Brief

On 20/09/2024, the South African Health Products Regulatory Authority (SAHPRA) issued an update regarding "Feedback on SAHPRA’s EOIs and latest appointments". Since 2023, SAHPRA has published four Expression of Interests (EOIs), all of which have been closed. Three out of the four EOIs were finalized with appointments made, while two external evaluator vacancies for the Medical Devices and IVDs Committee and Veterinary Committee remain open and in progress.

20 Sep Feedback on SAHPRA’s EOIs and latest appointments

Posted at 08:57h
in News & Updates
by Melanie Govindasamy

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The South African Health Products Regulatory Authority (SAHPRA) has published four (4) Expression of Interests (EOIs) since 2023, and these have all been closed.

Updates on EOIs:

Ref: SAHPRA69092024 – Pharmaceutical Evaluations Management EOI closed on Friday, 26 April 2024. Appointments were made.
Ref: SAHPRA20862023 – The EOI was closed on Friday, 15 December 2023. GxP was finalised and appointments made. The remaining are still open and in progress (two (2) external evaluators for the Medical Devices and IVDs Committee (Veterinary expert and Clinical Trials for Medical Devices and IVDs) and two (2) external evaluators for the Veterinary Committee.
Ref: SAHPRA72652024 Clinical and Clinical Trials Committee members EOI closed on Monday, 10 June 2024. Committee members posts were finalised, and appointments made. Only External Evaluators’ vacancies still remain open and in progress.
Ref: SAHPRA73902024 BMC EOI was issued and closed on Friday, 14 June 2024. This is still in progress.

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Purpose
The South African Health Products Regulatory Authority (SAHPRA) has published updates regarding their Expression of Interests (EOIs), including closure dates, appointment statuses, and remaining vacancies. This information is crucial for stakeholders, particularly those in the pharmaceutical, medical devices, and veterinary industries.

Effects on Industry

The closure of SAHPRA’s EOIs and the subsequent appointments have significant implications for the industry. Companies involved in the evaluation and approval processes must adapt to the changes brought about by these updates. The remaining open positions may indicate a need for industry players to reassess their workforce capabilities or consider partnering with external evaluators to fill the gaps.

The updates also reflect SAHPRA’s efforts to strengthen its regulatory framework, which will ultimately impact the pharmaceutical, medical devices, and veterinary industries in South Africa. Companies operating within these sectors must ensure compliance with new regulations and guidelines, potentially leading to changes in business operations or investment strategies.

Relevant Stakeholders
The stakeholders most affected by this update include:

  • Pharmaceutical companies seeking regulatory approval for their products
  • Medical device manufacturers requiring evaluation and clearance from SAHPRA
  • Veterinary product suppliers relying on the authority’s regulations for their industry
  • External evaluators interested in partnering with SAHPRA to fill vacant positions

These stakeholders will need to closely monitor SAHPRA’s updates, adjust their business strategies as necessary, and ensure compliance with new regulations to avoid any potential consequences.

Next Steps

To comply with or respond to this update, companies within the affected industries must:

  • Review SAHPRA’s latest EOIs and understand the implications for their operations
  • Ensure they have the necessary resources or expertise to meet the updated regulatory requirements
  • Consider partnering with external evaluators if they need additional support
  • Stay informed about future updates from SAHPRA to adapt to any changes in the regulatory landscape

By taking these steps, companies can minimize disruptions and capitalize on opportunities presented by the evolving regulatory environment.

Any Other Relevant Information
Historically, SAHPRA has been proactive in updating its regulations to ensure they align with international standards and best practices. This commitment to quality and safety is reflected in their efforts to strengthen their regulatory framework through the closure of EOIs and appointment of industry experts.

The updates also highlight SAHPRA’s willingness to collaborate with external evaluators, fostering a spirit of cooperation within the industry. Companies can leverage this opportunity to build partnerships and improve their chances of success in the competitive market.

Overall, these developments underscore the importance of adaptability and strategic planning in the face of changing regulatory landscapes. By staying informed and responsive, companies within the pharmaceutical, medical devices, and veterinary industries can navigate these shifts effectively and maintain a strong market presence.

South African Health Products Regulatory Authority (SAHPRA)

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