Skip to main content
. 2018 May 30;52(4):449–458. doi: 10.1177/2168479018776649

Table 2.

Status of Implementation of Good Review Practices by the MCC.

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