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ICH Guidelines

INTERNATIONAL CONFERENCE ON HARMONISATION (ICH)
What is ICH ?
ICH is a process by which the regulatory authorities of US, the EC, Japan and experts from the pharmaceutical industry and trade associations in the three regions have been brought together.The objective of the process is to discuss scientific and technical aspects of medicinal product registration.
ICH topics and [...]

WHO Stability Guidelines:

WHO has also formulated international regulatory standards on several quality related issues, which include stability, packaging, storage, and bioequivalence. Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions. Further, the establishment of bioequivalence standards between brand and generic drugs is of great importance given [...]

US FDA Stability Guidelines:

US Food and Drug Administration Guidelines:
This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. It does not seek to address the testing for registration [...]

The European Agency for evaluation of Medicinal Products:

The European Agency for evaluation of Medicinal Products:
The guideline addresses the information to be submitted in registration applications for new molecular entities and associated drug products. This guideline does not currently seek to cover the information to be submitted for abbreviated or abridged applications, variations, clinical trial applications, etc.
Specific details of the sampling and testing [...]

AUSTRALIAN REGULATORY GUIDELINES

AUSTRALIAN REGULATORY GUIDELINES: Stability of the Finished Product
Full details of stability testing conducted on the product, together with associated method validation data, must be included with the application.  ARGCM Part I, Section 6, Stability of the Finished Product sets out the requirements for stability data to support the Registration of a complementary medicine. This appendix [...]

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