Receipt of clinical trial applications (CTA) summer 2011

Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 20 June 2011 to 2 August 2011 (weeks 25-30). CTAs can be sent to IMA during that time period. However, the application will not be validated (day 0) until after 2 August 2011.

IMA encourages applicants to take those dates into account when planning a CTA submission.

Applying for a clinical trial

One paper copy of the CTA and all data should be submitted. A CD ROM with all the documents should also be provided.

Please use the applicable checklist for the preparation of the CTA. Attach the completed list to the application.

Checklist IMP with marketing authorisation in EEA (May 2011)

Checklist IMP without marketing authorisation in EEA (May 2011)

Before the CTA can be validated by IMCA the documents according to the checklist have to be enclosed. In addition the application fee has to be payed, an invoice will be sent.

If the application fee has not been paid by deadline the application will be considered invalid.

Advice

• The Icelandic Medicines Agency offers Scientific Advice (see information regarding the tariff, /Icelandic_Medicines_Control_Agency/Legislation/Fees/).
• The Clinical Trial Facilitation Group (CTFG) a group within the European Medicines Agency (EMA) assists clinical trial applicants and invites them to contact the Innovation Task Force (ITF). IFT is a multidisciplinary group and the CTFG can organise ITF briefing meetings (free of charge) to provide guidance on regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products. The Icelandic Medicines Agency can assist with contacting the ITF.

For more information please see the EMA webpage.

Should you have any questions please do not hesitate to contact the ITF secretariat: ITFsecretariat@ema.europa.eu

Covering letter

A covering letter must accompany the CTA, which includes the title of the trial, EudraCT number, and the protocol number of the sponsor. Specific issues and concerns related to the trial should be highlighted, e.g. if a scientific advice is associated with the trial.

The letter must also state the importer of the investigational medicinal product and which pharmacy will store it. If the applicant has requested to be exempted from storing the investigational medicinal product in the custody and supervision of a pharmacy or hospital pharmacy, standard operating procedures regarding reception, handling, delivery, storage and disposal should be included in the application.

How the sponsor will inform about suspected unexpected serious adverse reactions (SUSARs).

A print-out of the application from the EudraCT system

The CTA shall be submitted in a printed form and the EudraCT application in an .xml format on a CD.

A copy of the allocation of the EudraCT number

EudraCT is a database for all clinical trials within the European Economic Area (EEA), in which applications to all the European medicines agencies are filed. The database is made in accordance with Directive 2001/20/EC. Applicants/sponsors can access the database through the internet in order to:

· Apply for a EudraCT number – http://eudract.emea.europa.eu

• Fill in, save and print an electronic version of the filled-in application form for clinical trials

Access to the database proper is restricted and only the European medicines agencies within EEA, EMEA and the Council of Europe can access it.

Detailed guidance on filling in the EudraCT for applying for a clinical trial in Iceland can be found on the EMEA website, www.emea.europa.eu

Guidance on applying for a EudraCT number

EudraCT number – the ID of the clinical trial

In order to have a specific reference to the clinical trial with at least one centre within the EEA, each trial receives a specific number – EudraCT number. That number must feature in all applications for clinical trials within the EEA as well in other documents related to the trial (e.g. SUSARs). Getting a EudraCT number is a two-step process comprising the items described below.

The structure of the EudraCT number is YYYY-NNNNNN-CC, where

YYYY is the year when the number was published

NNNNNN is a six digit sequential number

CC is a validation number

Step 1 – Applying for a safety code

The first step involves receiving a confirmed safety code. This code is sent to the email address, which the applicant denotes in the application and is essential in order to finalise the application fro a EudraCT number. The safety code is only valid for one EudraCT number and expires 24 hours after application.

Step 2 – Applying for a EudraCT number

This step is the application proper for a EudraCT number. In this step the safety code from Step 1 must be utilised. The EudraCT number is sent to the email address, which the applicant denotes in his application.

Signature form

A signature form must be attached to the CTA, signed by the principal investigator (PI). If the trial is conducted in a hospital or other health organisation, then a senior physician, head of department or organisation must also sign the form. It the trial is conducted in cooperation with a sponsor, his representative must also sign the form. In the absence of a sponsor the PI takes on the role of the sponsor.

Multi-centre trials are regarded as one trial. In such cases only one application shall be submitted to IMCA along with the signature form signed by the coordinating investigator/ supervisor of the trial. Signature forms signed by the PIs at each investigator site (centre) in Iceland must also accompany the letter.

The Signature Form

Protocol

A protocol must be submitted, stating inter alia the objective, set-up, methodology, statistical methods and the design of the trial.

It should be stated whether the trial is a part of a multinational clinical trial.

The trial must be conducted in accordance with Regulation No 443/2004 and rules on good clinical practice (GCP).

Investigator’s Brochure

The application must be accompanied by a summary of clinical and pre-clinical data on the investigational medicinal product(s) which is relevant fro a clinical trial on the medicine(s) in humans. The brochure must include a risk-benefit assessment.

Investigational Medicinal Product Dossier (IMPD)

Summary of the chemistry, pharmaceutics, pharmacology in animals, toxicology, pharmacology in humans and clinical properties of the medicinal products must be submitted.

Further information regarding the quality of the IMP, comparator and placebo can be found in EMA‘s guidelines about the IMPD (CHMP/QWP/185401/2004).

Manufacturing licence, GMP certificate or a corresponding inspection report/letter from respective regulatory authorities

A certificate from all manufacturing units, including packaging, labelling and batch release must be submitted

If the investigational medicinal product is not manufactured within the EEA and does not have a marketing authorisation in EEA, a statement is needed from the Qualified Person (QP) of the importer into the EEA, stating that the medicine is manufactured in accordance with GMP rules and that research has confirmed the quality of the product. The QP can come from whichever country within the EEA.