CREATING A NEW MEDICINE REGISTRATION APPLICATION
NEW MEDICINE REGISTRATION APPLICATION PROCESS
1.1. Creating a new medicine registration application
1.1.1. Submissions
All new medicine applications need to be of a high standard in order to be evaluated by SAHPRA. New registration applications need to comply with current guidelines and submitted on the Engagement Portal. Applicants are expected to ensure that all required documents are included in the relevant sections.
1.1.2. Reliance models
SAHPRA will be implementing reliance models for qualifying applications. The General Information Guideline [2.01] contains the latest information regarding SAHPRA’s evaluation
pathways as well as SAHPRA’s Recognised Regulatory Authorities (RRAs) and collaborative /
work sharing procedures. The General Information Guideline is the primary reference for information on reliance, with additional information contained in the Clinical Guideline [2.09] and Quality and Bioequivalence Guideline [2.02].
1.1.3. GMP
All manufacturing and quality control sites affecting applications are required to be GMP compliant prior to the submission of the relevant application. A GMP certificate or equivalent manufacturing licence is required as evidence of GMP compliance. Please refer to 3.2 of the SA Guide to GMP [4.01] for additional information.
1.1.4. SCoRE document
The Summary of Critical Regulatory Elements (SCoRE) document is designed to enable a top- down summary-driven approach to reviews, reducing evaluation time of all applications. All new registration applications will require a completed SCoRE document [6.31] in 3.2.R.8.
1.1.5. Biostudy and biowaiver review forms
If a biostudy has been included in the application, please review and complete the Bioequivalence Trial Information Form (BTIF) Form. For circumstances where a biowaiver is submitted (no biostudy or biostudy done on a different product strength), please review and complete the following:
- IPRP template (for a BCS-based biowaiver)
- WHO template (for an additional strength biowaiver)
For the biowaiver templates, as well as additional information, please refer to the Quality and Bioequivalence Guideline. The location of where these documents should be placed in the dossier is indicated in the validation templates:
- ECTD Validation And Technical Screening For Renewals
- Validation Template For ECTD Variation Applications
1.1.6. Format change to PI and PIL
SAHPRA has adopted the EMA format for Professional Information and Patient Information Leaflets. This format is reflected in the updated SAHPRA guidelines:
1.1.7. Repository of PIs and PILs
SAHPRA has published a repository of PIs and PILs on its website for the benefit of health care providers and patients, as well as to enable streamlined Clinical evaluations of applications for generic medicines. Where available for a given molecule, applications for generic medicines are required to reference the latest published SAHPRA-approved innovator PI in the application. Clinical screening queries will be immediately flagged for applications referencing an outdated / illegible PI where the latest version has been published on SAHPRA’s website. Note that the published PIs on SAHPRA’s website may also be applicable to selected variation applications (e.g., safety update of a generic medicine where the same change has already been approved for the reference local innovator medicine).
Submitting an Application
Applications should be submitted on SAHPRAs Engagement Portal. After logging in to the SAHPRA portal, you will be directed to the Applications Dashboard where you can then create a new application.
Once completing the application process, notifications and updates on the sequence, submission and application will be available on the portal and via email.
For a detailed step-by-step guide, click on the button below:
Relevant Documents
