Data Administration Updates: Ennov InSight 7.2. 11
Running the migration script updates Data Administration with latest changes. The changes must be reviewed, and updated, as necessary.
ZA v3.1 Updates
If ZA region already exists in the section in Data Administration, it will be updated to have the ZA code value in the database. If ZA region does not exist, an error message will be generated, and the script will skip South Africa updates.
The Health Authority name for South Africa country must be changed to the following:
| Country Name | Health Authority Name | Health Authority Abbreviation | Health Authority eCTD Code | Health Authority website |
|---|---|---|---|---|
| South Africa | South African Health Products Regulatory Authority | SAHPRA | ZA-SAHPRA | https://ectd.sahpra.org.za/index.html |
The South Africa country will receive ZA as eCTD code.
If the ZA-3-1 Assembly DTD/Schema type already exists in the list in Data Administration, it will be activated (if inactive) and updated to have the ZA-3-1 code value. Otherwise, the ZA-3-1 Assembly DTD/Schema will be added.
If the National ZA Procedure Type already exists in the list in Data Administration, it will be activated (if inactive) and updated to have the National eCTD code value. Otherwise, the National ZA Procedure Type will be added.
Application Type Values
The
Application Type Values list will be added to the
section if it does not already exist. The list includes the following values:
| Application Type | Name | Display Name | Entity XML Type Name | Application Category | Countries |
|---|---|---|---|---|---|
| ZA-NP | SAHPRA National Procedure | SAHPRA National Procedure | New Drug Application | SAHPRA National Procedure | South Africa |
| AMAP | AMA Procedure | AMA Procedure | New Drug Application | AMA Procedure | South Africa |
| JR | ZAZIBONA Joint Review | ZAZIBONA Joint Review | New Drug Application | ZAZIBONA Joint Review | South Africa |
| WHO-PQ | WHO-PQ | WHO-PQ | New Drug Application | WHO-PQ | South Africa |
| WHO-CRP | WHO SRA CRP | WHO SRA CRP | New Drug Application | WHO SRA CRP | South Africa |
| CH-GHP | Swissmedic MAGHP | Swissmedic MAGHP | New Drug Application | Swissmedic MAGHP | South Africa |
| EU-M4ALL | EU M4ALL | EU M4ALL | New Drug Application | EU M4ALL | South Africa |
Application Type eCTD Codes
The Application Type eCTD Codes values will be added to the list in Data Administration if they do not already exist there. If they exist, the eCTD Code for ZA-3-1 DTD/Schema will be added to them. The list of new values includes the following:
| Application Type (Display Name) | Application DTD/Schema | eCTD Code | Agency Abbreviation | Limit to Cross Application Only |
|---|---|---|---|---|
| SAHPRA National Procedure | ZA-3-1 | app-type-1 | No | |
| AMA Procedure | ZA-3-1 | app-type-2 | No | |
| ZAZIBONA Joint Review | ZA-3-1 | app-type-3 | No | |
| WHO-PQ | ZA-3-1 | app-type-4 | No | |
| WHO SRA CRP | ZA-3-1 | app-type-5 | No | |
| Swissmedic MAGHP | ZA-3-1 | app-type-6 | No | |
| EU M4ALL | ZA-3-1 | app-type-7 | No |
Filing Type eCTD Codes
The Filing Type eCTD Codes values will be added to the list in Data Administration if they do not already exist. If they exist, the eCTD Code for ZA-3-1 DTD/Schema is added to them. The list of new values includes the following:
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| A - NCE New Chemical Entity | ZA-3-1 | sub-type-1 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| D - New Generic Medicine | ZA-3-1 | sub-type-2 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
|
Complementary Medicine - New |
ZA-3-1 | sub-type-3 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| New Biological | ZA-3-1 | sub-type-4 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Biosimilar (na-bs) | ZA-3-1 | sub-type-5 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Clinical Trial Application | ZA-3-1 | sub-type-6 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| New Vaccines | ZA-3-1 | sub-type-7 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| I: Vaccine Antigen Master File | ZA-3-1 | sub-type-8 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| New SMF | ZA-3-1 | sub-type-9 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| New APIMF | ZA-3-1 | sub-type-10 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Plasma Master File (PMF) | ZA-3-1 | sub-type-11 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Line extension-New Strength | ZA-3-1 | sub-type-12 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Line extension-New Dosage Form | ZA-3-1 | sub-type-13 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Line extension-New Application | ZA-3-1 | sub-type-14 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Clone | ZA-3-1 | sub-type-15 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Replica-Same | ZA-3-1 | sub-type-16 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IA-Quality | ZA-3-1 | sub-type-17 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IAin-Clinical | ZA-3-1 | sub-type-18 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IAin-Quality | ZA-3-1 | sub-type-19 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IB-Clinical | ZA-3-1 | sub-type-20 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IB-Quality | ZA-3-1 | sub-type-21 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type I-Inspectorate | ZA-3-1 | sub-type-22 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type I-Other | ZA-3-1 | sub-type-23 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Safety (Clinical) | ZA-3-1 | sub-type-24 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II - Safety and Efficacy (Clinical) | ZA-3-1 | sub-type-25 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Quality | ZA-3-1 | sub-type-26 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Rescheduling | ZA-3-1 | sub-type-27 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Proprietary Name Change | ZA-3-1 | sub-type-28 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Change in Applicant- Relinquishing | ZA-3-1 | sub-type-29 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type II-Change in Applicant- Acquiring | ZA-3-1 | sub-type-30 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Baseline | ZA-3-1 | sub-type-31 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| z-Code-Quality | ZA-3-1 | sub-type-32 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Pharmacovigilance | ZA-3-1 | sub-type-33 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| USRN-Clinical and Pharmacovigilance | ZA-3-1 | sub-type-34 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Application Withdrawal/Cancellation | ZA-3-1 | sub-type-35 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, ND |
