Development of Post-Marketing Risk Management Plan Requirements: The Singapore Experience View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-02

AUTHORS

Liesbet Li-Bei Tan, Christine Su-Ching Ho, Phey-Yen Han, Cheng-Leng Chan

ABSTRACT

Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly spontaneous adverse event reporting. As a strategic move towards proactive pharmacovigilance, several drug regulatory agencies have introduced requirements for risk management plans (RMPs) since the early 2000s. The aim of this paper is to share the process on how the Health Sciences Authority (HSA), the national drug regulatory authority of Singapore, conceptualised and implemented its local RMP requirements, drawing upon the experiences of international regulatory agencies. Some of the steps taken include the incorporation of local RMP requirements into HSA’s guidance documents for the pharmaceutical industry, consultation with industry stakeholders on the proposed updates to these requirements, and strengthening of the enforcement of RMP requirements through relevant enactments in legislation. We also compared our requirements with that of other regulatory agencies to ensure that they were aligned with global regulatory standards. Based on our experience in developing the regulatory framework for RMP requirements in Singapore, we put forth recommendations which could be useful for other regulatory agencies embarking on the implementation of RMP requirements in their countries. More... »

PAGES

13-20

References to SciGraph publications

Journal

TITLE

Pharmaceutical Medicine

ISSUE

1

VOLUME

32

Author Affiliations

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40290-017-0219-1

DOI

http://dx.doi.org/10.1007/s40290-017-0219-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1100059394


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1801", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Law", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/18", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Law and Legal Studies", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Health Sciences Authority", 
          "id": "https://www.grid.ac/institutes/grid.413898.f", 
          "name": [
            "Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01, Helios, 138667, Singapore, Singapore"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Tan", 
        "givenName": "Liesbet Li-Bei", 
        "id": "sg:person.01260412432.28", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01260412432.28"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Health Sciences Authority", 
          "id": "https://www.grid.ac/institutes/grid.413898.f", 
          "name": [
            "Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01, Helios, 138667, Singapore, Singapore"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ho", 
        "givenName": "Christine Su-Ching", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Health Sciences Authority", 
          "id": "https://www.grid.ac/institutes/grid.413898.f", 
          "name": [
            "Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01, Helios, 138667, Singapore, Singapore"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Han", 
        "givenName": "Phey-Yen", 
        "id": "sg:person.01301153644.49", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01301153644.49"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Health Sciences Authority", 
          "id": "https://www.grid.ac/institutes/grid.413898.f", 
          "name": [
            "Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01, Helios, 138667, Singapore, Singapore"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Chan", 
        "givenName": "Cheng-Leng", 
        "id": "sg:person.01200563703.74", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01200563703.74"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1038/clpt.2014.184", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1007330232", 
          "https://doi.org/10.1038/clpt.2014.184"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1533/9781908818270.1.25", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1086144645"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2018-02", 
    "datePublishedReg": "2018-02-01", 
    "description": "Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly spontaneous adverse event reporting. As a strategic move towards proactive pharmacovigilance, several drug regulatory agencies have introduced requirements for risk management plans (RMPs) since the early 2000s. The aim of this paper is to share the process on how the Health Sciences Authority (HSA), the national drug regulatory authority of Singapore, conceptualised and implemented its local RMP requirements, drawing upon the experiences of international regulatory agencies. Some of the steps taken include the incorporation of local RMP requirements into HSA\u2019s guidance documents for the pharmaceutical industry, consultation with industry stakeholders on the proposed updates to these requirements, and strengthening of the enforcement of RMP requirements through relevant enactments in legislation. We also compared our requirements with that of other regulatory agencies to ensure that they were aligned with global regulatory standards. Based on our experience in developing the regulatory framework for RMP requirements in Singapore, we put forth recommendations which could be useful for other regulatory agencies embarking on the implementation of RMP requirements in their countries.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1007/s40290-017-0219-1", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1319803", 
        "issn": [
          "1178-2595", 
          "1179-1993"
        ], 
        "name": "Pharmaceutical Medicine", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "32"
      }
    ], 
    "name": "Development of Post-Marketing Risk Management Plan Requirements: The Singapore Experience", 
    "pagination": "13-20", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "88e227d8ff4d5700f2b12c375e4938de29be70dacc028345d5f41bdff354fe0b"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s40290-017-0219-1"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1100059394"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s40290-017-0219-1", 
      "https://app.dimensions.ai/details/publication/pub.1100059394"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-10T20:40", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000001_0000000264/records_8684_00000484.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.1007/s40290-017-0219-1"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s40290-017-0219-1'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s40290-017-0219-1'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s40290-017-0219-1'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s40290-017-0219-1'


 

This table displays all metadata directly associated to this object as RDF triples.

