Creating a New Medicine Registration Application:

1. Submission Standards: All applications must meet high standards and adhere to current guidelines, submitted in eCTD or eSubmission format.
2. Application Number: Request application numbers prior to submission and consolidate multiple strengths into one dossier.
3. Electronic Submissions: All submissions must be electronic and follow CTD specifications.
4. Reliance Models: SAHPRA implements reliance models for qualifying applications, detailed in guidelines.
5. GMP Compliance: Manufacturing and quality control sites must comply with GMP before submission.
6. SCoRE Document: Include a Summary of Critical Regulatory Elements document for all new registration applications.
7. Biostudy and Biowaiver Review: Complete necessary forms for biostudy or biowaiver submissions as per guidelines.
8. PI and PIL Format Change: SAHPRA adopts the EMA format for Professional Information and Patient Information Leaflets.
9. Repository of PIs and PILs: 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.