Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
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
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference o
It refers to the parallel consultation between European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (
Individual Parallel Consultations are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination with centralised HTA recruitment, consolidated HTA comments and List of Issues, albeit with individual HTA written reports as the final product.
Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region.
The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated Parallel Consultation.
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.
A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.