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PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.
The international association of pharmaceutical inspectorates, PIC/S, has developed a structured process that national inspectors can use to assess their risk of exposure to COVID-19 when carrying out routine on-site inspections.
Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.
The World Health Organization says there is a pressing need for guidance on the evaluation of mRNA vaccines because of the rapidity with which clinical trials have progressed for COVID-19 candidate vaccines, their emergency use approval or authorization, and their subsequent widespread use.
Agencies participating in the International Pharmaceutical Regulators Programme discussed priorities, welcomed the UK as the newest IPRP member and endorsed a new regulatory tool to support the assessment of quality-related information in marketing applications.
Headwinds as well as opportunities for the off-patent industry are discussed in a comprehensive new whitepaper by the International Generic and Biosimilar Medicines Association
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.
The European Directorate for the Quality of Medicines & HealthCare, which is responsible for the European Pharmacopoeia, is to be led by former Swissmedic regulator and current World Health Organization executive Petra Dörr.
Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity
MSF is pressuring Moderna and Pfizer/BioNTech to share their vaccine know-how with manufacturers in developing countries, and companies have just a few days to answer the European Commission's questions about COVID-19 therapies they have in development.
International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.
The UK is on a mission to re-join the International Council for Harmonisation as a fully active member with voting rights.
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