Author: Pharma Trade Alerts

Regulators clarify study design and data requirements for ANDA submissions, with implications for manufacturers planning 2026 filings.

Health agencies push harmonized reporting standards as cross-border biologic shipments accelerate.

Updated inspection framework targets facilities supplying oral solid forms to regulated markets.

Temporary supply authorizations could shorten timelines when hospitals report stock gaps.

A standardized digital format could reduce customs delays for active pharmaceutical ingredient shipments entering the European Union.

Regional agreement aims to reduce duplicate testing and speed distribution of approved vaccines.

Export data shows sustained demand from European and North American buyers for bulk pharmaceutical ingredients.

European inspectors plan expanded audits of fill-finish facilities supplying hospital injectables.

Federal supply agreement underscores ongoing demand for outpatient antiviral treatments in hospital and retail channels.

Executives emphasize resilient API sourcing and diversified finished-dose manufacturing.