EMA CTD Module 1 — Regional Administrative & Prescribing Information

EMA CTD Module 1 MAA SmPC PIL Regulatory

Overview

Draft and validate EU Module 1 of the Common Technical Document for MAA: application form, SmPC, PIL, labelling, and environmental risk assessment per EU requirements.

Example Conversation

You: We’re preparing Module 1 for our centralised MAA. Can you draft the SmPC and PIL per QRD template and then validate the Module 1 package?

Agent: I’ll draft the SmPC with QRD headings (composition, pharmaceutical form, therapeutic indications, posology, contraindications, undesirable effects, storage), then the PIL aligned with the SmPC, and add application form and labelling placeholders. Then I’ll run ctd_module1_section_validator on the Module 1 document.

Agent: Created module1-draft.md. Running ctd_module1_section_validator…

Agent: Check PASS — Module 1 sections 1.0–1.5 are present, SmPC has the required QRD-style headings, and PIL cross-references SmPC. For a new active substance, ensure ERA Phase I PEC is included; I’ve added a placeholder. Ready for your review.

What the Tools Validate

The skill includes one extension tool:

ctd_module1_section_validator checks Module 1 for:

Mandatory sub-sections (1.0–1.5) — Application form, SmPC, PIL, labelling, environmental risk assessment, and related administrative content must be present or referenced.
SmPC QRD headings — SmPC must include key QRD-style sections (e.g. composition, pharmaceutical form, indications, posology, contraindications, undesirable effects, storage).
PIL–SmPC alignment — PIL must cross-reference or align with the SmPC.
ERA Phase I — For new active substances, ERA Phase I / PEC calculation should be present (or N/A documented).
Orphan/paediatric — If applicable, orphan drug or paediatric provisions should be flagged.

Output: PASS if mandatory sections and SmPC/PIL checks are satisfied; otherwise FAIL with a short line per missing element. Run on the Module 1 draft before submission; fix gaps and re-run until the check passes.

Output Excerpt

Excerpt from a generated Module 1 draft and sample validator report.

Module 1 (excerpt):

## 1.0 Application form
[Centralised procedure MAA – placeholder for completed application form]

## 1.1 SmPC (Summary of Product Characteristics)
1. Name of the medicinal product / qualitative and quantitative composition
2. Pharmaceutical form
3. Therapeutic indications
4. Posology and method of administration
...

## 1.2 Package leaflet (PIL)
Patient information aligned with SmPC sections 1–10. [PIL content]

## 1.4 Environmental risk assessment
ERA Phase I: PEC calculation [or N/A if not new active substance].

ctd_module1_section_validator report (excerpt):

=== CTD MODULE 1 SECTION VALIDATOR (EMA) ===
Result: PASS

Document: module1-draft.md
Module 1 section 1.0 is present.
...
SmPC has key QRD-style headings (7 of 7 checked).
PIL cross-references or aligns with SmPC.
Module 1 meets CTD Module 1 section expectations.

Getting Started

Add your source materials to the project workspace (application form data, product information, QRD templates), then activate the EMA CTD Module 1 — Regional Administrative & Prescribing Information skill. The agent will guide you through the application form, SmPC, PIL, labelling, ERA, and running ctd_module1_section_validator before submission.