Important documents communicated in the past week

April 29, 2020

SAHPRA Communication on GCP Training | Submission of Covid-19 Clinical Trial Applications  | Payment of Retention Fees for Registered Medicines and Wholesale Licenses. 

 

 

GCP Training and Expedited review of Clinical Trial applications during Covid-19 pandemic:

 

SAHPRA recognise that the COVID-19 pandemic impacts on social distancing and approach to the conduct of clinical trials. The Authority took note of the high transmission of COVID-19 and some of the affected being the healthcare professionals. In line with the recommendations for social distancing and in order to combat the spread of COVID-19, SAHPRA has amended the requirements for face to face GCP training to allow comprehensive on-line Good Clinical Practice (GCP) training during the COVID-19 pandemic. 

 

SAHPRA has recently received queries regarding the procedure for submission of COVID-19 Clinical Trials Applications.

The Authority is committed to expedite review of COVID-19 related clinical trial applications with the review timeline between 7-10 working days.

The applications should be emailed to ctcresponses@sahpra.org.za and copy the following email addresses:

 

kedibone.malatji@sahpra.org.za and dominicah.thosago@sahpra.org.za

 

Download the SAHPRA communication here:

 

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Payment of retention fees for the Financial year ending 31 March 2020 in respect of Medicines registered up and until 31 December 2019 and/or manufacture or Wholesale Licences 

 

Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. These retention fees are payable by no later than 30 June 2020, failing which the registration or licence may be cancelled.

Download the SAHPRA document here.

 

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SAHPRA Reliance Template Q & A:

 

The reliance template is required to ensure the products are fundamentally the same, and evaluate minor or non-technical differences; however, SAHPRA will complete part of the review template –it will no longer be the applicant’s responsibility alone. The reliance template will be populated by both applicant and SAHPRA. SAHPRA will populate the RRA section of the reliance template while applicant will provide information from the application submitted to SAHPRA

Reliance Q &A: Download here:

 

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Business for South Africa: Health Working Group forum Newsletter 4 on engaging with the DTI and ITAC on export permits.

Download here:

 

Business for South Africa on Cloth Masks and contributing to South Africa's Medical personnel's PPE

Download here:

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