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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. However, pharmaceutical companies have faced many different problems to be solved during drug development.
Regulatory Science Institute, Inc. (RSI) provides services on research /survey of regulations and consultancy on drug development to help pharmaceutical companies solve problems, and conduct more scientific and efficient drug development, |
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Guideline Search : Guideline Global Search Net (GGSN) |
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Last Update 2008/12/17 |
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You can easily search Guidelines and related information (abbreviated as Guidelines) on development of pharmaceutical products by using GGSN
GGSN covers about 1800 Guidelines issued by MHLW (Ministry of Health, Labor and Welfare in Japan), USFDA, EMEA and ICH. Pharmaceutical products are classified into main 2 categories, DRUGS (conventional molecules) and BIOLOGICS (biological products with high molecular molecules) with GENERICS.
The Guidelines are classified into the following 4 fields.
- APPLREVAPR: Application, review, approval, etc
- EFFICACY: Clinical studies
- QUALITY: Control, manufacturing and control of drug substances and drug products, etc
- SAFETY: Nonclinical studies (toxicology, pharmacology, safety pharmacology, pharmacokinetics)
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Seminar |
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RSI provides seminars focusing on the following topics by experts in fields.
- Strategy on drug development from drug discovery to marketing approval
- Globalization of drug development
- Regulatory topics on drug development
- Others
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Consultation |
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RSI provide the following consultancy services to help sponsors conduct efficient drug development and solve issues.
Research and survey of regulations on drug development
- Drug development : IND application, preclinical studies and clinical pharmacology
- Outsourcing: efficient outsourcing, selection of CRO,
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Date of update 2008/12/24 |
Regulatory Science Institute, Inc. provides new issued Guideline’s and its brief summary
▼DRUGS
■MHLW
APPLREVAR 9
EFFICACY 6
QUALITY 3
SAFETY 3
■USFDA
APPLREVAR 12
EFFICACY 6
QUALITY 9
SAFETY 5
■EMEA
APPLREVAR 16
EFFICACY 43
QUALITY 13
SAFETY 5
■ICH
APPLREVAR 2
EFFICACY 2
QUALITY 7
SAFETY 1
▼BIOLOGICS
■MHLW
APPLREVAR 3
SAFETY 1
■USFDA
APPLREVAR 7
EFFICACY 2
QUALITY 2
SAFETY 2
■EMEA
APPLREVAR 2
EFFICACY 6
QUALITY 4
SAFETY 1
▼GENERICS
■EMEA
EFFICACY 1
Go to the detail of Guideline update information |
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