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We need information on:
1) What are reportable cases to the countries mentioned below?
2) What are the timeline?
3) Which is the regulatory agency?
4) How to submit (address/phone/email/fax)?
5) What format CIOMS I/e2b xml/Medwatch or any other local form?
Thank you for your enquiry. Pharma companies usually have a team who is responsible for regulatory intelligence, and this team will search the internet for local Health Authorities (HA) and their PV requirements, or contact HA by mail to find out, particularly as these requirements may change over time. Many pharma companies also subscribe to a pay-for service which provides these regulatory requirements. Please note that in addition to submissions of ICSRs, multiple other PV requirements are likely apply, such as submission of PSUR and Risk Management Plans, Educational Material, or having a local person responsible for PV (QPPV/Local safety Responsible) in place to name but a few.
As an example to guide you further: Jordan
- Guidelines of Dec-2014 on Good Pharmacovigilance Practices for Arab Countries have been effective since 01 Jul 2015 in Jordan, in addition to several local laws
– report ICSR to Jordan Pharmacovigilance Center (JPC) / Rational Drug Use (RDU) Division by mail, phone, e-mails or online submission
Jordan Food and Drug Administration (JFDA):
Shafa Badran – Marj AlFaras
AlKayed Al Qtaishat Street
P.O Box/Zip Code: 11181/811951
Phone: +962 6 5632000
E-mails: firstname.lastname@example.org; email@example.com
- The reporting of any adverse drug reaction (whether mentioned in the PIL or not), with 4 minimum criteria
- report non-efficacy, exposure during pregnancy/lactation
- Report through the International CIOMS Form (for vaccines use: Jordanian Vaccine Adverse Event Reporting System Form).
- Serious with life-threatening or death no later than 7 calendar days
- Serious adverse events (not life-threatening/death) no later than 15 calendar days, but UNEXPECTED serious adverse reactions immediately.
- Non-serious adverse reactions within 90 calendar days.
We also suggest confirming queries with the relevant local regulatory authority for further needs.