CRED SMPC 2024

17/09/2024

Regulatory plan

When

Early formation of the draft label allows for:

● Identification of areas where further studies are needed – Amendments to the development programme or label/CCDS ● Clarification of potential areas of risk

● Potential marketing positioning vs competitors

● Appropriate strategies and influencing plans

A Regulatory plan should include:

● A description of the risks

● The probability of not achieving the minimum required labelling

● Actions to be taken to resolve issues

● The current status of the product (i.e. how close you are to the optimum label)

The Organisation for Professionals in Regulatory Affairs

15

Other considerations for “when”

When

Proactive management of Health Authority interactions:

• Such as Scientific Advice meetings, end of phase II, pre-submission meetings)

• Draft SmPC can be a powerful tool for discussion

• Provides framework for negotiations

When will the user-testing/consultation with target patient groups take place? Pre-submission or during the procedure ? • User-testing prior to submission could require earlier drafting/internal alignment for some sections of the SmPC

Pharmaceutical information needed for the label text

• Needed to create mock-ups for submission

The Organisation for Professionals in Regulatory Affairs

16