Talk:Regulated Product Submission Release 2 (RPS R2) Conceptual Model

RPS R2 Conceptual Model

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Entity Relationship Diagram

JASON ROCK: Package cannot have a recursive relationship to itself. The package is what the sponsor sends to the FDA. The regultory activity is what links two packages together - there is no relationships from one package to another.

EU perspective - clarification of understanding of the terms "regulatory activity", "package" and "dossier"

KLAUS MENGES:

From the EU perspective I have some questions in regard of correct understanding some items:

Regulatory activity can be understood as the type of submission as detailed in the envelope of the EU Module 1 of the eCTD sprcification:

• initial-maa = Initial Marketing Authorisation Application
• supplemental-info = Supplemental Information (could include, for example, response to validation issues or response to questions)
• fum = Follow-Up Measure (includes post-approval commitments for national MAs)
• specific-obligation = Specific Obligation
• var-type1a = Variation Type IA
• var-type1b = Variation Type IB
• var-type2 = Variation Type II
• extension = Extension
• psur = Periodic Safety Update Report (PSUR)
• renewal = Renewal (yearly or 5-yearly)
• asmf = Active Substance Master File
• referral = Referral under Article 29, 30, 31, 35 or 36
• annual-reassessment = Annual Reassessment
• usr = Urgent Safety Restriction
• article-58 = Article 58 (to be used for an initial application)
• notification-61-3 = Notification 61(3)
• transfer-ma = Transfer of a marketing authorisation
• corrigendum = Correction to the published annexes (usually shortly after approval)
• lifting-suspension = Lifting of a suspension
• withdrawal = Withdrawal during assessment or withdrawal of a marketing authorisation
• paed-article-29 = Paediatric submission, Article 29
• var-nat = National variation (e.g. national variation to apply for a pack size that is already registered within an existing MRP/DCP authorisation)
• reformat = Intended to support the reformatting of an existing submission dossier from any format to eCTD, i.e. a baseline eCTD submission containing no content change and which will not be subject to review]

This will of course reflect European needs but can be extended or remain as one of several reginal or in another way customised list.

Package - is that term to be understood as sequence in the meaning of "A single set of information and/or documents supplied at one time by the applicant as a part of, or the complete, dossier. In the context of eCTD, this is equivalent to a ‘sequence’"?

The terms dossier and application seem to be different. Is there a need to integrate "application" as well. From european perspective you can a definition like this: "Set of documents specified by Eudralex Volume 2B in accordance with CTD requirements to describe and justify an application within a specific type of procedure and regulatory activity. A dossier might be related to several applications depending on the granularity of strength, pharmaceutical form and product names. The most common use is of one dossier per product name." But htis need to be aligned for a more common use.