Drug makers should consider using a key tool in revised guidance on the manufacture of sterile medicinal products in EU nations and most other countries to engage regulatory authorities on risk-based approaches to the nature and timing of implementation, say two industry experts who have closely followed the guideline’s development.
Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect
Experts who led PDA’s interactions with EU, PIC/S and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.
More from Manufacturing
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
• By
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
• By
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
• By
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
More from Compliance
• By
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
• By
Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
• By
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.