Regulatory Terms Starting With E

9 terms in the E index.

• eCTD (Electronic Common Technical Document)

  eCTD is the standard electronic format for pharmaceutical regulatory submissions, organizing CTD content into five modules with a machine-readable backbone so an agency can navigate an application and track every amendment across its lifecycle.

• EIR (Establishment Inspection Report)

  An EIR is FDA's full narrative record of a completed facility inspection, prepared after the investigator leaves and assigning the inspection a classification that determines FDA's next action. The Form 483 lists observations; the EIR evaluates them.

• Elemental Impurity (Elemental Impurity)

  Elemental impurities are inorganic contaminants, principally metals such as arsenic, cadmium, mercury and lead, that reach a drug product from catalysts, drug substances, excipients, water, manufacturing equipment or container closure systems rather than being added for therapeutic benefit.

• EMA (European Medicines Agency)

  EMA is the European Union agency that scientifically evaluates medicines submitted through the centralised procedure and monitors their safety, issuing recommendations on which the European Commission bases legally binding EU-wide authorisation decisions.

• Endotoxin Testing (Endotoxin Testing)

  Endotoxin testing is the quality control assay that quantifies bacterial lipopolysaccharide in parenteral drugs, biologics, and blood-contacting devices, detecting one specific fever-causing contaminant rather than all pyrogens or viable microorganisms.

• eSTAR (electronic Submission Template And Resource)

  eSTAR is FDA's interactive PDF submission template, mandatory for 510(k) and De Novo submissions, that the CDRH Portal rejects until every applicable field and attachment is complete. eSTAR use stays voluntary for PMA, IDE, 513(g), and Q-Submissions.

• EU GMP Annex 11 (Annex 11)

  EU GMP Annex 11 is the EudraLex Volume 4 annex governing computerised systems used in GMP-regulated activities, covering lifecycle risk management, validation, audit trails, access control and periodic evaluation, not only the electronic records and signatures Part 11 addresses.

• Excipient

  An excipient is any component of a drug product other than the active ingredient: the binders, diluents, buffers, coatings and preservatives that carry, stabilize or deliver the drug without pharmacological activity of their own.

• Expanded Access (Expanded Access)

  Expanded access is the FDA-authorized use of an investigational drug, biologic, or device to treat a patient outside a clinical trial, permitted only when the disease is serious or immediately life-threatening and no satisfactory alternative therapy exists.