Update on SMC remobilisation
SMC business recovery following the early stages of the COVID-19 pandemic continues to progress well.
The first phase of recovery is now almost complete - nearly half of the submissions in process at the time meetings were suspended in March have been ‘fast-tracked to advice’ following review by the SMC Executive. This approach has minimised delay in patient access as a result of the pandemic.
In the second phase of recovery we have prioritised submissions for medicines with the potential to deliver the greatest benefits for patients – for example medicines for a condition where no other treatment is available, or medicines that are ‘first in class’ in the therapy area.
Moving forward the following steps to expedite decisions, minimise delay and reduce demand on committee members have been agreed. These will be reviewed after six months.
- Medicines accepted by the New Drugs Committee (NDC) will continue to be fast-tracked following SMC executive review, i.e. these submissions will not be considered by SMC.
- Abbreviated submissions will continue to be fast-tracked with a shorter assessment time-line, also following SMC executive review rather than full committee consideration.
- From October 2020, for an interim period due to the COVID-19 pandemic, medicines where alternatives within the same class have previously been accepted for use (or restricted use) by SMC may be eligible for the abbreviated submission process (fast-tracked as above) – updated guidance and submission form are available on the Making a submission webpage.
We are now routinely contacting all companies following regulatory positive opinion to enquire about submission plans. Other companies wishing to submit/resubmit should make contact with the SMC secretariat. Where necessary we may need to prioritise submissions on the basis of clinical need (for example if a high number of submissions is received). Companies are encouraged to make use of the most efficient route for their submission.
Requests for Early Engagement meetings and ultra-orphan proformas are also being considered as normal.
We are mindful that the COVID-19 situation continues to evolve and this may require us to review our approach moving forward.
Please contact our team at email@example.com if you have any queries.