Latest Country Level Reporting Requirements in Pharmacovigilance
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Latest Country Level Reporting Requirements in Pharmacovigilance | |
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Related Certifications | Certificate in Current Pharmacovigilance Regulatory Landscape |
This page maintains latest changes in Pharmacovigilance Regulatory Reporting Requirements by Country.
United States | ||
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PV Scope | Requirement | Effective date |
Adverse drug reactions reporting | In general, manufacturers, packers, distributors and applicants with approved applications for new drugs for human use, manufacturers, packers and distributors of licensed biological products, and persons identified on the label as the manufacturer, packer, or distributor of prescription drugs marketed for human use without an approved application are required to submit postmarketing safety reports of Adverse Drug Reactions to FDA. A report of Adverse Drug Reaction that is both serious and unexpected must be made to FDA as soon as possible, but no later than 15 days after receiving information about the event. Persons required to file such 15-day Alert reports are also required to investigate and submit any new information to FDA. [1]
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May 20, 2010 |
ADR reporting for HCT/Ps | An adverse reaction for human cells, tissues, and cellular and tissue-based products (HCT/Ps) is defined as a noxious and unintended response to any HCT/P for which there is a reasonable possibility that the HCT/P caused the response. Whenever an HCT/P recipient experiences an unintended response, there may be multiple possible causes, but, if one of the reasonable possibilities is that the HCT/P caused the response, then this would meet the definition of adverse reaction.
The examples of HCT/Ps that are subjected to adverse reaction reporting are: Amniotic membrane, bone, cartilage, cornea, fascia, ligament, pericardium, hematopoietic stem/progenitor cells derived from peripheral blood, hematopoietic stem/progenitor cells derived from cord blood, sclera, skin, tendon, vascular graft, heart valve and dura mater. Manufacturers need to, as soon as practical, investigate all adverse reactions that are the subject of these 15-day reports and must submit to FDA follow-up reports within 15 calendar days of the receipt of new information or as requested by FDA. If additional information is not obtainable, a follow-up report may be required that describes briefly the steps taken (e.g., phone call, email, registered mail) to seek additional information and the reasons why it could not be obtained. [2] |
March 03, 2016 |
AE Reporting for Outsourcing Facilities | Minimum criteria for reporting AE which outsourcing facility should meet for a valid report is identifiable patient, reporter, suspect drug and SAE. The facility must submit the report as a 15-day “Alert report” to FDA as soon as possible, but no later than 15 calendar days after first receiving information about the adverse event. Reports should be submitted as long as the outsourcing facility has information on at least the suspect drug and the adverse event. [3]
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October 2015 |
European Union | ||
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PV Scope | Requirement | Effective date |
Solicited reports | Solicited reports of suspected adverse reactions, which should be considered as spontaneous, are suspected adverse reactions in relation to those adverse events for which the protocol of non-interventional post-authorization studies provides differently and does not require their systematic collection and suspected adverse reactions originating from compassionate use or named patient use conducted in the Member States where the active collection of adverse events occurring in these programmes is not required. For the purpose of safety reporting, solicited reports should be classified as study reports and should have an appropriate causality assessment to consider whether they refer to suspected adverse reactions and therefore meet the criteria for reporting.
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September 16, 2014 |
Follow-up of reports | The suspected adverse reactions reports may contain incomplete information and therefore they should be followed up, especially in the cases of events of special interest, prospective reports of pregnancy, cases notifying the death of a patient and cases reporting new risks or changes in the known risks.
... The use of targeted specific forms for the collection of missing information in the local language should avoid requesting the primary source to repeat information already provided in the initial report and/or to complete extensive questionnaires, which could discourage future spontaneous reporting. |
September 16, 2014 |
Reporting of overdose, abuse, off-label use, misuse, medication error or occupational exposure | Medication error is defined as any unintentional error in the prescribing, dispensing, or administration of a medicinal product while in the control of the healthcare professional or consumer. Reports associated with suspected adverse reactions should be subject to reporting in accordance with the criteria outlined in VI.B.7. and with the electronic reporting requirements described in VI.C.6.2.3.3. These reports should be routinely followed-up to ensure that the information is as complete as possible with regards to the symptoms, treatments, outcomes, the context of occurrence (e.g., error in prescription, administration, dispensing, dosage, unauthorized indication or population, etc.).
