Cross-Country Tables (CCTs)
Tarius Cross-Country Tables (CCTs) let you view a wide range of regulatory data, country by country, helping you to compare, contrast, and better understand how to leverage information across regulatory agencies.
The cross-country tables include more than 950 data cells per country on essential operational details, enabling quick research and comparison of regulatory requests, timelines and fees in each of the countries. In total, more than 85,000 data cells with pertinent information. All tables can be exported into an Excel chart.
The tables cover all of the countries and regions provided by your customized web portal.·
Human Drugs and Biologics CCTs
Tarius provides the following five tables:
CT/IND application requirements, details for clinical labeling contents and language requirements, Ethics Committees, Pediatric Study Requirements, Registry and Results Reporting.
Specific requirements for Clinical PSURs, Clinical SUSARs and Post-Market SUSARs, including regulation references, format, languages and content of individual reports.
Requirements for medicinal products, for example registrations, market authorizations, and variations, including method, timing and amount of payment.
Marketing Authorization Applications
Specific requirements for medicinal products, including timelines, format, contents. Postmarket packaging and labeling, languages, readibility, braille and barcoding requirements.
Orphan designation applications, including orphan definition, format, languages and details of the application.
Good Manufacturing Practices and Good Distribution Practices for medicinal products including areas covered by legislation such as premises, equipment and personnel.
Details concerning Stability requirements, Complaint handling requirements and GMP Inspections.
Medical Devices and IVDs CCTs
Choose between the following six tables:
Types of applications, consultations with authorities, format requirements, pathways, language, electronic gateways, expected review timelines, renewals, pre-inspections, and more. For Packaging/labelling: Registration, languages, control numbers, symbol use, labeling for clinical use, packaging, labeling and packaging for sterile devices, and more.
Class names, determinations, exemptions, pertinent regulations, premarket requirements, databases, and more.
Types of fees, current amounts, currency, payment options and addresses, exemptions, penalties for nonpayment, and more.
Adverse event reporting during CT, Postmarket event reporting, including periodic reporting, device tracking, and recalls.
For import: general requirements, certificates required, labeling, documentation, import for investigational use, pertinent regulations, and more.
For export: general requirements, certificates required, labeling, documentation, export for investigational use, pertinent regulations, and more.
Specific requirements for IVDs including regulation and standards, registration procedures, notified bodies, labeling and trade organizations.