International Recognition Procedure

International Recognition Procedure From January 2024, the MHRA is adopting the International Recognition Procedure, reflecting a strategic pivot towards an independent and collaborative regulatory framework for swift and secure drug authorizations in the UK. [...]

By |2024-02-01T12:02:52+00:00December 19th, 2023|

EU Health Technology Assessments

Navigating the Future of EU Joint Health Technology Assessments With the Health Technology Assessment (HTA) landscape undergoing transformation in January 2025, it's essential to prepare your pipeline for what lies ahead. Our Market Access [...]

By |2024-02-01T12:02:04+00:00November 2nd, 2023|

PA-NPP Product Uptake By Country

Product Uptake By Country PA-NPPs adhere to strict legislation regarding the supply of unlicensed medicines on an unsolicited request basis. As such, there are many factors that determine the level of uptake in a [...]

By |2024-02-01T12:03:17+00:00November 25th, 2021|

EAP Versus OLE Study

EAP VERSUS OLE Both an Open Label Extension (OLE) and an Expanded Access Program (EAP) can be used to provide continued treatment access after phase 3 clinical trials have ended. To help companies understand [...]

By |2024-02-01T12:01:23+00:00January 20th, 2021|

Sponsor Considerations for EAPs

SPONSOR CONSIDERATIONS FOR EAPs If your company is developing a drug that fulfils an unmet clinical need, you may have already started receiving patient enquiries about expanded access. We have put together this downloadable [...]

By |2024-02-01T12:02:29+00:00December 11th, 2020|

Expanded Access Policy Templates

EXPANDED ACCESS POLICY TEMPLATES If your company is developing a drug that fulfils an unmet clinical need, you may need an Expanded Access Policy on your website. We have provided three templates, one for each [...]

By |2024-02-01T12:02:15+00:00March 5th, 2020|
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