Investigational Medicinal Product Dossier (IMPD)

A dossier can be understood as a process of accumulating files of documents or papers and or other sources on any specific subject or maybe about a particular person, event, or subject that contains elaborative information about that topic. E.g.- Patient medical record
IMPD can be defined as the foundation for approval of clinical trials or to start any clinical trials in the European Union by skillful authorities. The IMPD (Investigational Medicinal Product Dossier) can be considered as one of the few bits of Investigational Medicinal Product (IMP) related details or particulars required at the time of performance of a clinical trial or subject in one or more European Union Member States.

The requirement of full IMPD comes into play when little or no information about an IMP (Investigational medicinal product) has been previously submitted to competent authorities when applying for clinical trial authorization. Simplified IMPD may be sufficient in situations where the data or information has been evaluated previously as part of the authorization of the market.

The IMPD is composed of a compilation of data, information related to the quality, manufacture, and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies.

Requirements of IMPD:

1. Although the IMPD is composed of a compilation of all the data and the documents provided to each member state (MS) which is required to obtain permission to start clinical trials, there are also requirements of other supporting documents that need to support the IMPD before the grant of approval by the component authorities of each MS, as they may vary from country to country.
2. Much of the information in the IMPD is contained in the IB which is a very elaborative document.
3. In this case, therefore applicant can either provide an independent IMPD or cross-refer to the IB for the details required for preclinical and clinical parts of the IMPD as the Investigators Brochure (IB) which has adequate data, information to allow assessors to finalize a decision about the clinical trial, the possible toxicity of the IMP and safety or efficacy of its use in the proposed trial.

The following should accompany the IMPD:

1. Receipt of confirmation of EudraCT number
2. Covering letter
3. Application form
4. List of all CAs where the application has been submitted
5. Copy of IEC approval or comments
6. Any letter of concern received from any MS
7. Copy of any scientific advice
8. A letter of authorization for use when the applicant is not the sponsor
9. Confirmation that CA will accept applications in English
10. Informed consent form
11. Subject information (if any)
12. Arrangement for recruitment of subjects
13. Protocol with any amendments
14. Summary of the protocol in the national language
15. Peer review of trial if available
16. Ethical assessment by principal investigator ′ Investigators Brochure′
17. Report of any trial with same IMP
18. Example of the label in the national language

Overall Content of IMPD?

• Summaries of information or data related to the quality, manufacture, and control of the IMP should be included in an IMPD.
• Nonclinical trials data and data from its clinical use, if any, should be included.
• The format recommended of the IND presentation of the data in tabular form with a brief explanation of the main points is acceptable.
• Although the format, as stated in the above reference, is recommended although it is not mandatory.
• It is advised that sponsors can use this detailed guidance as a starting point in their IMPD submissions.

Listing of the data that should be included in the IMPD is as follows:
1. Quality Data

• This comprises data accumulation of chemical, pharmaceutical, and biological domains on the IMP.
• The data to be used for a clinical trial should be based on IMPs whose manufacture should comply with the principle of good manufacturing practice.
• If the IMP is manufactured in the European Union (EU) and does not have marketing authorization in the EU should be stated in a copy of the manufacturing authorization.
• In case if the IMP is not manufactured in the EU and does not have a marketing authorization in the EU.
• The qualified person who works in the manufacturing site should comply with GMP, particularly EU GMP.
• GMP status of any active biological substance should be certified.
• Copy of the importers’ authorization is needed.

2. Non-Clinical Pharmacology
This justifies the use of various data for any IMP whether to be used in the clinical trial or not, which includes information from Nonclinical pharmacology and toxicology.

3. Previous Clinical Data
This data section provides information or data of all previous clinical trials and human experience with the proposed IMPs.

4. Overall Risk and Assessment
As the name suggests, this section includes a critical assessment of the risks and benefits of the proposed trial. Inclusion of critical assessment of the nonclinical and clinical data is needed.

The Assessment of the IMPD in Another Clinical Trial Application
The current version of the SmPC (Summary of Product Characteristics) can be submitted by the applicant (or, as regards ICH countries, the documentation equivalent to the SmPC) as the IMPD if an IMP has marketing authorization in any Member State or an ICH country.

Moreover, it may so happen that similar IPMD might have been submitted by the same or another applicant in the past and held by the national competent authority of the respective Member State. In such cases, the new applicants can cite the earlier similar submissions. In the event where the submission was performed by another applicant, the new applicant is required to obtain an authorization letter that would give rights to cross-refer the data from the previous submissions.

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