Summary of the Reliance model communicated with a meeting with SAHPRA 9 April 2020, with the Industry Task Force (ITG).
SAHPRA has proactively provided free flowing communication and very helpful information to Industry in response to the COVID-19 situation.
Reliance Model:
There are 35 reliance applications currently being processed:
10 are registered
11 are in evaluation query
8 are in peer review
3 are in primary review
3 are awaiting the response from Applicants
Some RRAs approved the RRA dossiers and some RRAS have rejected these dossiers. Applicants have submitted information for both approvals and rejections to SAHPRA to be as transparent as possible.
SAHPRA can decide on whether to accept or discount the rejections from these RRAs, based on whether the reasons for rejection are applicable to South Africa.
Some Applicants have made multiple reliance applications and not indicated that for example they have submitted 2 dossiers in the same submission and also updated these dossiers with variations.
There is also partial Reliance in these cases with these dossiers having the same API manufacturer, same CEP or same CPQ documents for example.
Action 1:
The Backlog working group of the ITG will revisit the guideline, so that it explicitly explains to Applicants how best to use Reliance in these cases.
- - This discussion will also help to define more clearly the criteria for using Reliance.
The clinical part of dossiers is a major stumbling block with respect to reliance.
SAHPRA also applies Reliance to the clinical part of the dossiers but need a Reliance template to optimize this process.
This clinical Reliance template needs to be simple to best apply this in the clinical part.
Action 2:
SAHPRA to have a separate meeting with the Backlog WG to establish this clinical reliance template.
A follow up meeting to be setup for 16 April 2020 to discuss the above 2 issues with respect to Reliance.
SAHPRA requested that if Applicants are ready to submit their responses, then to do so as soon as possible, rather than waiting until the deadline for submission.
Industry sometimes has an issue with this as the Applicant may have the information. However the internal company processes need to be followed and approval granted by the overseas Corporate Heads before Applicants may submit their responses.
Action 3:
SAHPRA to formally communicate to Industry that they will accept redacted reports and recognize the Mutual Recognition Procedure (MRP) and National Procedure (NP) from countries in the EU
Action 4:
SAHPRA to confirm when the balance of PIs and PILs for resubmission window 6 and all the PIs and PILs for resubmission 7 will be published on the SAHPRA website.
Business as usual (BAU)
Santhani confirmed that BAU is on track with its processes and is up to date with its targets.
The processes are still the same as before, nothing has changed.
Biologicals:
SAHPRA informed the meeting that there are 49 master applications applications= 97 line items that are in the process for registration or rejection.
33 master applications = 61 line items have been registered.
18 master applications = 36 line items have been rejected.
There are 27 master applications to be done, to go through the various processes.
5 masters are newly allocated.
Biologicals is working on a two month timeline to complete these applications but did not commit to a definite date.