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ICMRA Plans Pilot Programs on Hybrid Inspections and Post-Approval Changes

The International Coalition of Medicines Regulatory Authorities (ICMRA) is calling for applications from industry sponsors to take part in two pilot programs that focus on hybrid inspections and collaborative assessments of post-approval changes that involve chemistry, manufacturing and control.

Scheduled to get underway in September 2022, the pilots will focus on developing a common framework for collaborative assessments. One goal is to develop a single list of questions for sponsors or manufacturers, wherever possible, for harmonization across participating regulators.

The FDA and other regulatory authorities are increasingly using hybrid inspections — a mixture of remote monitoring and onsite physical inspections — based on virtual tools developed during the pandemic.

The ICMRA pilot programs are expected to last for one year and reports summarizing the key lessons learnt and recommendations are anticipated by the end of 2023. [FDANews]

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FDA: Hope for user fee reauthorization

While the US Food and Drug Administration has warned that it would need to lay off staff in the first...

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Farmaci biosimilari in Italia: report AIFA aggiornati a maggio 2022

L’Agenzia pubblica i report sul monitoraggio dei farmaci biosimilari in Italia, aggiornati ad maggio 2022. Oltre...

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Impact Factors for Sourcing

How is current market volatility, led by inflationary pressures, supply-chain disruptions, and geopolitical...

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AIFA - Synchron Research Service: il riesame conferma la sospensione di medicinali a causa di irregolarità negli studi

Il Comitato per i medicinali per uso umano (CHMP) dell'EMA ha confermato la propria raccomandazione...

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