Publications
- Acts, Regulations and Govt notices [31]
- Application Forms [35]
- Clinical Trials [25]
- Communications [101]
- Exemptions [1]
- Fees [4]
- Frequently Asked Questions (FAQs) [1]
- Guidelines [123]
- Industry to comment [34]
- Licences [3]
- News and Information [3]
- Policies [1]
- Product Recalls [14]
- Professional Information and Patient Information Leaflets [293]
- Registration Notifications [91]
- Safety Communications [34]
- Workshops and Conferences [57]
Guidelines
Complementary [ 8 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
 | 7.05 | Naming and labelling conventions for active ingredients in complementary medicines | V1 | 1.1 | 23-Sep-2019 | 186 KB | |
| 1 | Roadmap and Transitional Process for the Regulation of Complementary Medicines | V1 | 1.1 | 23-Sep-2019 | 266 KB | |
| 7.05 | Complementary Medicines Registration Application ZA-CTD - Quality | V1 | 13-Jun-2016 | 1 MB | ||
| 7.03 | Complementary Medicines - Use of the ZA-CTD format in the Preparation of a Registration Application | V3 | 13-Jun-2016 | 355 KB | ||
| 7.01 | Complementary Medicines - Discipline Specific Safety and Efficacy | V3 | 13-Jun-2016 | 1 MB |
eCTD [ 18 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 2.28 | Questions & Answers - Implementation of eCTD in South Africa | V4 | 30-May-2019 | 361 KB | ||
| 2.21 | SA Specification for eCTD Regional - Module 1 showing changes | V3 | 30-May-2019 | 523 KB | ||
| 2.21 | SA Specification for eCTD Regional - Module 1 | V3 | 30-May-2019 | 519 KB | ||
| 2.22 | South African eCTD Validation Criteria | V2 | 2.1 | 11-Apr-2017 | 281 KB | |
| 2.23 | Guidance for submission of regulatory information in eCTD format | V2 | 2.1 | 11-Apr-2017 | 530 KB |
General [ 33 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 2.40 | Multiple submissions of the same application with different proprietary names | V4 | 30-May-2019 | 340 KB | ||
| 1.01 | Guidelines & Forms Table of Contents | V10 | 30-May-2019 | 105 KB | ||
| 2.24 | Guidance for the submission of the South African CTD/eCTD - General & Module 1 | V6 | 30-May-2019 | 303 KB | ||
| 2.38 | International metric system | V3 | 29-Mar-2019 | 27 KB | ||
| 2.44 | Cultivation of Cannabis & Manufacture of Cannabis-related Pharmaceutical Products for medicinal and research purposes | V2 | 06-Nov-2017 | 299 KB |
Good Manufacturing Practices [ 13 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 411 | How to Resond to a GMP, GWP or GCP Inspection Report | V1 | 1.1 | 27-Nov-2019 | 122 KB | |
| 4.01 | SA Guide to Good Manufacturing Practice for Medicines | V6 | 29-Dec-2017 | 128 KB | ||
| 4.02 | South African Good Wholesaling Practice for Wholesalers | V2 | 25-Jul-2016 | 743 KB | ||
| 4.10 | Wholesalers to Export Medicinal Products | V1 | 17-May-2016 | 210 KB | ||
| 4.07 | Radiopharmaceutical manufacture | V1 | 30-Jun-2015 | 150 KB |
Human [ 29 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 1 | Guidelines: How to Submit Expressions of Interest to SAHPRA on SADC Medicines Regulatory Work-Sharing, Zazibona Collaborative Process | V1 | 1.1 | 31-Oct-2019 | 421 KB | |
| 1 | SAHPRA Expression of Interest on WHO Collaborative Registration Procedure | V1 | 1.1 | 31-Oct-2019 | 214 KB | |
| 1 | Guideline- Active Pharmaceutical Ingredient Master File | V1 | 1.1 | 31-Oct-2019 | 497 KB | |
| 1 | ANNOUNCEMENT ON REQUIREMENTS FOR NON-RESUBMISSION OF NEW REGISTRATION BACKLOG APPLICATIONS | V1 | 1.1 | 03-Oct-2019 | 226 KB | |
| 1 | Sartan-containing medicine registration | V1 | 1.1 | 06-Aug-2019 | 154 KB |
Medical Devices and In Vitro Diagnostics [ 7 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 8.10 | Questions & Answers: Licensing of Medical Device Establishments | V1 | 29-Dec-2017 | 97 KB | ||
| 8.05 | Classification of Medical Devices and IVDs | V2 | 01-Aug-2017 | 794 KB | ||
| 8.07 | Medical Device Quality Manual | V2 | 01-Aug-2017 | 440 KB | ||
| 8.04 | Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDs | V2 | 01-Aug-2017 | 754 KB | ||
| 16.03 | Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs | V1 | 1.1 | 20-Sep-2016 | 463 KB |
Veterinary [ 13 ]
Type | Doc# | Version | SubVersion | PublishDate | Select | ||
|---|---|---|---|---|---|---|---|
| 3.01 | General Veterinary information | V1 | 22-Jun-2015 | 492 KB | ||
| 3.03 | Bioavailability and Bioequivalence of Veterinary Medicines | V1 | 13-Jan-2014 | 422 KB | ||
| 3.13 | Veterinary Antimastitis Products | V1 | 04-Nov-2013 | 343 KB | ||
| 3.12 | Veterinary orphan products | V1 | 14-May-2012 | 149 KB | ||
| 3.12 | Veterinary Orphan Products | V1 | 07-May-2012 | 149 KB |