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September 16, 2014 |
Reports of suspected adverse reactions originating from organized data collection systems and other systems | Individual case safety reports (ICSRs) originating from post-authorisation studies need to contain information on study type, study name and the sponsor’s study number or study registration number. [4]
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September 16, 2014 |
Expedited reporting time frames | Serious valid ICSRs shall be reported by competent authorities in the Member States or by marketing authorisation holders within 15 days from the date of receipt of the reports. Non-serious valid ICSRs shall be reported by competent authorities in the Member States or by marketing authorisation holders within 90 days from the date of receipt of the reports. [5]
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June 22, 2012 |
Submitting variations | Marketing authorization holders of human medicinal products are not required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance and the Pharmacovigilance System Master File. [6] | February 1, 2016 |
India | ||
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PV Scope | Requirement | Effective date |
Serious Adverse Events (SAEs) reporting in clinical trials | All SAEs occurring in clinical trials should be reported as per the details provided in Appendix XI of Schedule Y (Annexure I) within the applicable timeline (14 calendar days), to the Drugs Controller General (India). Pharmaceutical company / the sponsor / CRO (Investigator in investigator-initiated studies) is responsible for reporting SAEs within the applicable timelines. As per the regulations (Schedule Y of Drugs & Cosmetics Rules), all unexpected SAEs have to be reported to CDSCO within 14 calendar days. [7]
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May 11, 2011 |
SAEs reporting in clinical trials | In the case of SAE not reported within 24 h of occurrence, the investigator needs to provide reasons for the delay along with the report of the SAE. [8]
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December 12, 2014 |
SAEs reporting in clinical trials | The checklist for submission of SAE occurring in clinical trial is revised with new requirements like submission of signed informed consent form, IB and protocol which comes along with every submission of death case. It also requires unblinded data to be submitted for every death case. [9]
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January 30, 2013 |
Brazil | ||
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PV Scope | Requirement | Effective date |
Serious adverse events reporting | In cases of serious adverse events, the MAH should notify the Health Surveillance Brazilian System (SNVS) Health Surveillance Notification and Investigation System on an expedited basis, because all information cannot be evaluated with the same degree of priority, despite the fact that pharmacovigilance consolidated reports are periodically forwarded. [10]
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August, 2009 |
United Kingdom | ||
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PV Scope | Requirement | Effective date |
Yellow Card reporting guidelines for ADRs in adults or children | The advice on which suspected ADRs to report in children is the same as for adults (MHRa recommends to do not report all suspected ADRs in children). All suspected ADRs that are serious or result in harm and all suspected ADRs associated with new drugs and vaccines (identified by the black triangle symbol) should be reported via Yellow Card. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalization, and those that are considered medically significant for any other reason. [11]
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September 25, 2014 |
Reporting suspected ADRs to vaccines and biological medicines | When reporting a suspected ADR to a biological medicine (such as blood products, antibodies and advanced therapies (such as gene and tissue therapy)) or vaccine, in addition to the substance, the brand name (or product licence number and manufacturer), and the specific batch number, on the report should be provided to ensure product/brand-specific pharmacovigilance is correctly performed.
Additionally, when providing patients with details of the vaccine or biological medicine administered, giving the details of the brand and batch number will allow patients and carers to more accurately report suspected ADRs to MHRA. [12]
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November 22, 2012 |
Reporting of suspected ADRs for Black Triangle (▼) medicines | If a medicine carries a Black Triangle (▼), this means that it is subject to intensive monitoring. A Black Triangle is assigned to a medicine if:
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May 29, 2013 |
References
- ↑ http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212056.pdf
- ↑ http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM434834.pdf
- ↑ http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm434188.pdf
- ↑ http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/09/WC500172402.pdf
- ↑ http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123203.pdf
- ↑ http://ec.europa.eu/health/files/pharmacovigilance/2016_01_18__variations_article_57_database.pdf
- ↑ http://www.cdsco.nic.in/writereaddata/sae%20guidelines%2005-05-2011.pdf
- ↑ http://www.cdsco.nic.in/writereaddata/Notificatiohn%20on%20Compensation%20on%20clincial%20trial%20(1).pdf
- ↑ http://cdsco.nic.in/writereaddata/procedure%20for%20prescreening%20and%20checklist%20_final%20on%2022-04-2014.pdf
- ↑ http://portal.anvisa.gov.br/documents/33868/2894051/Periodical_Pharmacovigilance_Report.pdf/ceee3b13-b2f6-48fe-ba3c-bf463c4c40b6?version=1.0
- ↑ https://www.gov.uk/drug-safety-update/new-guidance-on-reporting-suspected-adverse-drug-reactions-in-children
- ↑ https://www.gov.uk/drug-safety-update/reporting-suspected-adverse-drug-reactions-to-vaccines-and-biological-medicines
- ↑ https://www.gov.uk/drug-safety-update/black-triangle-medicines-part-of-an-eu-wide-scheme