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A recent report from the US Pharmacopeia (USP) reveals that drug shortages decreased by 23% in 2025; however, the duration of shortages is on the rise. Over 64% of the drugs that are currently in shortage have been unavailable for more than three years, and 39% have been in shortage for over five years.

The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients (APIs) based in India, citing the firms for violations of current good manufacturing practice (cGMP). Additionally, the agency warned a clinical investigator for informed consent, participant screening, and other issues related to the conduct of a clinical trial.

Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.

As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform designed for easy access through a QR code.

The US Food and Drug Administration (FDA) on Tuesday published a warning letter to Indian drugmaker Hikal Limited for supplier evaluation and its handling of complaint investigations. The agency also warned an oncologist for failing to follow clinical trial enrollment protocols and for failing to obtain informed consent from a trial participant.