Singapore's final drug registration guidance to address biosimilars and generics
This article was originally published in SRA
Singapore's Health Sciences Authority has nearly finalised important changes to its guideline on the registration of medicinal products to incorporate, among other things, a new chapter on the registration of biosimilar products and a new fast-track procedure for evaluating generic drug applications1,2.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.
The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these.