News dal mondo
24
Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for new and existing drug and biologics dossiers to the common technical document (CTD) format described in the International Council for Harmonisation’s (ICH) M4Q(R2) guideline. These were among the many concerns raised by the EU pharmaceutical industry in their feedback submitted in response to the European Medicines Agency’s (EMA) request for comment on the M4Q(R2) guideline. The guideline was published by ICH in May 2025.. [EMA]
27
Apr
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity...
23
Top Drugs at Risk of Supply Shortages
Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...
Regulatory considerations for pharmaceutical excipient selection
The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...
21
TGA clarifies therapeutic goods are unaffected by chemical production and import ban
TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...
le ultime news
06 Feb
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
Computer Software Assurance for Production and Quality Management System Software
04 Feb
FDA, EMA officials encourage companies to pilot eCTD 4.0
03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
02 Feb
USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
29 Gen
US FDA Announces PreCheck Implementation Roadmap
28 Gen
Industry wants more streamlining following recent EU reforms
FDA official offers tips on leveraging AI in drug manufacturing
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