88 TRIPLES      21 PREDICATES      29 URIs      19 LITERALS      7 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s40290-017-0219-1 schema:about anzsrc-for:18
2 anzsrc-for:1801
3 schema:author Nac2053196dba415db220d0ac243c9361
4 schema:citation sg:pub.10.1038/clpt.2014.184
5 https://doi.org/10.1533/9781908818270.1.25
6 schema:datePublished 2018-02
7 schema:datePublishedReg 2018-02-01
8 schema:description Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly spontaneous adverse event reporting. As a strategic move towards proactive pharmacovigilance, several drug regulatory agencies have introduced requirements for risk management plans (RMPs) since the early 2000s. The aim of this paper is to share the process on how the Health Sciences Authority (HSA), the national drug regulatory authority of Singapore, conceptualised and implemented its local RMP requirements, drawing upon the experiences of international regulatory agencies. Some of the steps taken include the incorporation of local RMP requirements into HSA’s guidance documents for the pharmaceutical industry, consultation with industry stakeholders on the proposed updates to these requirements, and strengthening of the enforcement of RMP requirements through relevant enactments in legislation. We also compared our requirements with that of other regulatory agencies to ensure that they were aligned with global regulatory standards. Based on our experience in developing the regulatory framework for RMP requirements in Singapore, we put forth recommendations which could be useful for other regulatory agencies embarking on the implementation of RMP requirements in their countries.
9 schema:genre research_article
10 schema:inLanguage en
11 schema:isAccessibleForFree false
12 schema:isPartOf N5bed3fe60b194956b47b1f71f61e9014
13 N9d36fcca18744dbc903753052cfb3a78
14 sg:journal.1319803
15 schema:name Development of Post-Marketing Risk Management Plan Requirements: The Singapore Experience
16 schema:pagination 13-20
17 schema:productId N1c748300f1aa47c7ba914acfaa46b001
18 Na0dfe3744a8744c1959eaf7324d18bf3
19 Nf2b399657aaf44e1b389fe34513d8a37
20 schema:sameAs https://app.dimensions.ai/details/publication/pub.1100059394
21 https://doi.org/10.1007/s40290-017-0219-1
22 schema:sdDatePublished 2019-04-10T20:40
23 schema:sdLicense https://scigraph.springernature.com/explorer/license/
24 schema:sdPublisher Nb4b8514a7fbc43aab75c0bcb3d164689
25 schema:url http://link.springer.com/10.1007/s40290-017-0219-1
26 sgo:license sg:explorer/license/
27 sgo:sdDataset articles
28 rdf:type schema:ScholarlyArticle
29 N01c6dfb3030a43d6a32c289962a2f786 rdf:first sg:person.01301153644.49
30 rdf:rest N3524a239f8244de8b4ad7e34f94d4138
31 N1c748300f1aa47c7ba914acfaa46b001 schema:name doi
32 schema:value 10.1007/s40290-017-0219-1
33 rdf:type schema:PropertyValue
34 N3524a239f8244de8b4ad7e34f94d4138 rdf:first sg:person.01200563703.74
35 rdf:rest rdf:nil
36 N45993f0b3ab44bd587f65f96eaf54e8a schema:affiliation https://www.grid.ac/institutes/grid.413898.f
37 schema:familyName Ho
38 schema:givenName Christine Su-Ching
39 rdf:type schema:Person
40 N5814aebba1a446769a402cedd9274f55 rdf:first N45993f0b3ab44bd587f65f96eaf54e8a
41 rdf:rest N01c6dfb3030a43d6a32c289962a2f786
42 N5bed3fe60b194956b47b1f71f61e9014 schema:issueNumber 1
43 rdf:type schema:PublicationIssue
44 N9d36fcca18744dbc903753052cfb3a78 schema:volumeNumber 32
45 rdf:type schema:PublicationVolume
46 Na0dfe3744a8744c1959eaf7324d18bf3 schema:name dimensions_id
47 schema:value pub.1100059394
48 rdf:type schema:PropertyValue
49 Nac2053196dba415db220d0ac243c9361 rdf:first sg:person.01260412432.28
50 rdf:rest N5814aebba1a446769a402cedd9274f55
51 Nb4b8514a7fbc43aab75c0bcb3d164689 schema:name Springer Nature - SN SciGraph project
52 rdf:type schema:Organization
53 Nf2b399657aaf44e1b389fe34513d8a37 schema:name readcube_id
54 schema:value 88e227d8ff4d5700f2b12c375e4938de29be70dacc028345d5f41bdff354fe0b
55 rdf:type schema:PropertyValue
56 anzsrc-for:18 schema:inDefinedTermSet anzsrc-for:
57 schema:name Law and Legal Studies
58 rdf:type schema:DefinedTerm
59 anzsrc-for:1801 schema:inDefinedTermSet anzsrc-for:
60 schema:name Law
61 rdf:type schema:DefinedTerm
62 sg:journal.1319803 schema:issn 1178-2595
63 1179-1993
64 schema:name Pharmaceutical Medicine
65 rdf:type schema:Periodical
66 sg:person.01200563703.74 schema:affiliation https://www.grid.ac/institutes/grid.413898.f
67 schema:familyName Chan
68 schema:givenName Cheng-Leng
69 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01200563703.74
70 rdf:type schema:Person
71 sg:person.01260412432.28 schema:affiliation https://www.grid.ac/institutes/grid.413898.f
72 schema:familyName Tan
73 schema:givenName Liesbet Li-Bei
74 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01260412432.28
75 rdf:type schema:Person
76 sg:person.01301153644.49 schema:affiliation https://www.grid.ac/institutes/grid.413898.f
77 schema:familyName Han
78 schema:givenName Phey-Yen
79 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01301153644.49
80 rdf:type schema:Person
81 sg:pub.10.1038/clpt.2014.184 schema:sameAs https://app.dimensions.ai/details/publication/pub.1007330232
82 https://doi.org/10.1038/clpt.2014.184
83 rdf:type schema:CreativeWork
84 https://doi.org/10.1533/9781908818270.1.25 schema:sameAs https://app.dimensions.ai/details/publication/pub.1086144645
85 rdf:type schema:CreativeWork
86 https://www.grid.ac/institutes/grid.413898.f schema:alternateName Health Sciences Authority
87 schema:name Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01, Helios, 138667, Singapore, Singapore
88 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...