Pharma regulation

News

EC clears first treatment for high-risk smouldering multiple...

Johnson & Johnson’s Janssen-Cilag has secured European Commission approval for a new indication of its subcutaneous formulation of DARZALEX

Market Access

The Windsor Framework: Insights on the regulatory shift for ...

The Windsor Framework marks a significant change in the UK's post-Brexit regulatory space, particularly for the pharmaceutical sector

Market Access

Approaching the regulatory world with passion: CERs and EU M...

There has been significant evolution in the European regulatory landscape over the past 10 years, particularly in terms of requirements for clinical evaluation, driven in part by

Market Access

Managing the challenges and embracing the opportunities of E...

The way HTAs are conducted in Europe is changing. And, if organisations act now to overcome the challenges, they could reap the rewards for years to come.

Market Access

DSCSA & dispensers: In the relay race of compliance, how to ...

Leading up to the end of August, I was looking forward to attending the HDA Traceability Seminar in Washington, DC.

News

EC to update IP rules to benefit generic exports

The European Commission (EC) is proposing to adjust intellectual property (IP) rules to help Europe's pharma companies tap into fast-growing global markets.

EC clears first treatment for high-risk smouldering multiple...

The Windsor Framework: Insights on the regulatory shift for ...

Approaching the regulatory world with passion: CERs and EU M...

Managing the challenges and embracing the opportunities of E...

DSCSA & dispensers: In the relay race of compliance, how to ...

EC to update IP rules to benefit generic exports

NHS staff 'feel unprepared for digital transformation'

How to meet your physicians where they are online

Pharma regulation

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