Update on Current Operations at SAHPRA’s Interim Premises

Posted 05 February 2019

To all SAHPRA Stakeholders

Further to our communication of 25 January 2019, this notice serves to provide clarity on current operations at SAHPRA’s interim premises (CSIR), following the recent emergency relocation. As with any physical relocation, it is taking time for SAHPRA’s infrastructure, systems and processes (including internet and remote access to the National Department of Health network) to be re-established. The cellphone contact numbers under Key Contacts on the website should be used. More details with regard to contact information and new landline phone numbers will be communicated shortly.

Whilst Reception in Building 38a will open on Friday 1 February 2019, all stakeholders are advised to please adhere to the following guidelines.

Medicines registrations and variations

As previously advised, SAHPRA is embarking on an ambitious change program to clear its inherited backlog of medicines registration and variation applications. This program involves designing and implementing new policies and models for evaluation.

Three examples include:

  • For applications that have been registered by a SAHPRA approved regulatory authority or review process, applicants will be required to submit the same dossier as reviewed elsewhere together with the approval documents from the respective authorities
  • A digitally empowered approach to evaluation – no paper applications will be evaluated
  • Adoption of EMA variation classification

These new models will be adapted to “business as usual” i.e. applications received under SAHPRA since February 1st 2018, to vastly improve SAHPRA’s absorption capacity going forward.

Whilst the “business as usual” strategy will be finalised over the coming weeks, and published for comment, applicants are advised not to submit any non-critical dossiers / variation amendments until otherwise informed. Any new submissions submitted in February 2019 will be placed in the queue after previously received applications from February 2018 and will incur a risk of resubmission according to revised regulations and guidelines in the future.

Clinical trials

Submissions for clinical trials approvals should continue as normal.

Clinical trial notifications (e.g. progress reports, study reports, brochures), CDs with cover letters only should be submitted.

Section 21 authorisations

Submissions for Section 21 authorisations should continue as normal using the digital procedure highlighted in communication 9.113.

Medical devices

All submissions should be properly bookmarked searchable PDF with functional hyperlinks on appropriately labelled CDs accompanied by a cover letter.

Complementary medicines

All submissions should be properly bookmarked searchable PDF with functional hyperlinks on appropriately labelled CDs accompanied by a cover letter.

Additional copies will be required after successful screening outcome.

Complementary section 21 applications should be submitted via email [email protected].

Permits and Licences

SAHPRA acknowledges its limited ability in recent months to issue permits and licences due to the protest action about the Civitas building. Delays have impacted medicines availability and the pharmaceutical industry.

Additional capacity has been allocated to clear all pending permits and licences.

Similar to medicines registrations and variations, however, there is significant work underway to re-engineer the permits and licences process.

This will enable a faster and more effective process. Pilots will commence over the coming weeks and applicants are kindly advised not to submit any non-critical applications until otherwise informed.

Cannabis

SAHPRA is not yet receiving applications for cannabis cultivation. There will be an update in the coming weeks on policies and procedures for cannabis cultivation and related matters.

As ever, given the variety and size of the immediate challenges facing SAHPRA, a pragmatic approach to move forward requires collaboration and patience from all stakeholders in South Africa’s health system. We will commit to regular updates to ensure that, together, we can build an effective, efficient and sustainable health products regulator in South Africa.

Ms P Nkambule

Acting Chief Executive Officer

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