The rumours are still out there about not talking to regulators: they will “just say no”. It’s such a shame we are still hearing this, particularly about the use of complex innovative trial designs, such as basket and umbrella trials, …
A variation allows the applicant to apply for changes to a marketing authorisation. Changes are classed either as minor changes which include Type 1A or Type 1B variations, or as a major change classed as a Type II.
The Product Information Quality Unit (PIQU) team often gets asked for help during a Type 1B variation procedure. This ranges from providing advice on missing documents to explaining why the proposed changes are not acceptable first time around.
If you’re working to develop and submit applications to MHRA for marketing authorisations and clinical trial authorisations, then you need to keep up to date with the latest regulatory thinking and be able to easily find tips and tricks to avoid common pitfalls.