2. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS2
1. Post marketing surveillance, means obtaining information about a product after it has been
approved for public use.
2. Section 505 A (3) authorizes FDA to require certain PMS studies & clinical trials for
prescription drugs approved under section 505 (B) & biological product approved under
section 351.
3. Post marketing surveillance of drug therefore play an important role to discover an
undesirable effect that might present at risk.
4. It provides additional information on the benefit and risk of the drugs.
5. Post-marketing surveillance (PMS) to assure the quality, efficacy and safety of drugs after
marketing and any other information required for the proper use of drugs consists of three
systems: the ADRs and infections collection and reporting system, the reexamination system
and the reevaluation system.
3. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS3
Post-market surveillance (PMS) is defined as "a systematic process to derive necessary
corrective and preventive actions (CAPA) from information on medical devices already placed
on the market".
Post marketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or
medical device after it has been released on the market and is an important part of the science
of pharmacovigilance.
4. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS4
1. To supervise the safety management supervisor.
2. To respect the opinions of the safety management supervisor.
3. To assure close coordination with the safety management supervisor, quality assurance
supervisor, and other persons involved in safety management.
4. To closely collaborate with the supervisor of post-marketing surveys, etc. in implementing
the RMP.
5. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS5
1. Safety management department: A department meeting the following requirements must be
established to handle all duties related to safety assurance.
a. This department is under the supervision of the general manufacturing/marketing supervisor.
b. This department must employ adequately qualified and competent personnel who are able to
undertake safety assurance activities properly and smoothly.
c. This department should be independent of all divisions responsible for marketing drugs and other
departments that would hinder proper and smooth safety assurance activities.
2. Safety management supervisor: meeting the following requirements must be appointed.
a. Supervisor of the safety management department.
b. This supervisor must have been engaged for at least 3 years in safety
c. This supervisor must have the ability to properly and smoothly undertake safety assurance activities.
d. This supervisor must not belong to any division responsible for marketing drugs, etc.
3. Safety management implementation supervisor: When part of the safety assurance activities are
undertaken by persons other than the safety management supervisor, a supervisor of the work
concerned must be appointed.
6. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS6
1. The following standard operating procedures for post-marketing safety management must be
prepared.
Procedures
for collection of safety
management
information (SMI)
for in-house inspections
for education and training
retention of
records
necessary for properly and
smoothly implementing
SAM
Collaborating with the
supervisors when the RMP is
required in practice
Implementation of
safety assurance
measures (SAM)
implementing the
when the RMP is
required in practice.
for reporting from SMS to
general marketing
compliance officer
reporting from SMI
supervisor to safety
management supervisors
(SMS)
drafting of SAM based
on examination of SMI.
7. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS7
2. The duties and management system: for persons employed for work related to post-marketing
safety management must be specified in writing.
3. Items required for proper and smooth implementation of safety assurance activities: must be
specified in writing.
4. When the procedures in [1] or the documents in [2] and [3] are prepared or revised, they must
be dated and retained.
5. The general marketing compliance officer shall make available the procedures in [1], the
documents in [2] and [3] and other documents required for safety assurance work in the office
performing the work and also must make available copies of procedures and other related
documents in other offices performing safety assurance work.
8. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS8
Overall supervision of safety assurance work
Confirmation that safety assurance work is being performed properly and smoothly
and preparation and retention of records of such confirmation
Offering of opinions in writing to general marketing compliance supervisor when
safety assurance work is required and retention of copies of such opinions
To closely collaborate with the supervisor of post-marketing surveys, etc. in
implementing the RMP.
9. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS9
1. The following safety management information shall be collected by the safety management supervisor
and safety management implementation supervisor and records thereof shall be prepared.
a. Information from health professionals
b. Information on reports presented at scientific meetings, reports from the literature and other research reports
c. Information from the Ministry of Health, Labour and Welfare, other government institutions, prefectural
governments and PMDA
d. Information from foreign governments and overseas organizations
e. Information from other pharmaceutical manufacturing/marketing authorization holders
f. Other safety management information
2. The safety management implementation supervisor shall report the records in [1] in writing to the
safety management supervisor.
3. The safety management supervisor shall preserve the records in [1] and reports in [2]
10. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS10
1. The safety management supervisor shall perform the following duties:
1) Examine the collected SMI without delay and record the results thereof.
2) Supply all safety information that the quality assurance supervisor must be familiar with in writing without
delay to the quality assurance supervisor.
