Expert Summaries


Tarius’ Expert Summaries guide you through local submission procedures, reporting requirements and best practices via English summaries of local hands-on experience written by regulatory professionals. The summaries provide descriptions of the implementation of the national legislation and international guidelines for each of the countries covered by Tarius, allowing you to make an immediate judgment about a particular country’s needs and formulate a country-specific regulatory strategy.

The summaries are written exclusively for our customers by our global network of trusted, independent regulatory in-country consultants.

Tarius has defined a detailed Table of Content for each of the Expert Summaries to ensure consistency across countries and that we continuously meet the needs of the industry for relevant, correct and comprehensive information. In total, more than 4.000 summaries are available for Tarius’ customers.


Expert Summaries: Drugs and Biologics

More than 20 summaries for human drugs and biologics per country describe the national regulatory setup for:

Scientific Advice
Clinical Trials
Marketing Authorization Applications (MAAs)
Maintenance – post approval
Fees
Orphan Drug Designation
Packaging and Labeling Requirements
Pricing and Reimbursement
Pharmacovigilance Reporting Procedures
Import and Export
Advertising
Sale to Consumers
National Authorities
Industry Associations
Compassionate Use
OTC Switch.

Expert Summaries: Medical Devices, IVDs

More than 20 summaries for medical devices and IVDs per country describe the national regulatory setup for:

Medical Device Classification
Quality Systems Requirements
Clinical Trials
Marketing Approval
Establishment Registration
Packaging and Labeling Requirements
Reporting
Recalls
Advertising
Device Tracking
Inspection of Manufacturing Sites
Sale to Consumers
Data Protection
Import and Export
Pricing and Reimbursement
Enforcement
Regulatory Authorities.