials; see Article 7)

Those are submitted via the CTIS portal (the EU’s Clinical Trials Information System):

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

The timelines are set out in the table below, based on Art 5 (Application), Art 6 (Assessment report – aspects covered by Part I) & Art 7 (Assessment report – aspects covered by Part II), of the EU CTR 536/2014:

• In red: Time for sponsor to respond to questions (RFIs).
• In green: Time for RMS or MSC to assess and discuss responses.
• RMS: Reporting Member State
• MSC: Member State Concerned

If the response to the RFI is not submitted within the timeframe provided, the application will lapse.

4.3 Does the regulation support electronic submission?

Yes. All documents are to be submitted electronically through the EMA CTIS portal.

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

No, submission of clinical trials as per EU CTR 536/2014 can be done by the Sponsor or authorized representative.

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

A Clinical Trial Application needs to be made through the EMA CTIS portal. The CTIS Sponsor Handbook is helpful in this regard.

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

Yes, the reporting Member State provides a written acknowledgment (via the CTIS portal) of the submitted application within 6 days of submission of the application.

Art 5.1, Clinical Trial Regulation (EU) 536/2014. 

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

There are two sets of fees applicable, one to the URPL for the review of the clinical trial and another fee to the Compensation Fund.

Art 58 (1) of the Act of March 2023 sets forth the fees for the review of clinical trials under the EU CTR 536/2014.

Art 58 (1)

“A fee shall be payable, insofar as the implementation of the provisions of EU CTR 536/2014 is concerned, for the submission of an application for a permit:

1) a commercial clinical trial of phases I-III, where the Republic of Poland acts as rapporteur;

2) commercial clinical trial of phase I-III, where the Republic of Poland does not act as rapporteur;

3) a commercial phase I-III clinical trial under Article 14 of Regulation 536/2014;

4) a phase IV clinical trial, where the Republic of Poland acts as rapporteur…”.

The fees vary between approximately USD5-7,000, depending on whether the clinical trial is Phase I-IV, and have to be divided between and paid into two separate bank accounts – one for the Medical Research Agency and one to URPL/the Office, as follows:

Art 58(2) provides that:

“[t]he fee shall be:

1) PLN 30,000 [approximately USD7,000 at current rates] for submission of the application referred to in paragraph 1 item 1, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account;

2) PLN 25,000 [approximately USD5,750 at current rates] for submitting the application referred to in paragraph 1 items 2, 3, and 4, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account;

3) PLN 21,000 [approximately USD4,850 at current rates] for submitting the application referred to in paragraph 1 points 5 and 6, of which PLN 15,000 [approximately USD3,500 at current rates] shall be paid to the Agency’s bank account and the remaining amount to the Authority’s bank account…”.

(Art 15 (1) of the Act of March 2023, provides that “[t]he Supreme Bioethics Commission shall operate at the Medical Research Agency, hereinafter referred to as the “Agency”, whilst the “Authority” is understood to be URPL/the Office (see Chapter 5 of the Act) and not the Supreme Bioethics Commission).

Clinical Trials Compensation Fund

Sponsors applying for clinical trial authorization are required to make a contribution to the Clinical Trial compensation fund. The fee is paid for each application for a clinical trial authorization submitted as of 14 April 2023. Proof of payment of the fee to the Fund must be attached to the application for authorization (this applies to any application, even if it concerns a low interventional clinical trial).

The amount of contribution to the Fund depends on the planned number of participants in the clinical trial.

In 2024, the amount of contribution to the Compensation Fund is:

1. up to 20 people – PLN 8,686.80;
2. from 21 to 50 people – PLN 17,373.60;
3. from 51 to 100 people – PLN 34,747.20;
4. more than 100 people – PLN 43,434.00.

In the event of an increase in the planned number of participants in a clinical trial, the sponsor should verify whether the next threshold indicated in the Act is exceeded as a result, and if so, supplement the contribution to the Fund to the level provided for the updated number of participants. A supplementary contribution to the Fund should be made before the clinical trial is changed (e.g. after obtaining permission for a significant change to the clinical trial consisting of increasing the planned number of trial participants, and before the start of the recruitment of additional participants).

Please refer to the URPL page to confirm the latest information.

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Payment is made through an electronic bank transfer.

Details of the bank account and additional details can be found on the URPL website. Please use the website as a direct source of information.

Compensation Fund

The payment details are below. It is important that the transfer contains identification details, to attribute the payment to the trial and its sponsor (such as EUCT number and sponsor name).

Details of transfer from abroad

Account holder: Clinical Trials Compensation Fund

Account number: PL18 1130 1017 0020 1591 5120 0002

Bank: Bank Gospodarstwa Krajowego, Al. Jerozolimskie 7, 00-955 Warsaw

BIC (SWIFT): GOSKPLPW

The amount of the payment to the Clinical Trials Compensation Fund depends on the planned number of participants in the clinical trial receiving the investigational medicinal product or in the control group.

The payment should be made in zlotys (PLN) taking into account the average exchange rate of the euro announced by the National Bank of Poland for the first time in the year in which the application for a clinical trial permit is submitted.

4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.

The Clinical Trial application is made by the centralized EMA CTIS portal. 

Sponsors wishing to use CTIS must have an EMA account. Users who do not have an EMA account can register through the EMA Account Management facility.

Organizations may need to go through additional registration steps based on the user management approach that was used for CTIS. The organization-centered approach enables user management by an administrator at the organization level, rather than at the level of an individual trial. This is intended for organizations that run various trials through CTIS. To make use of this organization-based approach, organizations must ensure that they are registered in the EMA Organization Management System (OMS) and must register a CTIS High-Level Administrator through the EMA Account Management webpage. 

Below are some guidance and training modules made available by EMA:

1. Getting started with CTIS – Sponsor Quickguide
2. CTIS Sponsor handbook
3. Reference Materials for Clinical Trial Sponsors

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

Not under Part I of the application.

Participant-facing material is only submitted within Part II of the application unless participant-facing material is linked to the endpoints of the clinical trial, and those shall be provided together with the protocol in Part I of the clinical trial application. However, there is no indication as to how those documents should be provided.

Please refer to section 3.11 for more information.