Post-Approval Commitments

Our commitment to patient safety, scientific excellence and ethical transparency do not end with a new medicine’s approval.

Continued study and clinical testing are just part of our ongoing commitment to bringing safe and effective medicines to patients worldwide. The studies that Pfizer designs and carries out in Post-Approval Commitments (PACs) allow us to better understand a new medicine's safety, efficacy, or optimal use, and learn how that medicine might further impact the lives of patients around the world.

PACs are an important mechanism for furthering Pfizer’s dedication to developing safe and effective medicines for patients around the world, and meet our ongoing commitment to serving patients through the highest standards patient safety, scientific excellence and ethical transparency.

PACs can broadly include investigations such as:

  • Randomized clinical trials (RCTs)
  • Efficacy studies
  • Completion of ongoing study
  • Pediatric studies
  • Special population studies
  • Safety studies
  • Large simple trials (LSTs)
  • Safety registry
  • Epidemiological studies
  • Drug interaction studies
  • Pharmacokinetic and pharmacodynamic studies
  • New dosage form/strength studies
  • Pre-clinical studies

PACs for additional study and testing are made in agreement with a governmental health authority, such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) and can issued by any worldwide health authority as part of the product approval or after the medicine has been on the market.*

You can find more information about U.S. PACs as well as search a database for a list of PACs on the FDA website.

General European Medicines Agency (EMA) information about PACs can be found at the European Medicines Agency website.

*terminology may differ worldwide – “PAC” chosen to describe any investigations that meet this definition