Target Product Profile (TPP) is a key document which provides information to the Food and Drug Administration (FDA) about the drug development process. The purpose of a TPP is to ensure that the drug development process of the manufacturer is efficient and provides all the required relevant medical, technical and scientific information for evaluating the commercial outcome of a drug. It provides the overall intent of the drug and gives the status of the drug at any given point of time in the development process. Historically, the TPP was used as a format of discussion between the manufacturer and the FDA.

The TPP consists of sections specific to drug labeling linking specific concepts to the drug development activities. TPP is a dynamic document and should be updated regularly to keep up with the new information and changes related to the clinical development of the drug.

Sections of a TPP

Generally, a TPP consists of the following sections:

  • Usage information and indications
  • Administration of dosage
  • Dosage forms and the strength of the drug
  • Contraindications, if any
  • Precautionary warnings
  • Adverse reactions and drug interactions/abuse
  • Information about overdose
  • Description of various aspects of the drug
  • Clinical pharmacology and nonclinical toxicology
  • Clinical studies
  • References
  • Information regarding storage and handling and how it should be supplied
  • Information about patient counseling

How to draft a TPP?

1. To draft a TPP, all the sections should be completed duly by incorporating necessary information related to the stages of drug development. Any issues or questions that need to be resolved should also be included in the TPP. The following pointers must be included in each section:

  • Target – Includes the labeling language that is intended to be achieved based on the studies mentioned
  • Annotations – Includes information related to the completed or planned studies
  • Comments – Includes further information which can be useful for the communication

2. Manufacturers are required to update the milestone box, which can be located at the top of the TPP.
3. The TPP should be updated at appropriate milestones with highlighted information. Once the TPP is implemented, it can be further used for the final labeling discussion.

Benefits of a TPP

  • Serves as a strategic tool for the manufacturers
  • Communication tool between the manufacturer and the health authorities as well as the stakeholders
  • Helps in assessing the progress of the drug development process
  • Helps in preventing failures at a later stage of development
  • Provides a clear picture of the outcome of the process

A TPP can be extremely useful during the meetings of early drug development stages. Therefore, maintaining it is a necessity. Are you looking for assistance with respect to TPP? Reach out to us at