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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

UK Industry Skeptical Of Govt’s No-Deal Brexit Filing Expectations

The BioIndustry Association’s latest Brexit webinar looked at issues such as companies’ drug filing strategies in a no-deal scenario as well as the costs that industry is likely to incur as a result of changes to regulatory processes.

United Kingdom Brexit

Australia Considers Identifying Drugs Filed For Approval

The Therapeutic Goods Administration wants to know whether, and how, it should disclose the fact that a medicine has been accepted for regulatory review. It has put several options to stakeholders, including disclosure for all medicines or only certain kinds, or keeping the current practice of “neither confirm nor deny.”
Approvals Drug Review

BIA ‘Reassured’ On Post-Brexit SPC Regime But Data Exclusivity Concerns Remain

The government has said it is prepared to discuss the terms of supplementary protection certificates under a UK-only regime if there is a no-deal Brexit, but concerns also linger over the start dates for regulatory data protection.

Brexit Intellectual Property

UK's NICE Rejects US Industry Attack On Its HTA Methods

The National Institute for Health and Care Excellence does not agree with assertions by the US pharmaceutical industry that its HTA process are “rigid” and “fail to recognize the full value of innovative medicines.”

Pricing Debate Reimbursement

Pushing The Boundaries: The Story Behind MMV’s ‘Pandemic Response Box’

The Medicines for Malaria Venture says it wanted to be "adventurous" in its latest research initiative to generate potential new drugs for pandemic diseases.

Regulation Infectious Diseases

Australia Updates GMP Guidance On Product Release

The Therapeutic Goods Administration gives its interpretation of how the PIC/S Guide to GMP should be interpreted in Australia, covering the roles and responsibilities of the sponsor and the drug manufacturer, as well as the role of the authorized person in product certification.
Manufacturing Australia
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