eCTD Filing Types for ZA
Calyx RIM provides the following filing types for all application types associated with South Africa (ZA). This table lists the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| Applicant transfer, name and address change of applicant (post-reg-hcr) | za-1-0 | post-reg-hcr | CTA, NDA |
| Biological committee response (pre-reg-biol) | za-1-0 | pre-reg-biol | CTA, NDA |
| Biologicals and biosimilars (post-reg-biol) | za-1-0 | post-reg-biol | CTA, NDA |
| Biosimilar (na-bs) | za-1-0 | na-bs | CTA, NDA |
| Call-up (na-cu) | za-1-0 | na-cu | CTA, NDA |
| Cancellation of a registered product (cancellation) | za-1-0 | cancellation | CTA, NDA |
| Clinical (post-reg-cl) | za-1-0 | post-reg-cl | CTA, NDA |
| Clinical (pre-reg-cl) | za-1-0 | pre-reg-cl | CTA, NDA |
| Complementary Medicines (na-cm) | za-1-0 | na-cams | CTA, NDA |
| Complementary Medicines (post-reg-cm) | za-1-0 | post-reg-cams | CTA, NDA |
| Complementary Medicines (pre-reg-cm) | za-1-0 | pre-reg-cams | CTA, NDA |
| Inspectorate (post-reg-insp) | za-1-0 | post-reg-insp | CTA, NDA |
| Inspectorate (pre-reg-insp) | za-1-0 | pre-reg-insp | CTA, NDA |
| Line extension (na-le) | za-1-0 | na-le | CTA, NDA |
| Multisource (na-ms) | za-1-0 | na-ms | CTA, NDA |
| New Chemical Entity – Biological (na-nce-b) | za-1-0 | na-nce-b | CTA, NDA |
| New Chemical Entity – Pharmaceutical (na-nce-ph) | za-1-0 | na-nce-ph | CTA, NDA |
| Pharmaceutical and Analytical (post-reg-pa) | za-1-0 | post-reg-pa | CTA, NDA |
| Pharmaceutical and Analytical (pre-reg-pa) | za-1-0 | pre-reg-pa | CTA, NDA |
| Pharmaceutical and Analytical and Inspectorate (post-reg-pa-insp) | za-1-0 | post-reg-pa-insp | CTA, NDA |
| Pharmaceutical & Analytical and Inspectorate (pre-reg-pa-insp) | za-1-0 | pre-reg-pa-insp | CTA, NDA |
| Proprietary name (pre-reg-pn) | za-1-0 | pre-reg-pn | CTA, NDA |
| Proprietary name change application (post-reg-pn) | za-1-0 | post-reg-pn | CTA, NDA |
| Response to Council resolutions (pre-reg-cr) | za-1-0 | pre-reg-cr | CTA, NDA |
| Scheduling (pre-reg-sch) | za-1-0 | pre-reg-sch | CTA, NDA |
| Updates following a proprietary name change approval (post-reg-pn-update) | za-1-0 | post-reg-pn-update | CTA, NDA |
| Withdrawal of a submission* (withdrawal) | za-1-0 | withdrawal | CTA, NDA |
| Applicant transfer, name and address change of applicant (post-reg-hcr) | za-2-1 | post-reg-hcr | CTA, NDA |
| Biological committee response (pre-reg-biol) | za-2-1 | pre-reg-biol | CTA, NDA |
| Biologicals and biosimilars (post-reg-biol) | za-2-1 | post-reg-biol | CTA, NDA |
| Biosimilar (na-bs) | za-2-1 | na-bs | CTA, NDA |
| Call-up (na-cu) | za-2-1 | na-cu | CTA, NDA |
| Cancellation of a registered product (cancellation) | za-2-1 | cancellation | CTA, NDA |
| Clinical (post-reg-cl) | za-2-1 | post-reg-cl | CTA, NDA |
| Clinical (pre-reg-cl) | za-2-1 | pre-reg-cl | CTA, NDA |
| Complementary Medicines (na-cm) | za-2-1 | na-cm | CTA, NDA |
| Complementary Medicines (post-reg-cm) | za-2-1 | post-reg-cm | CTA, NDA |
| Complementary Medicines (pre-reg-cm) | za-2-1 | pre-reg-cm | CTA, NDA |
| Inspectorate (post-reg-insp) | za-2-1 | post-reg-insp | CTA, NDA |
| Inspectorate (pre-reg-insp) | za-2-1 | pre-reg-insp | CTA, NDA |
| Line extension (na-le) | za-2-1 | na-le | CTA, NDA |
| Multisource (na-ms) | za-2-1 | na-ms | CTA, NDA |
| New Chemical Entity – Biological (na-nce-b) | za-2-1 | na-nce-b | CTA, NDA |
| New Chemical Entity – Pharmaceutical (na-nce-ph) | za-2-1 | na-nce-ph | CTA, NDA |
| Pharmaceutical and Analytical (post-reg-pa) | za-2-1 | post-reg-pa | CTA, NDA |
| Pharmaceutical and Analytical (pre-reg-pa) | za-2-1 | pre-reg-pa | CTA, NDA |
| Proprietary name (pre-reg-pn) | za-2-1 | pre-reg-pn | CTA, NDA |
| Proprietary name change application (post-reg-pn) | za-2-1 | post-reg-pn | CTA, NDA |
| Reformat Filing | za-2-1 | baseline | CTA, NDA |
| Response to Council resolutions (pre-reg-cr) | za-2-1 | pre-reg-cr | CTA, NDA |
| Scheduling (pre-reg-sch) | za-2-1 | pre-reg-sch | CTA, NDA |
| Updates following a proprietary name change approval (post-reg-pn-update) | za-2-1 | post-reg-pn-update | CTA, NDA |
| Withdrawal Filing | za-2-1 | withdrawal | CTA, NDA |
| Inspectorate (resp-post-reg-insp) | za-2-1 | resp-post-reg-insp | CTA, NDA |
| Pharmaceutical and Analytical (resp-post-reg-pa) | za-2-1 | resp-post-reg-pa | CTA, NDA |
| Clinical (resp-post-reg-cl) | za-2-1 | resp-post-reg-cl | CTA, NDA |
| Proprietary name change application (resp-post-reg-pn) | za-2-1 | resp-post-reg-pn | CTA, NDA |
| Updates following a proprietary name change approval (resp-post-reg-pn-update) | za-2-1 | resp-post-reg-pn-update | CTA, NDA |
| Applicant transfer, name and address change of applicant (resp-post-reg-hcr) | za-2-1 | resp-post-reg-hcr | CTA, NDA |
| Biologicals and biosimilars (resp-post-reg-biol) | za-2-1 | resp-post-reg-biol | CTA, NDA |
| Complementary Medicines (resp-post-reg-cm) | za-2-1 | resp-post-reg-cm | CTA, NDA |
1 *If there is no such filing type in the database, South Africa will be associated with the existing Withdrawal Filing filing type.