3) When it is confirmed necessary from an examination of safety management information, measures shall be
drafted to discard, recall or suspend marketing of the product, revise package inserts, supply information to
health professionals by persons in charge of drug or medical device information, reports to the Minister of
Health, Labour and Welfare and other safety assurance measures.
4) Drafts of SAM shall be reported in writing to the general marketing compliance officer and copies shall be
retained.
2. When the SMS has the safety management implementation supervisor examine SMI, he or she shall
issue instructions in writing and retain a copy.
3. Records of the examination performed by the safety management implementation supervisor shall be
prepared and reported in writing.
4. The SMS shall retain these results.
11. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS11
1. The general marketing compliance officer must undertake the following duties:
a. Appropriately evaluate drafts of SAM, decide the SAM to be taken and prepare and retain records thereof.
b. When SMS undertake SAM, instructions shall be issued in writing and retained.
c. When safety management implementation supervisors undertake SAM, instructions shall be issued in
writing and the SMS shall retain copies. The safety management implementation supervisor shall prepare
records and make reports in writing. The copies shall be given to the SMS.
2. The safety management supervisor shall perform the following duties:
a. SAM shall be undertaken based on instructions from the general marketing compliance officer and records
thereof shall be prepared and retained.
b. When SAM are undertaken by safety management implementation supervisors, instruction shall be issued in
writing and copies shall be retained. Records shall be prepared, reported in writing and retained.
c. The results of implementation of SAM shall be reported in writing to the general marketing compliance
officer, and copies shall be retained.
d. Copies of reports from the safety management implementation supervisor shall be retained.
3. Evaluation of drafts of SAM for which post-marketing safety management SOP have been specified
beforehand, deciding on SAM to be taken, and preparation and retention of records can be
undertaken by the SMS in place of the general manufacturing/marketing supervisor.
12. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS12
PMS is the practice of monitoring the safety of a pharmaceutical drug.
Drugs after it has been released on the market and is an important part of the science of
pharmacovigilance.
Since drugs approved on the clinical trials which involve relatively small numbers of people who have
been selected for this purpose.
In 1960 at least two serious drugs reaction were observed in many patient. thalidomide causes limbs
deformities (phocomelia).
PMS senator Edward Kennay suggested that a better system was need for monitoring the use and
effects of prescription drugs after they are marketed.
Delayed discovery of the adverse effects spurred effects to improve post marketing survillence.
13. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS13
The primary objective of post marketing studies: is to develop information about drug effects under
customary conditions of drug use. Initial clues about a drug’s potential effects come from the experimental
studies carried out with both animals and humans in the premarketing period. Spontaneous or voluntary
reporting (e. g., in letters to the editors of medical journals) is the oldest, and to-date, the most productive
source of new in- formation about a drug’s possible effects once a drug is marketed. Other types of studies are
used to examine in more detail the possible effects of a drug. In general, these other types of studies use either
cohort or case-control methods
Thus, four types of studies are generally used to identify drug effects:
1. Controlled clinical trials,
2. Spontaneous or voluntary reporting
3. Cohort studies, and
4. Case-control studies
14. 5/20/2019
DR G.K.SHARMA PHARMD, MDIA, CPPM, CGCP, CCP, RPH, PGDRC,
PGDPH, DCMS14
Controlled clinical trials match treatment and control groups as closely as possible , minimize bias through such
methods as randomization and double–blinding and directly monitor patients for the duration of study.
Controlled clinical trials are considered the most definitive method for evaluating a drug’s efficacy and safety, but they
are often costly or impractical in specific situations, for example ,when a drug’s effects are rare or appear only after
long‐term use or a long latency period.
Spontaneous or voluntary reporting: Voluntary reporting By physicians and other health care providers, Hospital
and consumers may act to alert FDA and pharmaceutical firms to possible adverse effects of drugs.
Cohort studies: Cohort studies follow a defined group of patients for a period of time . In this method , patients are
not randomly assigned to groups , and there is no blinding . Cohort studies are usually prospective and observe the
cohort from the beginning of drug use.
A group of patients taking the drug of interest is assembled and followed.
A second group of patients (the control ) with the same medical conditions, who are not taking the drug and who may
receive alternative treatment, but who are otherwise matched as closely as possible with the cohort , may also be
studied in parallel.
Case‐controlled studies: identify patients with the adverse effects to be studied and compare them with the sample ,
drawn from the cohort that give rise to the cases.
