Rates - Effective 1 February 2024




Internal Review Non-Compliance

R 2 500.00

New Clinical Trial Application (including Platform or Master Protocols)

R31 500.00

Device Trial Application

R31 500.00

Post Marketing Survey / Registry/ Observational Research / Epidemiological Research / Exploratory Research/ Non-Interventional Research / Environmental Research / Health and Social Care Services Research

R21 500.00

Complimentary Medicines/Cosmetics Research

R21 500.00

Data Analysis

R15 000.00

Genetics / Sub-Study

R 6 000.00

Student Applications

R 10 000.00

Major Amendment

R13 500.00

Minor Amendment

R 4 500.00

Annual Re-Approval

R11 500.00

Sub-Protocol / Cohort to Platform Applications (per protocol/cohort)

R 800.00

Additional Investigators (5 Sites included with initial submission fee)

R 500.00 per every five additional investigators

Amended Informed Consent Documents (non-administrative)

R 500.00

Active Site Monitoring

R1000 p/p, p/h to a maximum of 20 hours.

Pharma-Ethics reserves the right to delay feedback on submissions that do not meet the submission requirements

Included with the initial application fee: Processing and reviewing of Adverse Drug Reactions, Progress Reports, Safety Reports, General Correspondence, Passive Monitoring

An administrative fee of R 50.00 will be charged for re-sending documents.

Withdrawal of applications after submission but before meetings will be charged for costs incurred and a 10 % handling fee.

Please note:

• Pharma-Ethics reserves the right to withhold approval letters until payment is received.
• Purchase Orders (where applicable) must be provided with the application.
• Please quote protocol number/invoice number as reference on electronic payments and e-mail proof of payment to accounts@medpharm.co.za
• Application forms must indicate VAT numbers and details of the company responsible for the account.
• For account queries, please e-mail Ineke Vermeulen: accounts@medpharm.co.za