Recommendations on the Content of Dossiers Submitted for Bioequivalence (BE) Studies Allowing for Assessment within Accelerated Timeframe
The most common problem arising during validation are missing documents or incorrect payment. The sending of validation objections significantly prolongs the study assessment period. For this reason, please be advised of the below recommendations for submitters of BE studies to facilitate successful study validation, and hence assessment within accelerated timeframe.
CTIS:
Dossier PART I:
- Cover letter – stating that it concerns BE and that the sponsor applies for accelerated assessment
- Payment – due to the fact that it concerns chemically manufactured products and the Czech Republic will be the only country where the clinical trial will be conducted, and hence will act as the RMS:
Payment for PART I K-018 = 75,600 CZK – it is possible to make the payment in advance pursuant to Guideline UST-29 and submit the proof of payment at the time the application is submitted, avoiding a validation objection concerning payment
- Protocol synopsis in the Czech language (technical or technical + lay person)
- Protocol
- Investigator´s Brochure or draft SmPC for the tested product
- Pharmaceutical documentation:
- SmPC (Summary of the Product Characteristics) for all authorised products that will be used in the study
- Labelling – proposed labelling in the Czech language for all products to be used in the study
- Manufacturing authorisation/GMP certificate and QP declaration (if some of the manufacturing, testing or packaging sites are located outside the territory of the EU/EEA)
- A reference to EU CT number for IMPD-Q only studies in case the sponsor does not have access to complete pharmaceutical documentation (e.g., ASMF procedures). For more information on IMPD-Q only studies, please refer to document “Clinical Trials Regulation (EU) No 536/2014 Questions & Answers (section 2 – Applications limited to Part I)”
Dossier PART II – as per Guideline KLH-CTIS-01:
- Template no. 1 – Trial subject recruitment and informed consent procedure
- Template no. 2 – Investigator´s CV
- Template no. 3 – Declaration of conflicts of interests
- Template no. 4 – Trial site suitability + Decision of Regional Authority that the site is a healthcare facility, specifying the scope of its operation + Good Clinical Practice Certificate issued by SÚKL for the site.
- Template no. 5 – Sponsor´s statement on personal data processing in the concerned clinical trial – may be replaced with the sponsor´s declaration of GDPR compliance, included in PART I, section FORM
- Template no. 6 – Compensation for study participants
- Template no. 7 – Processing, storage, storage conditions for biological samples
- Insurance certificate, Insurance policy, incl. terms and conditions of insurance
- Information sheet for healthy volunteers/informed consent
- Where advertising or other recruitment materials are to be used, these have to be submitted in the Czech language; where video or audio advertising or advertising on social networks is to be used, the text of this advertising/recruitment material has to be submitted.
- Proof of payment for PART II fee:
BE studies shall be always assessed by SÚKL´s Ethics Committee; the amount of the payment is based on the number of trial sites: 1 site K-023 = 44,100 CZK; 2 sites K-024 = 51,300 CZK. Payments are governed by the same Guideline as for PART I, but these cannot be joined in a single payment, but must be paid separately.
19th FEBRUARY 2024
Clinical Trials of Medicinal Products Department