International Information

Canada
EMEA
European Customs Inventory of Chemical Substances
International Nonproprietary Names for Pharmaceutical Substances
International Union of Pure and Applied Chemistry (IUPAC)

- CANADA

The files contained at the two sites given below are in the form of compressed WordPerfect files. To access them, download the file, "unzip", i.e. uncompress the files, and read with WordPerfect or WORD. If you use WORD, the uncompressed files can be saved as a WORD document.

DP-Web: Policies - this is a broad-based site with information on advertising, CMC format, labeling issues, and notifiable changes.
DP-Web: Guidelines - included in this site are the following. The site should be examined for all content.
GMPs
Site Reference File

EUDRA/EMEA now offers a subscription option to receive internet notification of new information.

ICH Guidelines from EUDRA/EMEA

EUDRA/EMEA - this site contains some recently final adopted versions of ICH guidelines as well as some new drafts
Pharmweb offers another site with information on the ICH process and its guidances.

Note for Guidance on Photostability testing of New Active Substances and Medicinal products(CPMP adopted December 96)

Note for Guidance on Stability Testing: Requirements for New Dosage Forms(CPMP adopted December 96)

Note for Guidance on Impurities in New Medicinal Products(CPMP adopted December 96

Note for Guidance on Validation of Analytical Procedures: Methodology(CPMP adopted December 96)

Annex to Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products (CPMP/ICH/380/95): Reduced Stability Testing - Bracketing and Matrixing

Note for guidance on impurities: residual solvents (see October 1996, Pharmaceutical Technology for a dsicussion)

Note for guidance on development pharmaceutics

Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products

Annex to Note for Guidance (CPMP/QWP/486/95): Start of Shelf Life of the Finished Dosage Form.

Annex to Note for Guidance CPMP/ICH/380/95: Maximum Shelf Life for Sterile Products after First Opening or following Reconstitution.

Note for Guidance on Photostability Testing of New Drug Substances and Products

Note for Guidance on Stability Testing Requirements for New Dosage Forms

Bracketing and matrixing of stability studies

Note for Guidance on Validation of Analytical Methods: Methodology

Note for Guidance on Impurities in New Drug Products

International Nonproprietary Names for Pharmaceutical Substances

World Health Organiztion (WHO) is the body that coordinates the issuance of International Nonproprietary Names

European Customs Inventory of Chemical Substances

ECICS contains some 34,800 chemical names (approximately 28,300 products), in nine Community languages (with the exception of Swedish and Finnish, which are not yet available), together with their tariff classifications in the European Community's Combined Nomenclature (CN, 8 digit classification-codes). The CN is based on the "Harmonized Commodity Description and Coding System" which is used worldwide.

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