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...