Outline of Global Guideline Research Net (GGSN)

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Introduction of Global Guideline Research Net(GGSN)

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The basis for the marketing approval of drug products is safety and efficacy.
To this end, the “ road map “ to develop drug products is both defined and regulated by the regulatory bodies.
You can easily research guideline and related information (abbreviated as guideline) on development of pharmaceutical products by using GGSN.
GGSN covers about 3950 guidelines issued by MHLW (Ministry of Health, Labor and Welfare in Japan), USFDA, EMEA and ICH.

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Outline of Global Guideline Research Net (GGSN)

Linking to guideline and copyright

The guidelines are quoted by linking to the regulatory bodies of MHLW (Ministry of Health, Labor and Welfare, Japan), US FDA, EMEA and ICH based on their policies stated on the following web sites.

Source for guidelines

The guidelines are quoted from linking to the following web-site and references

Japan : MHLW  http://www.mhlw.go.jp/index.html
Data base system for law, ordinance, etc
  • Iyakuhin Seizo Shishin Ordinances and Notification, Jiho, 2001
  • Edited by Society of Japanese Pharmacopoeia, Clinical Evaluation of New Drugs, Yak Nippo, 2004
USA : USFDA  http://www.fda.gov/Human
Europe : EMEA  http://www.emea.europa.eu/ema/
ICH:  http://www.ich.org/cache/compo/276-254-1.html

Classification of guideline and key words

Classification

Pharmaceutical products

Pharmaceutical products are mainly classified into 3 categories, DRUGS, BIOLOGICS,  and Generics.

  • DRUGS:conventional molecules (low molecules)
  • BIOLOGICS:Biological products with high molecules
  • GENERICS:
Region

The guidelines are surveyed from the following regions

  • MHLW: Japan, Ministry of Health, Labor and Welfare
  • USFDA: The United States. Food and Drug Administration
  • EMEA: Europe, European Medicines Agency
  • ICH: International Conference on Harmonization
Field

The fields are classified into the following 4 categories.

  • APPLREVAPR: Application, review, approval, etc
  • EFFICAY: Clinical studies and clinical pharmacology
  • QUALITY: Chemistry, manufacturing and control of drug substances and drug products, biopharmaceutics
  • SAFETY: Non-clinical studies (toxicity, pharmacology, safety pharmacology, pharmacokinetics in animals)

■Number of guideline listed(June, 2013)

PRODUCT
Japan, MHLW
USA, FDA
Europe, EMEA
ICH
DRUGS
710
760
1241
145
BIOLOGICS
131
400
400
15
GENERICS
57
41
41
 -
Total
898
1201
1670
160

Note: Some guidelines are overlapped in different fields

Research of guidelines with key word

Go to “Research Guideline”

Update of GGSN

The GGSN is updated monthly. New guidelines issued during the update and their summary will be periodically introduced at “Update Information of Guidelines “in the top page.

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