South Africa Adopts EU Marketing Authorization Guidelines to Ensure Timely Approval

In November 2019 the South African Health Products Regulatory Authority (SAHPRA) adopted the European Union’s (EU) guidelines to improve new product registrations and variation approvals. In the three years since the changes were introduced timelines have been dramatically reduced and companies are no longer having to wait years for their marketing authorizations to be approved.

Before the adoption of the EU guidelines applicants had to wait for approval from SAHPRA before making any changes, regardless of the variation type. This approach led to unnecessary and costly delays. Under the new process, Type 1 variations (such as administrative changes) do not require feedback before implementation as these alterations have no impact on the quality, efficacy, and safety of a product. Type 1B variations are those which have a minimum to moderate effect on the product quality (such as a shelf-life extension) and for these companies must wait 30 days following the health authority’s receipt of submission after which, even if no response has been received in the allotted time, the changes can still be implemented by the company. The revised process is now simpler and faster, reducing delays for applicants. This does not include Type 2 variations (such as major changes in approved manufacturing processes) which could impact a product’s safety, where applicants still must wait for feedback before implementing any changes.

For product registrations, prior to adopting the new guidelines, SAHPRA used one review system which was coupled with a heavy backlog and an eight-year wait for some applicants seeking approval. There are now four potential evaluation pathways in South Africa, and it is the responsibility of the applicant company to select which is most appropriate.

1. Full review
2. Abridged review – replacing the need to evaluate the entire data submitted alongside the application.

• Verified review – a review that verifies the application against information that has already been approved by the SAHPRA or a Recognised Regulatory Authority.

1. Recognition – a registration/approval process based on recognising the outcome of a review by a Recognised Regulatory Authority.

To tackle the backlog that had accumulated from previous years, a brief opportunity opened for applications submitted before 2018 that were still awaiting approvals. Applicants had the option to resubmit using the new variation guidelines and evaluation pathways to obtain a quicker response. This opportunity, which opened in August 2019 and later closed in 2020, included further costs for the applicant. However, under the revised system approval was granted by SAHPRA within a year of resubmitting. This enabled more medicines to be available to patients in South Africa.

How can ProductLife Group (PLG) support you with your applications to SAHPRA?

PLG offers expert advice to enhance the understanding and implementation of these revised guidelines and processes. Our team can help you to find the optimal approach, offering advice on the Marketing Authorisation Application, what can be submitted, the type of dossier to use, the potential timelines to expect, acceptability of variations, as well as insights into the next steps. Contact us to find out more about how PLG can help you navigate the SAHPRA, or about the wider services on offer.