About Investigational Medicinal Product Dossiers

What is an IMPD?
The Investigational Medicinal Product Dossier (IMPD) is one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States. The IMPD includes summaries of information related to the quality, manufacture and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies.

Guidance and legal basis
Guidance concerning IMP Dossiers can be found in the communication from the European Commission titled “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial”.

The guidance is based on Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use (Repealing Directive 2001/20/EC) on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (also commonly referred to as the ‘Clinical Trials Directive’).

The Regulation comes into force in 2016, harmonising the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice (GCP) in the conduct of clinical trials on medicinal products for human use.  European Member States have transformed the requirements outlined in the Directive into the respective national laws.

Full and simplified IMPDs
The guidance allows for the IMPD’s content to be adapted to the existing level of knowledge and the product’s phase of development.

When applying for a clinical trial authorisation, a full IMPD is required when little or no information about an IMP has been previously submitted to competent authorities, when it is not possible to cross-refer to data submitted by another sponsor and/or when there is no MA in the Community.

However, there are situations where a simplified IMPD will be sufficient.  A simplified IMPD may be submitted if information has been assessed previously as part of a Marketing Authorisation in any MS or a clinical trial to that competent authority.

There are also situations where the SmPC of a Marketed Product will suffice as the IMPD. A SmPC may be submitted if the IMP has a Marketing Authorisation in any EU Member State and is being used in the same form, for the same indication and with a dosing regimen covered by the SmPC.  The SmPC will also be sufficient for studies of dosing regimens where the Sponsor can demonstrate that information in the SmPC justifies the safety of the new dosing regimen.

What is the format of an IMPD?
There exists guidance on the section headings to be used in a full IMPD, although the format is not obligatory.  The IMPD can also follow the structure of a Common Technical Document (Module 3).  The IMPD need not be a large document as the amount of information to be contained in the dossier is dependent on various factors such as product type, indication, development phase etc.  If limited or no data is provided within the technical headings, then this must be properly justified.  Certain products such as vaccines, antibodies and gene therapy, are also covered by other EU guidelines and have additional data requirements.

What is a Substantial Amendment?
The assessment of an IMPD is focussed on patient safety and any risks associated with the IMP.  Whenever any potential new risks are identified the IMPD has to be amended to reflect the changes.  Certain amendments are considered substantial in which case the competent authority has to be informed of the substantial amendment.  This may be the case for changes in IMP impurities, microbial contamination, viral safety, TSE and in some particular cases to stability when toxic degradation products may be generated.  Further information about substantial amendments can be found here.