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ICH guideline

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SAHPRA-South Africa

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INVIMA-Colombia

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HSA- Singapore

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EMA-Europe

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TGA-Australia

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SFDA-Saudi Arabia

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NA-DFC- Indonesia

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TITCK- Turkey

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USFDA- USA

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MedSafe-Newzeland

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JFDA-Jordan

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KFDA-South Korea

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MOH- Israel

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DGDA-Bangladesh

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EDA-Egypt

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CDE-Taiwan

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EAC- East African Community

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HPFB-Canada

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ANVIZA-Brazil

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ACCSQ-ASEAN Countries

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CFDA-China

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MCAZ- Zimbabwe

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CDSCO-India

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BPFK-Malayisa

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MHSD-Russia

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NDA- Uganda

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PMDA- JAPAN

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ANMAT-Argentina

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FDA,DCD- Thailand

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EEC- Eurasian Economic Union

Introduction

GPExcel HealthCare is launched by the medical scientist working in BABE and clinical trial domain. The group of scientist have 60 years of total men experience in current filed. The main objective provide the link/ guideline under one roof.

Main topic of this collection is Bio-availability / (in-vivo-) Bio-equivalence, although GCP/GLP, dissolution/BCS, pharmacokinetics, bioanalytics and -statistics are covered to some minor extent as well. Linked guidance/guidelines are in English, unless stated otherwise.

Although links to documents are considered current, you should always consult websites of the respective regulatory body for any updated versions.


If you encounter broken links or are acquainted with any missing / updated documents please notify us on gpexcelmp@gmail.com

Disclaimer

Although this Collection contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this Collection should not be considered an exhaustive source of all current applicable laws, regulations, and guidelines in the field. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or ethics committees before starting research activities.

 
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EMEA (European Medicines Agency)

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USFDA U.S Food & Drug Administration

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