The first step to create Regulatory Intelligence is to find the raw regulatory information. Below are tools to help launch your navigation to global regulatory information sites.
This table provides an overview of all RI tools offered by RAPS.
This table provides an overview of industry associations, trade associations (company membership) and professional associations that provide information for regulatory professionals.
One of the greatest sources of RI can be found in the press and knowing where to find the journals is key.
This table provides a source of competitive and business intelligence websites.
If you need help conducting RI or creating a strategic plan, RI providers can assist, but sometimes half the challenge is finding the vendors.
Sometimes you need help and assistance in your RI needs and an RI database provider can be the answer, but first you have to evaluate them and understand what each contributes. The first step, like everything else in RI, is knowing where to find the vendor or information.
When you want to learn a new skill, or expand your current knowledge base, you need to know where to find educational training. Table 7 includes both vendors and Health Authority (HA) offerings.
This table includes vendors that provide information and updates on the outcome of FDA Advisory Committees.
This table provides some little-known manufacturing information sites that RI professionals will find helpful in searching for drug master files or other quality information.
If you have any questions about orphan drug designations, this table provides the list of who to contact.
When you have an orphan drug, you need to know all the orphan drug regulations around the globe and how they compare so you can create and submit an orphan drug designation/application.
Even though orphan drug submissions use the same name, their actual requirements differ by country. This table provides the templates for some orphan drug submissions.
Want to know if other companies have obtained orphan product designation for the same indication? This table provides the listing of the searchable databases.
If you need help with the indication or determining the population prevalence or incidence, the advocacy groups in this table can help.
Currently accepted clinical trial endpoints and competitive intelligence can be found on clinical trial registry websites. This table provides a listing of known registries.
When you are planning a generic drug submission, it is important to know all the regulations to plan the submission and how the applications differ by country.
This table provides a listing of regulatory authorities by region.
Keeping up on global changes is imperative. This table provides a list of global harmonization initiatives.
Sometimes the hardest part of creating strategy is locating precedent. This table contains links to approval information by country and region.
This table includes links to publicly disclosed compliance and inspection information from FDA.
An overview by country of the available regulations and requirements for the development of biosimilar products is provided in this table.
Table 1. RAPS Regulatory Focus Surveillance Tools
Table 2. Industry, Trade and Professional Regulatory Associations
Table 3. Regulatory Alerts, Updates, Newsletters, Journals, Subscriptions and Services
Table 4. Business Intelligence Websites
Table 5. Regulatory Information/Research Providers and RI Sites
Table 6. Specialized Regulatory Information Databases and Alerts (Paid Subscription)
Table 7. Educational Resources
Table 8. Fee-Based Advisory Committee Updates (Other Than FDA)
Table 9. Manufacturing and Quality Health Authority Databases (US and EU)
Table 10. Global Health Authority Orphan Drug Office
Table 11. Orphan Drug Regulations by Country
Table 12. Orphan Drug Templates and Submission Tips
Table 13. Orphan Drug Product Designation Websites
Table 14. Orphan Drug Databases and Advocacy Group Information
Table 15. Country Level Clinical Trial Registries
Table 16. Global Generic Drug Regulations by Country
Table 17. Global Regulatory Authority Websites
Table 18. Global Harmonization Efforts
Table 19. Approval Information on Medicinal Products by Country/Region
Table 20. US Compliance Links
Table 21. Biotherapeutic Products Regulations, Guidance and Articles by Country