Why did Pfizer develop this post marketing commitments website?
Pfizer developed this website to:
Provide timely and accurate information about Pfizer's listed post marketing commitments for medicinal products in the US and in the EU where approved via the Centralized Authorization Procedure to the public;
Provide education about the importance of post marketing research and other commitments and processes surrounding these efforts;
Demonstrate our commitment to continue learning about the optimal use of our medicines after approval;
Demonstrate our commitment to operate ethically, with integrity and transparency.
What kind of information is available on this website?
The website provides information on Pfizer's listed post marketing commitments for medicinal products in the US and in the EU where approved via the Centralized Authorization Procedure including:
Information on specific commitments, including information by Brand (for both US and EU brand names) and generic name, specific Pfizer company name (e.g., Pfizer company listed as the applicant), application number, approval date, due date, status, commitment type, commitment number, and commitment description;
Total listed and active Pfizer post marketing commitments, for medicinal products in the US and in the EU where approved via the Centralized Authorization Procedure, and totals by type and status;
- General educational information about the post marketing commitment study process, including post marketing commitment definition, study types, status definitions, and the study development process. Frequently asked questions and a glossary of terms are also provided. See About the Information Posted on This website.
Why do some post marketing commitment studies take so long to complete?
There are many steps involved in conducting studies. A protocol must be developed, and investigators (researchers) must be trained to conduct the study. Patient enrollment may take time for some studies, such as pediatric or sub-population studies. Some studies are designed to monitor the medicine over long periods of time to better understand the long-term effects. Furthermore, some safety studies may be required for the lifetime of the medicine. For more details, see Post Marketing Commitments Study Development Process.
How is this website different from the FDA's post marketing commitments website?
This website provides the current status of Pfizer post marketing commitments listed on the FDA website and includes US post marketing commitments established since August 1, 2000. Information on this website is believed to be correct at the time of posting. The status of post marketing commitments shown on the FDA website may differ from information displayed on this site, due to differences in the timing of updates made to the FDA website. 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 website.
Does this website include post marketing commitments originally made by other companies that Pfizer has acquired?
Yes. Pfizer and its group companies/subsidiaries are the license holders for all medicines listed on this site.
Does Pfizer use the same post marketing commitment status definitions as the FDA?
Yes. Pfizer defines status of its US post marketing commitments using US FDA status definitions. See Post Marketing Commitment Study Status Definitions.
Please refer to EU Status definitions for EU products.
Does this website include European or other country commitments?
This website includes post marketing commitments for medicinal products in the US and in the EU where approved via the Centralized Authorization Procedure only.
Does the European Medicines Agency have a public website on PMCs?
The European Medicines Agency does not have a public website for PMCs. However, information about approval of a medicine is published on the Agency's website as part of the European Public Assessment Report (EPAR) and this can include information regarding PMCs.
How often is this website updated?
This website is updated each month.
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.