Table 2.
Indicator | Status | Comments | |
---|---|---|---|
Quality measures | |||
Internal quality policy | ✓ | Planned to formally implement | |
Good review practice system | ✓ | Planned to formally implement | |
Standard operating procedures for guidance of assessors | ✓ | Planned to formally implement | |
Assessment templates | ✓ | Planned to formalize the use of a single, common template | |
Dedicated quality department | ✗ | Establishment of a dedicated quality department is planned | |
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 | |
Presubmission scientific advice to industry | ✓ | Meetings are held with industry on an ad hoc basis | |
Official guidelines to assist industry | ✓ | ||
Industry can track progress of applications | ✗ | Implementation of electronic document management system is planned | |
Publicly available Summary Basis of Approval (SBA) | ✗ | Summary is available but is currently not published | |
Approval times | ✓ | 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 | |
Internal quality audits | ✗ | Planned | |
Internal tracking systems | ✓ | Implementation of electronic document management system is planned | |
Review of assessors’ feedback | ✓ | ||
Reviews of stakeholders’ feedback | ✓ | Planned to be formally and routinely reviewed | |
Training and education | |||
International workshops/conferences | ✓ | ||
External courses | ✓ | ||
In-house courses | ✓ | Training program to be formalized | |
On-the-job training | ✓ | Training program to be formalized | |
External speakers invited to the authority | ✓ | ||
Induction training | ✓ | Training program to be formalized | |
Sponsorship of postgraduate degrees | ✓ | ||
Placements and secondments in other regulatory authorities | ✓ |
▪ Formally implemented
▪ Informally implemented
▪ Not implemented