Regulatory Terms Starting With E

electronic Common Technical Document (eCTD)

A standardized electronic format for organizing and submitting regulatory applications to health authorities worldwide.

electronic Submission Template And Resource (eSTAR)

FDA's interactive PDF template required for all 510(k) submissions and extended to De Novo classification requests.

Elemental Impurity (Elemental Impurity)

Inorganic impurities, principally heavy metals, that may be present in drug products and require assessment under ICH Q3D.

Endotoxin Testing (Endotoxin Testing)

Analytical testing to quantify bacterial endotoxins in parenteral drugs, medical devices, and other products where endotoxin presence could cause pyrogenic reaction.

Establishment Inspection Report (EIR)

The formal written report FDA issues at the conclusion of a facility inspection documenting findings and classification.

EU GMP Annex 1 (Annex 1)

The EU GMP annex establishing requirements for the manufacture of sterile medicinal products.

EU GMP Annex 11 (Annex 11)

The EU GMP annex establishing requirements for computerized systems used in GMP-regulated activities.

European Medicines Agency (EMA)

The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

Excipient

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

Expanded Access (Expanded Access)

The pathway for patients with serious or immediately life-threatening diseases to access investigational medical products outside of clinical trials.