Regulatory Submissions

A US application for approval of a generic drug, typically based on bioequivalence to a reference listed drug (RLD) and quality/CMC data, without repeating full clinical efficacy trials.

A yearly report submitted under an IND summarizing study status, safety experience, and progress, typically due within 60 days of the IND anniversary date.

An EU system that allows an API manufacturer to submit confidential active substance information directly to authorities while sharing a non-confidential applicant’s part with the MAH/applicant.

Application to the FDA for permission to introduce a biologic product into interstate commerce. Required for biologics including monoclonal antibodies, vaccines, and gene therapies.

An FDA center responsible for reviewing and regulating most human drugs, including NDAs and many post-approval changes.

A certificate issued by EDQM indicating that the quality of a substance is suitably controlled by the relevant European Pharmacopoeia monograph (with specified conditions).

An FDA order to delay a proposed clinical investigation or suspend an ongoing investigation under an IND.

Application to conduct a clinical trial in a given country. In the EU, submitted to national competent authority and ethics committee; format and content are harmonised.

A confidential FDA submission that provides detailed information (often CMC) about facilities, processes, or materials that can be referenced by multiple applications via a letter of authorization.

DMF type covering drug substance, drug substance intermediate, and/or drug product information (often proprietary CMC details).

DMF type covering packaging materials, including container-closure system components.

DMF type covering excipients, colorants, flavors, essences, and materials used in their preparation.

DMF type for FDA-accepted reference information not covered by DMF Types II–IV (use is limited and must be accepted by FDA).

A US form used for IND submissions and amendments, providing sponsor commitments and administrative information.

A US form commonly used as the application form for NDAs/BLAs and certain supplements, providing key administrative and certification information.

A US certification form related to clinical trial registration and results reporting requirements (FDAAA) used in certain submissions.

A US NDA pathway that relies, at least in part, on published literature or FDA findings for an approved drug, plus new data to bridge differences for the applicant’s product.

A submission to the FDA to request permission to ship and administer an investigational drug in the United States. The IND provides data supporting that the drug is reasonably safe for initial human testing.

A US pediatric development planning document describing planned pediatric studies and requests for waivers/deferrals, submitted during development.

A letter that authorizes a regulator to reference confidential information (e.g., a DMF) on behalf of an applicant/sponsor.

Application to a regulatory authority (e.g. EMA or national CA) to obtain approval to market a medicinal product in that region. Centralised, decentralised, or national procedures apply.

The application submitted to the FDA to obtain approval to market a new drug in the United States. Contains full data on safety, efficacy, CMC, and labeling.

FDA’s publication listing approved drug products with therapeutic equivalence evaluations, and patent/exclusivity information relevant to generic development.

The approved drug product identified by the FDA as the reference for generic drug submissions. ANDAs generally must show bioequivalence to the RLD and match labeling (with permitted differences).

In the US, a submission to an approved NDA or BLA to request a change (e.g. new indication, manufacturing change). Prior Approval Supplement (PAS), CBE-30, or CBE-0 depending on change type.