Operationalise a Fully Functional Regulatory System

BoMRA is targeting to be at WHO maturity level 3 (ML3) where 8 core regulatory functions will be operational and meet the criteria and standards set. The Authority will conduct annual WHO Global Benchmarking (GBT) self-assessments and final WHO assessments to reach ML3.

BoMRA develops and Implements the Institutional Development Plan (IDP), addressing identified gaps and interventions required as per the WHO Global Benchmarking Tool. The core functions are as follows:

  1. Enhance its registration functions to ensure that medical and veterinary pharmaceutical products and related substances are registered and meet the efficacy, quality and safety standards
  2. Enhance clinical trials controls to ensure good pharmaceutical processes are adhered to
  3. Establish post-marketing surveillance to monitor and reduce unregistered, sub-standard and falsified medicines in the market
  4. Strengthen Inspection and Licensing of pharmaceutical premises and Import/Export Controls
  5. Establish Laboratory Services
  6. Establish the Legal and Law Enforcement Function
  7. Establish and implement a Quality Management System
  8. Leverage ICT Services to enable efficiency

BoMRA will facilitate the review of the Medicines and Related Substance Act to strengthen its scope, definitions, structures, and instruments to enable its regulatory effectiveness.

Reduced incidences of substandard and falsified medicines and related substances.

The Botswana Medicines Regulatory Authority will establish a Pharmacovigilance system to track and report on Adverse Drug Reactions and take any remedial action to protect human and animal health.

Improved awareness and Public Trust in the Improved awareness and Public Trust in the Medical Products and Cosmetics regulatory system.

The Authority will:

  1. Educate the public on effective, safe and quality human and animal medicines and their regulation
  2. Facilitate stakeholder compliance
  3. Establish strategic partnerships and collaborations
  4. Establishing a robust Institutional Framework and Good Governance

BoMRA will scale up its current institutional capacity to deliver the full spectrum of regulatory services. In order to do this, the Authority will:

  1. Enhance its HR Management System
  2. Attract build and retain critical competencies to deliver on the regulatory requirements
  3. Instil a High-Performance Culture underpinned by its core values, an enabling environment and workplace, with an accountable workforce and leaders who are effective
  4. Improve sustainability to eventually become less reliant on government for its operations
  5. Implement prudency in its Financial Management
  6. Maintain institutional resources so they remain effective