Investigational Medicinal product Dossier (IMPD)

IMPD-Gateway to Clinical Trials in the EU

The Investigational Medicinal Product Dossier (IMPD) is a regulatory document that contains all relevant information about the quality, manufacture, and control of an investigational medicinal product (IMP). It supports a Clinical Trial Application (CTA) submitted under Regulation (EU) No. 536/2014. The IMPD ensures that the investigational product is safe, of sufficient quality, and suitable for administration to human subjects during a clinical trial.

According to EMA’s Guideline on Chemical and Pharmaceutical Quality Documentation (Rev. 2, 2022), an IMP can be:

  • A novel active substance
  • A modified version of an authorized product
  • A comparator product
  • A placebo

The IMPD can be a full dossier or a simplified version, depending on the nature of the product and its development stage. For example, early-phase clinical trials may require less data than late-phase or modified products.

Importance of IMPD

  1. Regulatory Approval: Without an IMPD, your clinical trial cannot be approved in any EU Member State. The dossier demonstrates that the product is adequately characterized and manufactured in accordance with Good Manufacturing Practice (GMP) standards.
  2. Patient Safety: The IMPD addresses risks related to toxicity, impurity levels, and stability. These are vital to protecting the health of trial participants.
  3. Product Consistency: The dossier ensures that your investigational product is consistent across all batches and trial sites, which is crucial for generating valid clinical data.
  4. Transparency and Harmonization: Since many clinical trials are multi-centre or multinational, a standardized dossier helps regulatory authorities across the EU assess your submission consistently.

How to File an IMPD in the EU

Filing an IMPD follows a structured process:
Step 1: Compile the IMPD as per EMA Guidelines
Use the Common Technical Document (CTD) format—especially Module 3 (Quality). IMPD quality sections should reflect development stage—early-phase dossiers may have broader specifications.
Step 2: Ensure GMP Compliance
Confirm all manufacturers hold valid EU GMP certificates, including any subcontractors responsible for packaging, testing, or releasing the product.
Step 3: Use the Clinical Trials Information System (CTIS)
Under EU Regulation 536/2014, sponsors must now submit CTAs and IMPDs through CTIS, a centralized digital portal for all EU/EEA Member States.
Step 4: Submit Nationally or via CTIS Work-sharing
Depending on your trial’s scope (single-country or multi-national), you may submit to one or several authorities. Work-sharing via CTIS facilitates harmonized review.
Step 5: Prepare for Questions or Requests for Modification
Regulatory authorities may ask for clarifications, additional data, or protocol amendments. Prompt, clear responses will reduce approval timelines.

Challenges in IMPD Filing

Filing an IMPD can be complex due to:
  • Variability in drug substance quality
  • Evolving clinical trial designs
  • Multisite manufacturing
  • Ongoing modifications during trial progression

Each of these can lead to deficiencies or delays if not addressed early and comprehensively.

At Masuu Global Quality and Regulatory Consultants,

we specialize in:
  • Preparing complete or simplified IMPDs in CTD format
  • Ensuring GMP alignment for all manufacturers
  • Handling bioequivalence and comparator product data
  • Addressing regulatory agency queries
  • Providing gap analysis and dossier review

Whether you’re at phase I or planning for phase III trials, our team provides customized support tailored to your molecule, trial scope, and regulatory pathway. We ensure compliance with the latest EMA guidelines, including Rev. 2 of the Chemical and Pharmaceutical Quality Guidance (2022).

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