Control of Nitrosamine Impurities in Human Drugs

Facility Readiness: Goal Date Decisions Under GDUFA

List of centrally authorised products requiring a notification of a change for update of annexes

Q&A: Good clinical practice (GCP)

Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

Advanced Manufacturing Technologies Designation Program

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

Container Closure System and Component Changes: Glass Vials and Stoppers

Platform Technology Designation Program for Drug Development

Drug Quality Surveillance Program

ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5

Quality Considerations for Topical Ophthalmic Drug Products

Data Quality Framework for EU medicines regulation

Application form - User guide for the electronic application form for a marketing authorisation

Guidance on paediatric submissions

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

Guidance on paediatric submissions

ICH Q3B(R2) QUALITY GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)