The European Commission has publish a draft revision of its GMP guidelines on the production of sterile drugs with tweaks to recommendations on clean rooms, sealing technologies and single-use systems.
In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments, the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive...
Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.
The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
The EC says proposals to replace the Clinical Trials Directive with simplified rules will make Europe more attractive for trials, but what do CROs think? Share your opinions in this exclusive Outsourcing-pharma.com poll.
Efforts to sure-up pharma track and trace rules and combat counterfeiting are a significant opportunity for specialist labelling firms, but the pace of change is proving to be a frustration, according to Domino Printing Sciences MD, Nigel Bond.