1. DOWNLOAD PROPOSED GUIDELINE ON FEES AMENDMENT HERE:
2. DOWNLOAD COMMENT FORM HERE:
Find below the June 12th proposed fees structure that in Section 3 describes a hefty increase in clinical trial application fees and GCP Inspection fees.
Please provide your comments in the comment form provided in the last box in the attachment below labeled: Comment form 12th June Fees amendment gazette;
To email@example.com by 8th August 2020.
SAHPRA requested a special meeting with Industry Task Group- Business Leadership working group 12/06/2020.
Here is the brief summary of the discussion:
Fees for GMP, GDP, GCP inspection: SAHPRA has proposed to increase the fees and to pay for services rendered
ITG BLWG has provided feedback indicating some key concerns which SAHPRA will now take on review and revert back.
2. Variations fees
The fee payable for major technical variations will be clarified.
Discussed proposal in the insert to the right:
* On the last bullet – considering if possible to a capping the total fee.
* There is a contradiction on the recent Variation amendment guideline which will be retracted and amended.
* ITG proposal on alignment with UK fee structure was taken into account but will be reconsidered.
* Veterinary fees to be taken up with SAAHA separately.
* Biological amendments fees will also be payable.
New fees will also be published soon for comment.
SAHPRA has done extensive benchmarking with SRA and BRICS countries.
The proposal here is being considered.