Human Medicines

Human Medicines

The Authority opened for submission of human medicines applications in February 2020, and veterinary medicines in November 2020. Since then, the influx of human medicines has increased significantly. Submission of Veterinary medicines has been affected by the delay in the finalisation of the VMP listing exercise. This is witnessed with the number of applications submitted for screening (12) and subsequently for registration (2) to date.

Backlog

At inception, BoMRA inherited a backlog from DRU, and below are the numbers of applications inherited. These applications were at different stages of the review process.

Table1: Applications received from the DRU and the backlog status as of the end of Q3 (31st December 2021)

Product Line

No. Inherited

Finalized / Closed

Current Backlog Status

Human medicines applications

400

335

65

Human Medicines Variations

1000

843

157

Complementary medicines applications

685

602

83

Product line No. Inherited Product line No. Inherited
Human medicines applications 400 335 65
Human medicines variations 1000 843 157
Complementary medicine application 685 602 83

The Authority had set a target to reduce the backlog of the applications to 0% by 31st March 2022. This work has been faced with several challenges, that impacted the progress towards meeting the target or more precisely elimination of the DRU backlog. These challenges included but were not limited to:

  1. Human Resources: The department lost some of its key members of staff during the period: Director-DPER, Manager-Human Medicines, Dossier Assessment Specialists
  2. Shift of priorities from the assessment of backlog applications to Covid 19 Vaccine applications
  3. Business disruptions due to Covid 19 pandemic.

 

Below are graphical representations of the status of the applications inherited/received from the DRU as of the end of Q3 (31st December 2021)

Graph 2: Comparison of the current % backlog vs the Q3 backlog target