Target Product Profiles in Drug R&D – Regulatory Profiles
Regulatory Target Product Profiles (RTPPs)
RTPPs describe the aims of a drug development programme in terms of labelling concepts. They can be used by regulatory agencies to quickly see the claims the developer is aiming for with a new drug and therefore the data, experimentation and clinical trials needed to support these claims from the regulatory perspective.
An RTPP is a valuable reference document that helps the drug developer and regulatory agency understand the entire drug development process, from pre-investigational new drug application (pre-IND) through post-approval programs to pursue new labeling claims or indications. An RTPP is not a necessarily a fixed description of the aims of drug development but may change as more becomes known about the nature of the drug under development.
- Possible sections of an RTPP could include:
- Therapeutic area
- Indications and usage
- Patient population
- Dosage, dosage form and administration
- Claims and labelling
- Clinical pharmacology
- Proposed clinical programme and data to be provided
- Toxicology programme and data to be provided
- Contraindications and drug interactions
- Adverse reactions
- Warnings and precautions
- Potential for abuse
- References
A well-organized RTPP enables the drug developer to make best use of resources through focused interactions with regulatory agencies. It can also help to:
- Ensure the alignment of data collection and trial end points with regulatory requirements
- Enable the timely collection of safety data
- Improve labelling content
- Potentially reduce the time to patient
However, care must be taken with Regulatory TPPs. They can certainly enable the regulatory process but may not lead to successful drugs from the developer’s perspective. Careful referencing of the Aspirational TPP should be made to ensure that the developer’s critical objectives for the drug are being met, or experiments are being designed and data collected to test whether the drug can meet these objectives.
Here we have described TPPs in terms of 3 different forms to aid understanding of their different uses and forms and who they be most useful for.
A general introduction to the three kinds of TPP, plus more detail on the other two, are available in related articles in this section.
Our associates have many years’ experience in the use of TPPs. Get in touch with us – we’d be pleased to talk to you about TPP development and use.
Written by Graham Finch, Nick Brindley, Mike Florence and Pauline Stewart-Long