CRED Understanding Clinical Development 2024

08/10/2024

Capturing PIP strategy – a useful tool

Aspect of PIP

Birth to <2 years

2 to <18 years

PIP condition

Treatment of cough

PIP indications

Treatment of dry cough; treatment of post-viral cough

Does not occur

Waiver

No significant benefit

No waiver available

Age-appropriate formulation Juvenile animal studies

Develop oral liquid

1 rat tox study relevant for children aged ≥2 years

One age-staggered clinical trial in children aged 2 to <17 years. Age cohorts 12 to <18, 6 to <12 and 2 to <6 years.

Clinical

Not required due to waiver request

Modelling & simulation

Yes. Objective is to identify likely optimum dose(s) in advance of paediatric clinical trial.

Extrapolation

No

Request deferral for completion of oral liquid development and juvenile animal study. Request for initiation and completion of modelling exercise and paediatric clinical trial.

Deferral

The Organisation for Professionals in Regulatory Affairs

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Class waivers

• There is a published list of class waivers (CW/0001/2015) which is periodically reviewed and revised

• The objective is to facilitate automatic exemption from the paediatric legislation for products which have no paediatric utility

• Some class waivers are tied to the disease:

• All classes of medicinal products for treatment of Alzheimer’s disease

Others are tied to the drug class

•

• PPAR- γ modulators for treatment of type II diabetes mellitus

The guidance on class waivers can be quite unclear so be careful !

The Organisation for Professionals in Regulatory Affairs

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