| Renewal Filing | ZA-3-1 | sub-type-36 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Undefined Regulatory Activity* | ZA-3-1 | sub-type-37 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type lB-Related Clinical | ZA-3-1 | sub-type-38 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type lB-Related Quality | ZA-3-1 | sub-type-39 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type lB-Related Inspectorate | ZA-3-1 | sub-type-40 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type IA-Clinical | ZA-3-1 | sub-type-41 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type ll-Related Clinical | ZA-3-1 | sub-type-42 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type ll-Related Quality | ZA-3-1 | sub-type-43 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
| Type ll-Related Inspectorate | ZA-3-1 | sub-type-44 | ZA-NP, AMAP, JR, WHO-PQ, WHO-CRP, CH-GHP, EU-M4ALL, CTA, NDA |
Sub Filing Type eCTD Codes
The Sub Filing Type eCTD Codes values will be added to the section in Data Administration if they do not already exist. If they exist, the eCTD Code for ZA-3-1 DTD/Schema is added to them. The list of new values includes the following:
| Sub Filing Type (Display Name) | Applicable DTD/Schema | eCTD Code | Available for Filing Type | |
|---|---|---|---|---|
| Initial | ZA-3-1 | seq-type-1 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Supplementary Information | ZA-3-1 | seq-type-2 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-Clinical | ZA-3-1 | seq-type-3 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-Quality | ZA-3-1 | seq-type-4 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-Inspectorate | ZA-3-1 | seq-type-5 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-N and S | ZA-3-1 | seq-type-6 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Closing Information | ZA-3-1 | seq-type-7 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Work Grouping Partial Withdrawal | ZA-3-1 | seq-type-8 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Submission Withdrawal | ZA-3-1 | seq-type-9 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-Biological | ZA-3-1 | seq-type-10 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-Renewals | ZA-3-1 | seq-type-11 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
| Response-PV | ZA-3-1 | seq-type-12 | A - NCE New Chemical Entity, D - New Generic Medicine, Complementary Medicine - New, New Biological, Biosimilar (na-bs), Clinical Trial Application, New Vaccines, I: Vaccine Antigen Master File, New SMF, New APIMF, Plasma Master File (PMF), Line extension-New Strength, Line extension-New Dosage Form, Line extension-New Application, Clone, Replica-Same, Type IA-Quality, Type IAin-Clinical, Type IAin-Quality, Type IB-Clinical, Type IB-Quality, Type I-Inspectorate, Type I-Other, Type II-Safety (Clinical), Type II - Safety and Efficacy (Clinical), Type II-Quality, Type II-Rescheduling, Type II-Proprietary Name Change, Type II-Change in Applicant-Relinquishing, Type II-Change in Applicant-Acquiring, Baseline, z-Code-Quality, Pharmacovigilance, USRN-Clinical and Pharmacovigilance, Application Withdrawal/Cancellation, Renewal Filing, Undefined Regulatory Activity*, Type lB-Related Clinical, Type lB-Related Quality, Type lB-Related Inspectorate, Type IA-Clinical, Type ll-Related Clinical, Type ll-Related Quality, Type ll-Related Inspectorate | |
Regulatory Activity Lead Values
The Regulatory Activity Lead Values will be added to the list in Data Administration if they do not already exist. The list of new values includes the following:| Region | Applicable DTD/Schema | eCTD Code | Regulatory Activity Lead |
|---|---|---|---|
| South Africa | ZA-3-1 | sub-lead-1 | Biologicals |
| South Africa | ZA-3-1 | sub-lead-2 | Complimentary |
| South Africa | ZA-3-1 | sub-lead-3 | Master Files |
| South Africa | ZA-3-1 | sub-lead-4 | Orthodox |
| South Africa | ZA-3-1 | sub-lead-5 | Pharmacovigilance |
| South Africa | ZA-3-1 | sub-lead-6 | Veterinary |
Evaluation Pathway Values
The Evaluation Pathway Values will be added to the list in Data Administration if they do not already exist. The list of new values includes the following:| Region | Applicable DTD/Schema | eCTD Code | Regulatory Activity Lead |
|---|---|---|---|
| South Africa | ZA-3-1 | eval-path-1 | Priority |
| South Africa | ZA-3-1 | eval-path-2 | Full Evaluation |
| South Africa | ZA-3-1 | eval-path-3 | Abridged Evaluation |
| South Africa | ZA-3-1 | eval-path-4 | Rolling Review |
| South Africa | ZA-3-1 | eval-path-5 | Section 21 |
Applicant Contact Type Values
The Applicant Contact Type Values will be added to the section in Data Administration if they do not already exist. The list of new values includes the following:| eCTD Standard Type | Region | Regulatory Code | Applicant Contact Type |
|---|---|---|---|
| eCTD 3.2 | South Africa | contact-type-1 | Local Applicant |
| eCTD 3.2 | South Africa | contact-type-2 | Regulatory |
| eCTD 3.2 | South Africa | contact-type-3 | Technical |
| eCTD 3.2 | South Africa | contact-type-4 | Product Information |
| eCTD 3.2 | South Africa | contact-type-5 | General |