The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required.
Target Product Profile (TPP)
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
Target product profile (TPP) in the US
A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Submission of a TPP is voluntary. Purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through post marketing programs to pursue new indications or other substantial changes in labeling.
Target product profile (TPP) in the EU
The Target product profile is referred to as the Quality Target Product Profile (QTPP) in the EU. The quality target product profile forms the basis of design for the development of the product. Considerations for the quality target product profile could include:
- Intended use in clinical setting, route of administration, dosage form, delivery systems;
- Dosage strength(s);
- Container closure system
- Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (e.g., dissolution,aerodynamic performance) appropriate to the drug product dosage form being developed;
Drug product quality criteria (e.g., sterility, purity, stability and drug release) appropriate for the intended marketed product.
Latest Glossary Definitions
The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make medicines that are still under development available to patients.
An accredited body that conducts conformity assessments for medical devices.
Affordability is the capability to allocate financial funds to an individual or societal need.
Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).
An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not collected in the context of highly-controlled RCT's.
A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.
An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined period.
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
HTA is a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of health technology in a systematic, transparent, unbiased, robust manner.