Useful Links
By listing and or use of the Web Resource or Resource links herein, it is understood, by the user, that the Roundtable of Toxicology Consultants (RTC) does not own nor endorse any of the sites listed. These links are provided simply for the convenience of the user and the user accepts responsibility for determining the utility of the content.
Regulatory
Biologics Regulatory Document Library _ Charles River
ICH
US
US FDA | Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
US FDA | Regulations | Laws & Regulations
US EPA | Significant Guidance Documents | Laws & Regulations
US EPA | Policy & Guidance | Laws & Regulations
US FDA | Guidances (Medical Devices and Radiation-Emitting Products)
US FDA | Guidance, Compliance & Regulatory Information (Biologics)
eCFR — Code of Federal Regulations
US FDA | Drug Approvals and Databases
US FDA | Drugs@FDA_ FDA Approved Drug Products
EU
European Medicines Agency – EMA
UK | Human Medicines Regulations 2012
MHRA | Human Medicines Regulations 2012
MHRA | Overview of medicines legislation and guidance
EMA | Human medicines – Regulatory and procedural guidance index
EMA | Regulatory – Human medicines
Canada
Health Canada Drug Product Database (DPD)