This document discusses post-marketing requirements (PMRs) and post-marketing commitments (PMCs) required of drug sponsors after FDA approval. PMRs are studies required by regulation, while PMCs are studies agreed upon between the sponsor and FDA but not required. Sponsors must periodically report on the status of PMRs and PMCs, with certain details like enrollment required for clinical trials. The FDA provides guidance and websites for sponsors to report and check the status of post-marketing studies.

1. D r . R E E N A M A L I K
PMRs/ PMCs

2. Background
 PMRs/PMCs are generally studies or clinical trials that are conducted by
the applicant after FDA has approved or licensed a product for marketing.
These studies or clinical trials can be either required by regulation or
statute (PMR) or agreed upon, in writing, between FDA and the
applicant (PMC).
 Congress addressed concerns by FDA and patient/consumer groups about
the timely completion of agreed-upon PMC studies by applicants in the
FDA Modernization Act of 1997 (FDAMA). Section 130 of FDAMA added
section 506B to the Food, Drug and Cosmetic (FD&C) Act.
 The requirements for annual reporting under 21 CFR 601.70 are limited to
PMCs that concern clinical safety, clinical efficacy, clinical pharmacology
and non-clinical toxicology.
 Note: Tip To Remember
 PMR (as it’s end with R, its required by Regulation).

3. PMRs and PMCs
 Postmarketing requirements (PMRs) – Studies and clinical
trials that sponsors are required to conduct under one or more
statue or regulations
 Postmarketing commitments (PMCs) – Studies or clinical
trials that a sponsor has agreed to conduct, but that are not required
by a statue or regulation.
 “In the past, we have used the word commitment to cover both
required and not required studies and clinical trials. Now, because
commitments and requirements are treated differently under the
law, we are using terminology that distinguishes between studies
and clinical trials that are required and those that a sponsor agrees
to conduct that are not required.”

4. Post-marketing Commitments (PMC)
 Definition: Studies or clinical trials that a sponsor has agreed to conduct,
but that are not required by a statue or regulation.
 When reviewing an NDA, the agency may identify areas that require follow-
up, additional data or a specific activity. If these are not critical enough to
delay or withhold approval for an application (but are considered
significant), the FDA will include them as part of post-marketing
commitments.
 Commitments made during approval negotiations often come post-
marketing commitments (FDA may ask sponsor to do Phase IV, or the
sponsor may volunteer).
 Most NDAs for NMEs have post-marketing commitment requirements.
 FDA expect updates at regular intervals (whether is quarterly or annually)

5. Post-marketing Requirements (PMR)
 Definition: Studies and clinical trials that sponsors
are required to conduct under one or more statue or
regulations
 To view post marketing submissions status for
companies with approved NDA and ANDA from
CDER and CBER, check the following link and enter
the required information:
 http://www.accessdata.fda.gov/scripts/cder/pmc/in
dex.cfm

6. Example
 http://www.accessdata.fda.gov/scripts/cder/pmc/in
dex.cfm

7. Access Data- FDA
 http://www.accessdata.fda.gov/scripts/cder/pmc/in
dex.cfm

8. FDA- Guidance - REPORTING

9. FDA- Guidance - REPORTING
 Except when otherwise provided, an applicant may satisfy its
obligation to “periodically report” on the status of PMRs and
other studies and clinical trials undertaken to investigate a
safety issue by submitting the annual status reports required under
21 CFR 314.81 or 601.70 if the required elements of information
about the status of the PMR information, set forth in section
505(o)(3)(E)(ii), are accurately and completely provided in that
report.
 Therefore, applicants will be able to report on both PMRs and PMCs
at the same time and use the format recommended in the guidance
on the status of PMCs,19 as long as the applicant includes the
required PMR status information, which is described below. On a
case-by-case basis, a PMR may impose an additional obligation to
“periodically report” at specified milestones.

10. PMR Reports
 For each PMR required under FDAAA, the applicant must periodically report on
the status of the study or clinical trial (see section 505(o)(3)(E)(ii)).
 For clinical trials, the report must also include whether enrollment has begun,
the number of participants enrolled, the expected completion date, whether any
difficulties completing the clinical trials have been encountered, and
registration information as required under section 402(j) of the PHS Act (see section
505(o)(3)(E)(ii)).
 We recognize that some of the information required for clinical trial reporting is also
relevant to observational pharmacoepidemiologic studies, and FDA will interpret the
requirement to include this information as applicable to all studies or clinical trials
performed in humans.
 Registration information for clinical trials should include documentation that the PMR is
registered in accordance with Title VIII of FDAAA.

11. PMC Reports
 For each PMC under section 506B of the Act,
applicants are required to report annually on the
status of the studies or clinical trials (21 U.S.C.
356b(a); 21 CFR 314.81(b)(2)(vii) and 601.70(b)).
 The recommendations regarding compliance with
section 506B may be found in the guidance on the
status of PMCs.