HA & EC Approval Timelines
HA & EC Approval Timelines
- Ethics committee – 4 weeks.
- SAHPRA – 4 to 6 weeks.
- Parallel submissions also allowed for tertiary institutional sites.
- Expedited Approvals – 3 to 6 weeks.
- NB: Sharing protocols expedites the process.
- Provincial DOH’s approvals are now only a notification.
- Ethics committee expedited 2 to 4 weeks.
- PPB – 4 weeks.
- On average: 6 to 8 weeks.
- Expedited options for an extra fee: 3 to 4 weeks.
- Online submissions are starting to gain traction and will become the norm very soon.
- IRB – 4 weeks.
- UNCST – 2 weeks.
- NDA – 12 weeks.
- Expedited options for an extra fee: 3 weeks.
- Online submissions allow for documents to be added online as they become available – allowing the PI to respond to queries in real-time as they occur.
- Commitment from regulatory authorities to review respond within 7 days from submission of any document.
- Parallel Submissions – 6 weeks for final approval.
- Sequential Submissions – 8 to 10 weeks to approval.
- Sequential Submissions – 8 weeks for final approval.
NB: The comments below are based on a dossier for protocol approval. Application for marketing authorization is somewhat different
- Not necessarily the same person. We have had cases where the PI submits to the IRB, and the sponsor submits to the regulatory authorities.
- An accredited vendor may submit on behalf of the sponsor to the regulatory authorities & IRB.
- IRB, however, prefers the submission be done by the PI because IRB prefers to address comments to the investigator.
- Different options available – MERCLINCO also able to conduct all submissions on behalf of Sponsor &/or Investigators if required.
EC and HA submission for conduct of clinical trial is sequential and need to indicate same applicant who will be issued a ‘Permit to conduct clinical trial’. A change can be made through formal application of ‘change of investigator’.
SICRA site is located within Lira Regional Referral Hospital, a large tertiary Hospital serving a population of about 2.5M. The Internal Medicine Department that, chaired by Dr Kiweewa, runs an HIV clinic with a patient load of about 15000 HIV infected patients, that are currently established on HAART. The region has a high burden of the following indications: HIV, TB, Hepatitis B, Malaria, Diabetes, Rheumatic Heart Diseases, COVID-19 and other flu like illnesses. As such SICRA is a potential site for rapid recruitment of participants to clinical studies targeting these indications.
GHANA & NIGERIA
Both have a sequential system of protocol approval, from EC to regulatory approval of clinical trials.
While approval is for a specific protocol and a specific investigator/co-investigator, they also require a change of investigator notification if there is change of protocol oversight. It will therefore not be possible to make parallel submissions to EC and HA by different people unless there is a formal change of investigator, perhaps consider asking ‘a protocol listed co-investigator’ to make submission on behalf of main investigator.