Rules for Guidance Extraction and Updates

Guidance’s Document Collection

Guidance’s Document Update

Documents are crawled from the official pages for the FDA sub-categories:

• Advisory Committees
• Biologics
• Clinical Trials
• Combination Products
• Drugs *
• Medical Devices

*Product-Specific Guidance’s for Generic Drug Development (Bioequivalence Recommendations) are excluded

Documents are updated monthly based on the following criteria:

• Validation of metadata, including issue date and status
• Removal of duplicate documents across categories, including ICH guidelines listed under FDA subcategories
• Removal of outdated documents, such as draft guidelines that have been superseded by finalized versions
• Where available, draft guidance issued after and intended to supersede the current guidance is stored alongside the current guidance

Guidance’s Document Collection

Guidance’s Document Update

Documents are crawled from the official pages for the EMA sub-categories:

• Biological guidelines
• Clinical efficacy and safety guidelines
• Clinical pharmacology and pharmacokinetics
• Multidisciplinary guidelines
• Non clinical guidelines
• Quality of medicines Q&A -Introduction
• Quality guidelines

For each above section the current effective versions of the guidance’s documents are collected with the relevant meta data: reference id, legal effective date and status

Points to consider, reflection papers, concept papers, public statements and Q&A files present under the current effective versions are included

Documents are updated monthly based on the following criteria:

• Validation of metadata including status, legal effective date, and reference ID for documents where metadata is available
• Removal of duplicate documents across categories, including ICH guidelines published under EMA subcategories
• Removal of outdated documents when a draft guideline (open for consultation) is finalized and adopted as the current guideline; all previous versions are removed
• Draft guidelines that are open for consultation are maintained alongside the current effective guidelines, where available

Guidance’s Document Collection

Guidance’s Document Update

Documents are crawled from the official pages for the ICH sub-categories:

• Quality Guidelines
• Safety Guidelines
• Efficacy Guidelines
• Multidisciplinary guidelines

For each above section, documents are downloaded into the relevant sub-categories. Next to the guidelines, endorsed documents, Questions and Answers, WG presentations/Trainings associated with the topic are collected in pdf format.

Documents are updated monthly based on the following criteria:

• Validation of metadata such as status and date for documents where metadata is available
• Removal of duplicate documents across categories, including subcategories of ICH guidelines
• Addition of new documents when they become available on the official ICH website
• Removal of outdated documents when updated versions are published on the official ICH website