Outline of clinical trial submission procedure
From 1 January 2018 timeline for authorisation of clinical trials is 75 calendar days that includes a 60-day timeline to provide the ethical opinion. In the case of an investigational medicinal product (IMP) that is connected with gene therapy or somatic-cell therapy or a genetically modified organisation, timeline for authorisation is 90 calendar days that includes a 72-day timeline for ethical opinion. When the IMP is connected with cell tharapy of xenogen cells, timeline for authorisation is 12 months that includes a 11-month timeline for ethical opinion.
Background of the extended timeline of authorisation
The General Regulation of Public Administration (Act CL., 2016) came into effect on 1 January 2018. The new act declares that (contrary to the previous regulation) during the time questions are being responded the clock should not stop. Differently from the former regulation the response time is limited to 15 days in each case. This 15 days is added as a plus period to the whole process resulting a total of 75 days timeline. If more time is needed for the response, Applicant has the right to ask the NCA to suspend the approval process. The maximum period of suspension is 6 months. As long as the Applicant’s request for suspension arrives at NCA, the clock stops. Applicant should ask to re-start the process in parallel with the submitted reply.
Outline of clinical trial submission procedure
- The approval process starts when the submission arrives at OGYÉI. Next day means the first day of the process.
- Within 8 days from NCA declares in a written form that the decision regarding the application will be finalized in 75 days and informs the Applicant if application dossier is not complete and supplementation is needed. NCA gives a 7-day deadline for the supplementation (clock does not stop). If the missing documents are not submitted in 5 days, NCA makes its decision in the presence of the available documents or terminates the approval process.
- NCA forwards the whole submission to the Ethics Committee and requires their official opinion.
- Both NCA and Ethics Committee may request further clarifications and/or some modifications if questions or comments raised during the assessment of the application dossier. NCA gives a 15-day deadline for the response (without clock stop). Ethics Committee determines the deadline in the letter where their questions are defined. If the requested additional information does not arrive within the defined timelines, NCA makes its decision in the lack of the given document(s) or terminates the approving process.
- Suspension of the approval process can be asked if the Applicant needs more time for the response. The maximum period of suspension is 6 months. When the response is compiled the dossier should be submitted accompanying with a request to re-start the process.
- In the case of a properly composed dossier where questions are fully replied, and Ethics Committee gives a positive opinion, NCA approves the clinical trial. If questions are not fully responded or there are missing documents or Ethics Committee gives a negative opinion, NCA refuses the authorisation.
Timeines now and according to the forthcoming Regulation EU No 536/2014
Documentation to be submitted
Documentation should be submitted in two identical copies (in case of immunological submissions 3 copies are needed on CD).
Check list and recommended structure of the submission
- Covering letter
- Receipt of confirmation of EudraCT Number
- Application form xpl and pdf format Statement of identity
- Letter of Authorisation
- Proof of payment
Protocol related information
- Protocol with all current amendments
- Summary of the protocol in Hungarian language
- Protocol signature pages
- Scientific advice
Subject related information
- Informed consent form
- Subject information leaflet
- Arrangements of recruitment of subjects
- Other documets (patient card, diary ect)
IMP related indformation
- Investigator’s Brochure
- Investigational Medicinal Product Dossier (IMPD)
- Simplified IMPD for known products
- Summary of Products Characteristics (SmPC) (for products with marketing authorisation in the Community)
- Copy of the manufacturer authorization if the IMP is manufactured in the EU
- Declaration of the qualified person that the manufacturing site works in compliance with EU GMP (when applicable)
- Analytical Certificate of IMP
- Examples of the label in Hungarian language
- Copy of the importer authorisation
- Viral safety studies
- TSE Certificate when applicable
- Declaration of GMP status of active biological substances
- Insurance certificate
- Costs of clinical trials, division of costs between the hospital and investigator
- Compensation to subjects
Facilities and staff related information
- Curriculum Vitae of the Hungarian principal investigators
- Site related documentation
Additional information for special situations
- radiopharmaceuticals products
Site related information of the Application Form must be filled in Hungarian. Title of the trial may also be written in national language in A.3 point of the Application Form version 8. This may help patients, who do not speak English to search in Clinical Trials Register.
Fees charged for authorization procedures related to Clinical trials, and amendments
Schedule No. 1 to Act XCV of 2005
New Clinical Trial submission:
- 580.000 HUF have to be paid
- 110.000 HUF have to be paid
- CEC- Central Ethics Committee (ETT-KFEB - Medical Research Council Ethics Committee for Clinical Pharmacology, - Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága)
- OGYÉI- National Institute of Pharmacy and Nutrition
- HP- Voluntary Harmonisation Procedure