South African market for Pharmaceuticals is evolving swiftly, due credit given to the South African Health Products Regulatory Authority’s (SAHPRA’s) aim to accelerate drug registration process. A medicinal product needs approval from the SAHPRA for distribution or marketing for Human or Veterinary use in South Africa. Apart from the agency’s unique Regulatory requirements for the submissions of initial, post-approval and life cycle management information, the country’s dynamic Regulatory landscape might make it challenging for new market entrants to explore the market.

Freyr caters Regulatory support with a dedicated Regulatory team for South Africa that include guidance during product development, gap analysis of executed data, remediation plan based on the South African submission requirements for initial marketing authorizations, post-approval changes and life cycle management (LCM) for pharmaceutical and biological products.


Freyr Expertise

  • Regulatory submission road map for medicinal products registration in South Africa
  • Pre-submission administrative activities, pre-submission interaction with health authority (HA) for any clarification required
  • Evaluation of the product source data from R&D and manufacturing site (executed data) for the South Africa specific Regulatory requirements
  • Compilation and submission of the dossiers to HA in ZA CTD/eCTD format
  • Regulatory consultation during the development of the medicinal products
  • Holder of Certificate of Registration (HCR), Responsible Pharmacist (RP), and Qualified Person for Pharmacovigilance (QPPV) in South Africa
  • Post approval change submissions with strategy and compilation for - 
    • Marketing Authorization Holder (MAH) transfers
    • Post - approval quality amendments like batch size change, changes in manufacturing process and manufacturing sites, administrative and labeling changes
    • Pharmacopoeia monograph updates
    • Changes in approved container closure system
    • Change in approved primary packaging material supplier
    • Amendments in shelf life extension or reduction
    • Addition of new supplier change or deletion of registered Active material supplier
  • ZA CTD conversion of legacy products from old MBR1/MRF1 format
  • Designing of specifications for Active Pharmaceutical Ingredient (API), finished product & intermediates
  • Consulting on limits for impurities including genotoxic & elemental
  • Designing of protocols (Stability, Analytical Method Validation, Exhibit Batch, Process Validation)
  • Change control evaluation and compliance activities
  • Support in handling response to HA queries