Guidelines on application for authorisation of clinical trials falling under the risk-adapted assessment of already marketed medicinal products under the licensed indication

13 April 2012, Updated 12 May 2014

Type A trials

The Danish Medicines Agency has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation, and we now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.

These trials are termed Type A trials.

Criteria to be met for a trial to be a Type A trial

A Type A trial must satisfy the following criteria:

  • The investigational medicinal products to be tested are authorised in an EU or EEA country
  • The investigational medicinal products are tested in the patient population they are licensed for
  • The investigational medicinal products are tested under the licensed indication, dose and route of administration
  • The investigational medicinal product is used alone or in well-described (dose, route of administration, duration) and known combinations with other medicinal products
  • The risk involved for the trial participants is on the same level as the risk of standard treatment

If the trial is to test an investigational medicinal product which is not marketed in Denmark, but in another EU member state, it is important to document that the trial site has experience in using the medicinal product. Such experience could be if the site has used the investigational medicinal product via compassionate use permit.

Placebo-controlled trials cannot be assessed under the risk-adapted approach because excluding a trial participant from licensed treatment could expose the trial participant to increased risk.

14-day assessment time

The Danish Medicines Agency offers an assessment time of 14 working days for Type A trials provided that the application is complete when we receive it.

There may be special circumstances related to the trial design or organisation which could imply that we are unable to offer risk-adapted assessment.

If we cannot offer risk-adapted assessment, we will give the applicant an explicit explanation why we cannot offer a faster assessment, and the trial will be assessed under the normal assessment times, i.e. the first reply is given within 30 working days from receipt of a complete application.

Assessment of the application

The assessment of the Danish Medicines Agency can be illustrated as follows:

 Assessment flow in the Danish Health and Medicines Authority for Type A trials

Form to be used as cover letter for the application

If you wish to submit an application for a Type A trial, it is important that it appears clearly from the cover letter that you wish to have the application assessed under on the risk-adapted approach.

We have designed a form for Type A trials, which can be used as a cover letter for the application.

The form may also be helpful in determining quickly if a trial falls under the risk-adapted assessment.

For example, the form lists the criteria to be met in order for the trial to fall under the scheme, and you must briefly describe how the trial treatment distinguishes itself from usual clinical practice.

Checklist for Type A trials

We have also prepared a checklist specifically for Type A trials. Among other things, it highlights those areas where we have most often found the protocol to be incomplete.

It is important that the protocol clearly identifies procedures that are critical in relation to the standard treatment of trial participants, as well as the data which are critical in relation to the credibility of the trial results.

Use DKMAnet, Eudralink or CD-ROM

The application is to be submitted electronically via DKMAnet, Eudralink or on CD-ROM.

Questions

If you have questions about risk-adapted assessment, please call +45 4488 9123 or send an email to kf@dkma.dk.

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