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.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.

The UK regulator says it wants to come an ‘enabler’ of clinical trials by helping sponsors to deal with potential problems earlier on in the process. 

The European Medicines Agency is looking to increase the review efficiency and consistency of its assessors by experimenting with a US FDA-style approach in which companies can voluntarily submit certain information in advance to facilitate the product’s review.

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.