Intelligence Tools, Links and Resources

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.

Index of Tables
Table 1. RAPS Regulatory Focus Surveillance Tools
This table provides an overview of all RI tools offered by RAPS.
Table 2. Industry, Trade and Professional Regulatory Associations
This table provides an overview of industry associations, trade associations (company membership) and professional associations that provide information for regulatory professionals.
Table 3. Regulatory Alerts, Updates, Newsletters, Journals, Subscriptions and Services
One of the greatest sources of RI can be found in the press and knowing where to find the journals is key.
Table 4. Business Intelligence Websites
This table provides a source of competitive and business intelligence websites.
Table 5. Regulatory Information/Research Providers and RI Sites
If you need help conducting RI or creating a strategic plan, RI providers can assist, but sometimes half the challenge is finding the vendors.
Table 6. Specialized Regulatory Information Databases and Alerts (Paid Subscription)
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.
Table 7. Educational Resources
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.
Table 8. Fee-Based Advisory Committee Updates (Other Than FDA)
This table includes vendors that provide information and updates on the outcome of FDA Advisory Committees.
Table 9. Manufacturing and Quality Health Authority Databases (US and EU)
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.
Table 10. Global Health Authority Orphan Drug Office
If you have any questions about orphan drug designations, this table provides the list of who to contact.
Table 11. Orphan Drug Regulations by Country
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.
Table 12. Orphan Drug Templates and Submission Tips
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.
Table 13. Orphan Drug Product Designation Websites
Want to know if other companies have obtained orphan product designation for the same indication? This table provides the listing of the searchable databases.
Table 14. Orphan Drug Databases and Advocacy Group Information
If you need help with the indication or determining the population prevalence or incidence, the advocacy groups in this table can help.
Table 15. Country Level Clinical Trial Registries
Currently accepted clinical trial endpoints and competitive intelligence can be found on clinical trial registry websites. This table provides a listing of known registries.
Table 16. Global Generic Drug Regulations by Country
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.
Table 17. Global Regulatory Authority Websites
This table provides a listing of regulatory authorities by region.
Table 18. Global Harmonization Efforts
Keeping up on global changes is imperative. This table provides a list of global harmonization initiatives.
Table 19. Approval Information on Medicinal Products by Country/Region
Sometimes the hardest part of creating strategy is locating precedent. This table contains links to approval information by country and region.
Table 20. US Compliance Links
This table includes links to publicly disclosed compliance and inspection information from FDA.
Table 21. Biosimilar Products Regulations, Guidance and Articles by Country
An overview by country of the available regulations and requirements for the development of biosimilar products is provided in this table.

Table 2. Industry, Trade and Professional Regulatory Associations

American Association of Pharmaceutical Scientists
Association of Clinical Research Professionals
Association of Clinical Research Organizations
Biotechnology Industry Organization
Canadian Association of Professional Regulatory Affairs
Canadian Cosmetic, Toiletry and Fragrance Association
The Canadian Generic Pharmaceutical Association
Cosmetics, Toiletry and Fragrance Association
Consumer Health Products Canada
Drug Information Association
Innovation Medicines Canada
European Medical Technology
European Federation of Pharmaceutical Industries and Associations
European Generic Medicines Association
European Association for Bioindustries
European Vaccine Manufacturers
Federation of Pharmaceutical Manufacturers’ Associations of Japan
Food and Drug Law Institute
Generic Pharmaceutical Association
International Federation of Pharmaceutical Manufacturers and Associations
Japanese Pharmaceutical Manufacturer Association
Japanese Self Medication Industry Association
Medical Device Manufacturers Association
National Association of Pharmacy Regulatory Authorities
North Carolina Regulatory Affairs Forum
Orange Country Regulatory Affairs Discussion Group
Parenteral Drug Association
Pharmaceutical Research and Manufacturers of America
Proprietary Association of Great Britain
Pharmaceutical Society of Singapore
Regulatory Affairs Professionals Society
Royal Pharmaceutical Society
The Organization for Professionals in Regulatory Affairs
United States Pharmacy Boards

Table 6. Specialized Regulatory Information Databases and Alerts (Paid Subscription)


Table 8. Fee-Based Advisory Committee Updates (Other Than FDA)


Table 9. Manufacturing and Quality Health Authority Databases (US and EU)

