1. Technical specifications - ICH guidelines downloadable from http://estri.ich.org/e2br22/index.htm
2. The preferred encoding is ISO-8859-1 but UTF8 is also acceptable
3. Each xml file can contain up to 100 ICSRs.
4. Organisation identifier – SAHPRA
Important information to note:
• Testing of cases is no longer required.
• Reports can be uploaded in either E2B R2 or E2B R3 formats.
Applicants joining the e2b reporting portal are advised to refrain from sending ADR reports in both paper and e2b
formats simultaneously, as this results in duplication of reports on the system. That is, once an applicant has
started sending reports in e2b format, they must immediately stop sending ADRs in paper formats. Applicants
are not required to inform the Authority before they begin with e2b submissions. A response message will be
forwarded to the email address used together with acknowledgement letter/s, therefore “no reply” email
addresses should not be used.
All ADR reports in e2b format must be sent to e2b@sahpra.org.za
Contact Details
South African Health Products Regulatory Authority
Vigilance unit
Tel: (012) 842 7609/10
Email: e2b@sahpra.org.za
1. Technical specifications - ICH guidelines downloadable from http://estri.ich.org/e2br22/index.htm
2. The preferred encoding is ISO-8859-1 but UTF8 is also acceptable
3. Each xml file can contain up to 100 ICSRs.
4. Organisation identifier – SAHPRA
Important information to note:
• Testing of cases is no longer required.
• Reports can be uploaded in either E2B R2 or E2B R3 formats.
Applicants joining the e2b reporting portal are advised to refrain from sending ADR reports in both paper and e2b
formats simultaneously, as this results in duplication of reports on the system. That is, once an applicant has
started sending reports in e2b format, they must immediately stop sending ADRs in paper formats. Applicants
are not required to inform the Authority before they begin with e2b submissions. A response message will be
forwarded to the email address used together with acknowledgement letter/s, therefore “no reply” email
addresses should not be used.
All ADR reports in e2b format must be sent to e2b@sahpra.org.za
Contact Details
South African Health Products Regulatory Authority
Vigilance unit
Tel: (012) 842 7609/10
Email: e2b@sahpra.org.za
