Post Marketing Commitments
As part of the United States regulatory approval process for new medicines, new uses of existing medicines and the continuous monitoring of safety, companies may be required to conduct additional studies and testing to support the safety and effectiveness of their medicines. In the European Union (EU) companies can be required to conduct additional studies and testing to support the safety and effectiveness of their medicines, or to carry out other defined activities, at any time in the life of a product, These studies, testing and other activities are referred to as post marketing commitments (PMCs). This Web site provides some general information about how post marketing commitment studies are conducted, as well as status information for post marketing commitments listed for US products and for products approved via the Centralized Authorization Procedure (CAP) in the EU.
Food and Drug Administration (FDA) information about US post marketing commitments can be found at the FDA Web site.
European Medicines Agency information about post approval commitments can be found at the European Medicines Agency website.
About the Information Posted on This Web Site:
This Web site contains information about Pfizer’s post marketing commitments for pharmaceutical products in the US and for medicinal products approved via the CAP in the EU. The post marketing commitments listed here include pre-clinical, clinical and epidemiological studies or testing and for the EU other activities agreed to by Pfizer (including its group companies/subsidiaries) and the FDA or European Medicines Agency, and are used to gather additional information about the safety, efficacy, or use of approved Pfizer medicines, or help ensure their safe use. This Web site provides the current status of Pfizer post marketing commitments listed on the FDA Web site. It includes post marketing commitments established for Pfizer medicines in the US since August 1, 2000 and for EU medicinal products approved via the CAP. New post marketing commitments will be added to this Web site as they are established.
This Web site does not contain technical chemistry, manufacturing and control (CMC) commitments, or commitments for medicines for which a Pfizer group company is not the license holder. Information about Pfizer's post marketing commitments is believed to be correct at the time that the information is posted, and is subject to change as progress is made in fulfilling the commitments.
This Web site is updated monthly. The status of post marketing commitments shown on the FDA Web site may differ from information displayed on this site, due to differences in the timing of updates made to the FDA Web site. The number of commitments on the two sites may also differ, due to the frequency of such updates and/or due to multiple reporting of single commitments on the FDA Web site.