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Global Pharma Guidance Tracker – September 2020

Executive Summary

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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UK’s First Real-World Evidence Guideline Targets Randomized Trials

The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Next To No Uptake On UK Patient Preference Study Advice

More than a year after UK health technology assessment body NICE started offering scientific advice on designing patient preference studies, only two companies have sought guidance. NICE has also contributed to related projects that it hopes will increase the relevance of such studies in the context of an HTA appraisal.

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