BIOLOGICS
Tarius’ highly regarded solution for human biologics covers the complete product life cycle supporting your regulatory strategy planning, clinical trials, product development activities, marketing applications, compliance activities, safety reporting, etc.
1. National Expert Summaries
Tarius’ national expert summaries are original documents written by our network of independent regulatory experts. They provide you with their knowledge and experience about a wealth of operational details and “best practices” in a particular country. The summaries cover all major aspects of the biologic product life cycle from product development to the post-marketing period.
Country by country, following the same table of contents and answering the same set of questions, our Expert Summaries give a general overview of the procedures and requirements related to essential issues such as:
• Definitions of biologics (blood products, vaccines, stem cells, cell therapy,
_gene therapy, monoclonal antibodies, etc.) and who regulates these products
_(if different from drugs)
• How biologics are regulated differently than drugs and what documentation is
_needed to support INDs, CTAs and marketing applications.
• When a biologic can be classified as a medical device or In vitro diagnostic
• Clinical trials, submissions and fees
• Orphan drug designation
• Packaging & labeling requirements
• Pricing & reimbursement
• Approval pathway for biologic generics
• Maintenance of marketing authorizations
• Pharmacovigilance reporting and risk management
• Import and export
• And more.
All expert summaries include a reference section with direct links to the source documents from the national authorities.
2. National Authorities Documents
Tarius monitors national authorities’ websites and national official journals in order to provide draft, current and archive versions of relevant acts, regulations, directives, codes, decisions, policy papers, guidelines, warning letters, press releases, forms, approved product reviews and more. In addition, Tarius monitors a number of important international organizations’ websites, such as ICH, PIC/S, OECD and WHO.
Every document in Tarius contains abstract, keywords and status information in English enabling users to identify important national documents through searching in English, even if they are unfamiliar with the local language.
