TABLE 4.
Status of implementation of good review practices by SAHPRA.
| Indicator | MCC status a | Comments a | SAHPRA status | Comments | ||
|---|---|---|---|---|---|---|
| Quality measures | ||||||
| Internal quality policy | ✓ | Planned to formally implement | ✓ | Implemented | ||
| Good review practice system | ✓ | Planned to formally implement | ✓ | Improvement required to support timeliness of review | ||
| Standard operating procedures (SOPs) for guidance of assessors | ✓ | Planned to formally implement | ✓ | SOPs for all procedures in the regulatory review to be formalized | ||
| Assessment templates | ✓ | Planned to formalize the use of a single, common template | ✓ | Templates for clinical assessment and abridged and verification reviews have been formally implemented | ||
| Dedicated quality department | ✗ | Establishment of a dedicated quality department is planned | ✓ | Quality manager has been appointed, team to be recruited | ||
| Scientific committee | ✓ | — | ✓ | — | ||
| Shared and joint reviews | ✓ | — | ✓ | — | ||
| Transparency and communication parameters | ||||||
| Feedback to industry on submitted dossiers | ✓ | — | ✓ | — | ||
| Details of technical staff to contact | ✓ | Contact details are made available on an ad-hoc basis | ✓ | Contact details are made available on an ad-hoc basis | ||
| Pre-submission scientific advice to industry | ✓ | Meetings are held with industry on an ad-hoc basis | ✓ | Pre-submission advice is provided for only biologicals and various COVID-19 related applications | ||
| Official guidelines to assist industry | ✓ | — | ✓ | — | ||
| Industry can track progress of applications | ✗ | Implementation of electronic document management system is planned | ✓ | Tracking was implemented for applications in the backlog and BAU process streams | ||
| Publicly available summary basis of approval (SBA) | ✗ | Summary is available but is currently not published | ✗ | ZAPAR not produced or published but planned to implement in future | ||
| Approval times | ✓ | Approval times are not made available to the public | ✓ | Approval times are not made available to the public | ||
| Advisory committee meeting dates | ✓ | — | ✓ | — | ||
| Approval of products | ✓ | — | ✓ | — | ||
| Continuous improvement initiatives | ||||||
| External quality audits | ✓ | External quality audits are not performed routinely | ✓ | External quality audits are now in place | ||
| Internal quality audits | ✗ | Planned | ✓ | Planned to be formally implemented and conducted by the quality department | ||
| Internal tracking systems | ✓ | Implementation of electronic document management system is planned | ✓ | Tracking implemented for applications in the backlog and BAU process streams | ||
| Review of assessors’ feedback | ✓ | — | ✓ | — | ||
| Reviews of stakeholders’ feedback | ✓ | Planned to be formally and routinely reviewed | ✓ | Formally implemented | ||
| Training and education | ||||||
| International workshops/conferences | ✓ | — | ✓ | — | ||
| External courses | ✓ | — | ✓ | — | ||
| In-house courses | ✓ | Training program to be formalized | ✓ | Training program to be formalized and effectiveness of training to be measured | ||
| On-the-job training | ✓ | Training program to be formalized | ✓ | Training program to be formalized and effectiveness of training to be measured | ||
| External speakers invited to the authority | ✓ | — | ✓ | — | ||
| Induction training | ✓ | Training program to be formalized | ✓ | Training program to be formalized and effectiveness of training to be measured | ||
| Sponsorship of post-graduate degrees | ✓ | — | ✓ | — | ||
| Placements and secondments in other regulatory authorities | ✓ | — | ✓ | — | ||
| Legend | Formally implemented | Informally implemented | Not implemented |
a
Adapted from Keyter et al., 2018a.
MCC, Medicines Control Council; SAHPRA, South African Health Products Regulatory Authority; SBA, Summary Basis of Approval; SOP, standard operating procedure, ZAPAR, South African public assessment report.