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By:-
Kartik Kamble
Roll no 04
1
 Post marketing surveillance (PMS) is to assure the quality, efficacy and safety of drugs after
they go in the market and to establish proper methods of use of drugs consists of three
systems:-
 The ADRs and infections collection and reporting system,
 The re examination system and
 The revaluation system
The re examination system for new drug was introduces in the October, 1979 amendment of
Pharmaceutical Affairs Law and Good Post marketing Surveillance Practice (GPMSP) came
into effect from April 1993 to assure implementation of PMS and also to assure the reliability
of such PMS data.
2
 GVP (Good Vigilance Practices)
 GPSP (Good Post Marketing Study Practices)
 Paper Compliance Review and On site GPSP surveys of Data for Re examination and Re
evaluation
 Adverse Drug Reactions and Infections Reporting System
 Periodic Infection Report for Biological Products
 Re examination system and
 Re evaluation system
3
 GVP:- It establish standards for post marketing system management related to the collection,
evaluation, and assessment of proper used information on the establishments of appropriate safety
related organization and system as one of licensing requirements for manufacturing, development and
implementation of relevant SOPs, marketed drug, etc. and to the implementation of measures for
safety assurance.
 GPSP:- Specifies items that are to be strictly compiled with in order to achieve appropriate post
marketing surveillance and studies conducted by manufacturing/ marketing authorization holders, and
to assure the reliability of data submitted when applying for re examinations or re evaluation.
 Paper Compliance review and on site GPSP Surveys of Data for re examination and re
evaluation:- Documents and data submitted for re examination and re evaluation of a drug are
subjected to paper compliance review and on site GPSP surveys in order to examine whether the
materials for evaluation have been collected in accordance with the standards specified by the MHLW
minister. Detailed procedure for the compliance review and on site surveys are available as “The
Guidelines On Compliance Paper Reviews On Approval Application Data For New Drugs”
4
 Adverse drug reaction and infections reporting system:- Programs for collecting and reporting
safety information on drug such as ADRs, the drug and medical devices safety information
reporting system undertaken by medical personnel, and WHO International Drug Monitoring
Program where by safety information is exchanged among various countries.
 Periodic Infection Reports for Biological Products:- With the revision of the Pharmaceutical
Affairs Law in July 2002, drugs manufactured from materials derived from humans or other living
organism (excluding plants) that requires caution in terms of public health and hygiene are
designated as biological products by the MHLW. From July 30, 2003, the system of periodic
infection reports was introduced by which manufacturers of such biological products was introduced
by which manufacturers of such biological products. In April 2017, “ Notification On The System
Of Periodic Infection Reports For Regenerative Medicine Products And Biological Products”
5
 Re examination system:- The re examination system is aimed at reconfirmation of clinical
usefulness of drugs by performing GPSP or GVP as one aspect of PMS, through collecting
information on the efficacy and safety of drug during a specified period of time after approval.
This system was commenced in April, 1980. Based on the revision of October 1993, the re
examination period for orphan drugs was extended to a maximum of 10 years.
 Re evaluation:- The re evaluation of drugs is a system where by the efficacy and safety of a
drug, which has already been approved, is considered on the basis of the current status of
medical and pharmaceutical sciences. This new re evaluation of efficacy and safety of all
prescription drugs was started in May,1988. This Re evaluation are at first performed by means
of a review by the PAFSC.
6
Post marketing Surveillance
(PMS) System
GVP, GPSP (GCP)
Adverse drug reaction and
infections reporting system
Drug/ medical device safety information reporting
system by medical personnel
ADR and infectious disease reporting system by
company
WHO international pharmaceutical monitoring
system
Reports of adverse drug reactions from patients
Re examination system
Re examination application
Periodic safety reports- ICH / PBRER
Re evaluation system 7
 www.pmds.go.jp
 www.jpma.or.jp
8

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Post marketing surveillance in Japan, legislation and.pptx

  • 2.  Post marketing surveillance (PMS) is to assure the quality, efficacy and safety of drugs after they go in the market and to establish proper methods of use of drugs consists of three systems:-  The ADRs and infections collection and reporting system,  The re examination system and  The revaluation system The re examination system for new drug was introduces in the October, 1979 amendment of Pharmaceutical Affairs Law and Good Post marketing Surveillance Practice (GPMSP) came into effect from April 1993 to assure implementation of PMS and also to assure the reliability of such PMS data. 2
  • 3.  GVP (Good Vigilance Practices)  GPSP (Good Post Marketing Study Practices)  Paper Compliance Review and On site GPSP surveys of Data for Re examination and Re evaluation  Adverse Drug Reactions and Infections Reporting System  Periodic Infection Report for Biological Products  Re examination system and  Re evaluation system 3
  • 4.  GVP:- It establish standards for post marketing system management related to the collection, evaluation, and assessment of proper used information on the establishments of appropriate safety related organization and system as one of licensing requirements for manufacturing, development and implementation of relevant SOPs, marketed drug, etc. and to the implementation of measures for safety assurance.  GPSP:- Specifies items that are to be strictly compiled with in order to achieve appropriate post marketing surveillance and studies conducted by manufacturing/ marketing authorization holders, and to assure the reliability of data submitted when applying for re examinations or re evaluation.  Paper Compliance review and on site GPSP Surveys of Data for re examination and re evaluation:- Documents and data submitted for re examination and re evaluation of a drug are subjected to paper compliance review and on site GPSP surveys in order to examine whether the materials for evaluation have been collected in accordance with the standards specified by the MHLW minister. Detailed procedure for the compliance review and on site surveys are available as “The Guidelines On Compliance Paper Reviews On Approval Application Data For New Drugs” 4
  • 5.  Adverse drug reaction and infections reporting system:- Programs for collecting and reporting safety information on drug such as ADRs, the drug and medical devices safety information reporting system undertaken by medical personnel, and WHO International Drug Monitoring Program where by safety information is exchanged among various countries.  Periodic Infection Reports for Biological Products:- With the revision of the Pharmaceutical Affairs Law in July 2002, drugs manufactured from materials derived from humans or other living organism (excluding plants) that requires caution in terms of public health and hygiene are designated as biological products by the MHLW. From July 30, 2003, the system of periodic infection reports was introduced by which manufacturers of such biological products was introduced by which manufacturers of such biological products. In April 2017, “ Notification On The System Of Periodic Infection Reports For Regenerative Medicine Products And Biological Products” 5
  • 6.  Re examination system:- The re examination system is aimed at reconfirmation of clinical usefulness of drugs by performing GPSP or GVP as one aspect of PMS, through collecting information on the efficacy and safety of drug during a specified period of time after approval. This system was commenced in April, 1980. Based on the revision of October 1993, the re examination period for orphan drugs was extended to a maximum of 10 years.  Re evaluation:- The re evaluation of drugs is a system where by the efficacy and safety of a drug, which has already been approved, is considered on the basis of the current status of medical and pharmaceutical sciences. This new re evaluation of efficacy and safety of all prescription drugs was started in May,1988. This Re evaluation are at first performed by means of a review by the PAFSC. 6
  • 7. Post marketing Surveillance (PMS) System GVP, GPSP (GCP) Adverse drug reaction and infections reporting system Drug/ medical device safety information reporting system by medical personnel ADR and infectious disease reporting system by company WHO international pharmaceutical monitoring system Reports of adverse drug reactions from patients Re examination system Re examination application Periodic safety reports- ICH / PBRER Re evaluation system 7