Regulatory and Compliance Databases
PharmTech compiled a list of useful regulatory and compliance databases found on the web.
Searchable Databases
US FDA
Adverse Event Reporting System (AERS)
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Bioresearch Monitoring Information System (BMIS)
Clinical Investigator Inspection List (CLIIL)
Current Good Manufacturing Practice (CGMP) Regulations
Dissolution Methods for Drug Products
Drug Firm Annual Registration Status
Inactive Ingredient Search for Approved Drug Products
Postmarket Requirements and Commitments
EDQM
Supplier andMaterial Certification Database
EU
ICH
ICH's Library ofPresentations and Training Materials, Concept Papers & Business Plans, Guidelines, Questions& Answers, and more.
PQRI
Risk-managing training tools from the Product Quality Research Institute
USP
USP's Medicines Quality Database
SFDA
State Food and Drug Administration, P.R. China
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
