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Ian Schofield

Edinburgh, U.K
Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs.  As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients. He has a degree in modern languages from the University of Bath. Outside the realm of work, Ian plays guitar in a traditional music group and also enjoys a touch of cycling and gardening. He lives by the seaside about three miles from the centre of Edinburgh.
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Latest From Ian Schofield

Could The EMA Be A Regulatory Model For East Africa?

A meeting between the European Medicines Agency and representatives of the East African Community discussed whether the European agency could act as a model for a regulator in the six-country region.

Regulation Middle East and Africa

SMEs Making The Most Of EU Centralized Procedure And Scientific Support From EMA

Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other support services, and are also proving to be keen users of the agency’s priority medicines scheme (PRIME), accounting for half of all PRIME applications in 2016.

Approvals Regulation

July Deadline For EMA Relocation Bids; Member States Begin Scrutiny Of Proposed Hosting Criteria

The criteria that candidates seeking to host the European Medicines Agency post-Brexit will have to meet are out for discussion among member state representatives and should be finalized towards the end of June. Formal bids will have to be in by July end and a decision on the EMA’s new home should be made in October.

Brexit Europe

AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis

The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.

Drug Review Compliance

All Set For EU Approval: First Biosimilar Humalog And Three More Rituximabs From Celltrion

The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.

Biosimilars Approvals

High Rejection Rate of Proposed Brand Names On EMA Radar

In March, the number of proposed new drug brand names rejected by the European Medicines Agency exceeded those that were accepted. A dedicated group at the agency is to look into the problem at a meeting with stakeholders on June 1.

Trademarks Europe
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