Creating a New Medicine Registration Application
Everything you need to prepare a compliant SAHPRA filing in two minutes.
All applications must meet high standards and adhere to current guidelines, submitted in eCTD or eSubmission format.
Request application numbers prior to submission and consolidate multiple strengths into one dossier.
All submissions must be electronic and follow CTD specifications.
SAHPRA implements reliance models for qualifying applications, detailed in guidelines.
Manufacturing and quality control sites must comply with GMP before submission.
Include a Summary of Critical Regulatory Elements document for all new registration applications.
Complete necessary forms for biostudy or biowaiver submissions as per guidelines.
SAHPRA adopts the EMA format for Professional Information and Patient Information Leaflets.
Utilize SAHPRA's published repository of PIs and PILs, referencing them in generic medicine applications.
Submitting an Application
Deliver applications on CD, DVD, or USB to the provided address.
Screening
Applications undergo screening to ensure compliance with SAHPRA's requirements.
Evaluation
After screening, applications are evaluated by relevant SAHPRA units and undergo peer review.
Responses to Queries
Limited rounds of queries are allowed during screening and evaluation, with specified response times.
Certification
Upon recommendation for registration, applicants receive notification to collect new registration certificates.
Planning a SAHPRA Registration?
Pharmgenity supports API and formulation exporters with regulatory-ready dossiers and compliance guidance.
We Have Answers
These FAQs help exporters understand the practical compliance points that matter before submitting to SAHPRA.
Exporters should understand SAHPRA registration requirements, product documentation expectations, compliance timelines, and submission accuracy before entering the South African pharmaceutical market.
Commonly reviewed materials can include application dossiers, product data, labeling details, quality records, and other regulatory documents depending on the product and submission pathway.
Submission accuracy is important because incomplete or inconsistent filings can lead to avoidable questions, longer review cycles, and delays in market access.
Exporters can reduce delays by preparing complete documentation, following submission requirements carefully, responding quickly to queries, and planning local regulatory coordination in advance.
Yes. Local regulatory support can help exporters understand submission expectations, communication requirements, and approval-stage coordination more effectively.
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