Global Pharma Guidance Tracker – July 2020
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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So much will change on the regulatory front next year that the UK drug regulator, the MHRA, has had to issue dozens of new guidance documents to help pharma and biotech firms navigate the new requirements and assessment routes. A key consideration is how the UK will handle centralized EU applications that are still pending on 31 December.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
A first-of-its-kind collaborative study has found that real-world and natural history data are comparable to placebo data from clinical trials in Duchenne muscular dystrophy.