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April 16, 2018
A new report gives an overview of the work of the International API Inspection Program.
April 11, 2018
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
April 06, 2018
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
April 02, 2018
Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.
March 23, 2018
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
March 19, 2018
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
March 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
March 09, 2018
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
March 06, 2018
This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.
March 02, 2018
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.