Pharmeuropa provides public inquiries on draft European texts or on matters of general policy, the latest official announcements on freshly adopted monographs, the latest news on pharmacopoeial harmonization and a readers’ tribune.
Pharmeuropa archives
Pharmeuropa Bio and Scientific Notes contains all the news in the biological standardization area and scientific articles linked to the work of the European Pharmacopoeia
Ph.Eur. Reference Standards
Search through a continuously updated database for information on Ph.Eur Reference Standards.
More about Ph.Eur Standards
Place an order
Knowledge is a searchable database of information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; the chromatogram in pdf format; the links to the reference standard catalogue number; the trade names of some reagents, such as chromatography columns and biological kits; and access to the list of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) granted for this substance.
Search Knowledge
Latest Ph.Eur News
Certification Search is a database for information on Certificates of Suitability (CEPs) granted by the EDQM
Certification News
Melclass is a database on the legal classification of medicines regarding their supply: conditions and details of prescription status.

Table 12. Orphan Drug Templates and Submission Tips


Table 14. Orphan Drug Databases and Advocacy Group Information

Organization What They Provide
National Organization for
Rare Disorders (NORD)
Provides a comprehensive summary of a disease (symptoms, causes, population prevalence, related disorders, standard of care [if any], previous orphan drugs already designation and cleared for indication, any investigational therapies, including the patient advocacy groups associated with the disease to help find current literature of other disease information
Rare Disease Information
Patient Organization Database Provides a comprehensive disease summary and prevalence numbers
It also has a drug database where you can input a drug name and it will let you know the global designation status or marketing application approval for an orphan drug. This site is invaluable when mapping out your strategy road map and locating orphan drug information.
Global Orphan Drug Designation Database
EURORDIS (European Rare Disease Organisation) Provides marketing authorizations for orphan drugs
Links to Advocacy Groups, a EURORDIS initiative, is the growing online network of rare disease communities that brings together thousands of patients, families and groups who might otherwise be isolated.
NIH Genetic and Rare Disease Information Provides links to advocacy groups
National Comprehensive Cancer Network Provides links to cancer advocacy groups
List of approved orphan drugs by indication
Rare Disease Report Links to a wide range of advocacy groups

Table 19. Approval Information on Medicinal Products by Country/Region

Australia: AUSPAR
Australia: Consumer Medicine Information
Australia: Register of Therapeutic Goods
Hong Kong: Registered Pharmaceuticals
India: Drugs Approved for Marketing
Japan: Package Insert Database
Japan: Pharmaceutical Reference
Japan: PMDA Review of JNDA
Japan: Risk-Benefit Assessment of Drug Analysis (Drug Information Sheets)
Malaysia: Products Approved at DCA Meetings
New Zealand: Consumer Medicine Info
New Zealand: Data Sheets
Singapore: Online Information Search
Biologics, Radiopharmaceuticals and Genetic Therapies
Drugs and Health Products
Drug and Health Product Register
Drug Product Database Search
Medical Devices
Notice of Compliance
Notice of Compliance with Conditions
Patent Register
Register of Innovative Drugs
Regulatory Decision Summaries
Summary Basis of Decision
Eudrapharm (Product Information for Centrally Authorized Products)
European Medicines Agency—European Public Assessment Reports (EPAR)
MRI Index (Product Information and Public Assessment Reports for Products Authorized via Mutual Recognition Procedure and Decentralized Procedure)
Register of Designated Orphan Products
Belgium Federal Public Service Health (List of Authorized Products and List of Marketing Authorizations Withdrawals)
Czech Republic State Institute for Drug Control (Product Information)
Denmark: Danish Medicines Agency and Price List
Estonia: State Agency of Medicines
Finland: National Agency for Medicines
France: Health Products Safety Agency–Product Information and Public Assessment Reports
Germany: Bundesinstitut Für Arzneimittel Und Medizinprodukte
Greece: Hellenic Association of Pharmaceutical Companies
Iceland: Icelandic Medicines Control Agency
Ireland: Irish Pharmaceutical Healthcare Association Medicines Compendium
Italy: Agenzia Italiana Del Farmaco
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency
Malta: Medicines Authority (Advanced Search)
Netherlands: Medicines Information Data Bank
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Agenzia Espanola de Medicamentos y Produtos Sanitarios (AEMPS)
Sweden: Medical Products Agency
Switzerland: Swissmedic
UK: eMC Website and Medicines and Healthcare Products Regulatory Agency
CBER Approved Biologics (by Year)
CDER Approved NDAs
CDER NME Drug and Biologic Approval Lists
DailyMed (FDA Approved Labeling)
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations