PIC/S Resumes Assessment Of Countries Seeking To Join Inspection Scheme; Russian Application Frozen For Now
As it prepares to celebrate its 50th anniversary, the international Pharmaceutical Inspection Co-operation Scheme has set out its agenda for 2022, which includes revising its PIC/S GMP Guide and developing an inspection “aide memoire” for tissue and cellular therapy products.
You may also be interested in...
Amid US Cough Syrup Findings, Regulators Feel India Needs To Work On Perceptions But Also Make Improvements
In wake of the furore caused by OTC cough syrups made by two small Indian companies, former and current US FDA and MHRA officials say quality-related issues are not specific to India. However, while image management needs some work, manufacturers in the country also need to make further improvements to ensure quality.
‘Gene Silencing’ Drug Oxlumo Wins English Funding After Alnylam Improves Discount
Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.
New EU Filings
Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.