Medicines under additional monitoring must be clearly marked

At the end of April the European Medicines Agency published the initial list of medicines subject to additional monitoring, showing ‘an important deliverable of the new European pharmacovigilance legislation’.

Monitoring the issue of medication errors

A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This was the conclusion of the workshop on medication errors organised by the agency last month.

Zetes launches serialisation capability at Propak

Serialisation is the first and crucial step in the product identification and traceability processWhile complete product identification and traceability is a relatively modern concept within supply chain control and management, it has become a strategic consideration for companies that wish to meet food and pharmaceutical safety, legislative or economic imperatives.

Full EU ban on animal testing for cosmetics deadline reached

European Commissioner in charge of Health & Consumer Policy, Tonio BorgAs of the 11th of March 2013, cosmetics tested on animals cannot be marketed any more in the EU.

A Communication adopted by the Commission on the 11th March 2013 confirmed the Commission's commitment to respect the deadline set by Council and Parliament in 2003 and outlined how it intends to further support research and innovation in this area while promoting animal welfare world-wide.

The world’s first (official) biosimilar antibody goes to… Rheumatoid Arthritis


Rheumatoid arthritis

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory officials worldwide it meant more uncertainty and unknowns about proper, global biosimilar guidelines. On 23 July, South Korean biosimilar manufacturer Celltrion announced the approval of Remsima (CT-P13), a biosimilar antibody, by the Korean Food and Drug Administration. Remsima is a biosimilar version of Johnson & Johnson’s Remicade (infliximab) which was one of the first monoclonal antibody TNF inhibitors approved for the treatment of Rheumatoid Arthritis (RA). Remsima is approved for several indications and will be marketed in Asia and South America by the end of the year.

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