Latest Country Level Reporting Requirements in Pharmacovigilance

From Verify.Wiki
Jump to: navigation, search
PV certificate.png
Latest Country Level Reporting Requirements in Pharmacovigilance
Related Certifications Certificate in Current Pharmacovigilance Regulatory Landscape

This page maintains latest changes in Pharmacovigilance Regulatory Reporting Requirements by Country.

United States alt text
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]
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]
October 2015
European Union alt text
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.
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. 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.).
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]
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]
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 alt text
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]
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]
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]
January 30, 2013
Australia alt text
PV Scope Requirement Effective date
Serious ADRs reporting timeframes
All serious ADRs must be reported as soon as possible and in no case later than fifteen (15) calendar days from receipt by the sponsor. The clock for serious ADRs starts (as day 0) on the day that the four minimum data elements, in relation to the ADR report, are received by one or more of the following:
  • any personnel of the sponsor - including sales representatives;
  • the person responsible for pharmacovigilance or persons working for or with this person; or
  • where the sponsor has entered into a relationship with a second company for the marketing of, or research on, the suspected product, the clock starts as soon as any personnel of the primary sponsor receives the minimum information. Wherever possible, the timeframe for regulatory submission should be no longer than 15 days from the first receipt by the second company and explicit procedures and detailed agreements should exist between the sponsor and the second company to facilitate achievement of this objective.

The reporting time clock is considered to begin again when a sponsor receives additional clinical or medically relevant information for a previously reported serious ADR. This information must be reported as soon as possible and in no case later than fifteen (15) calendar days after receipt of the additional information.

If a sponsor receives additional information about a case initially classified as non-serious that indicates the case should be reclassified (e.g., from non-serious to serious), the sponsor must report the case as soon as possible, and in no case later that 15 calendar days after receipt of the information that led to the change in classification.

For suspected serious ADR cases occurring in Australia that are identified through screening the worldwide literature, the clock starts (day zero) when the sponsor becomes aware of a publication containing the four minimum data elements. It is preferable that a copy of the relevant published article (in English or an English summary/translation) is provided to the TGA at the time the initial AR report is made. However if the article is not available at this time, it must be provided to the TGA within 15 calendar days of submission of the AR report to the TGA. Where difficulty is experienced in meeting the 15 calendar day requirement for submission of the article, the TGA must be notified in writing prior to the 15 day period ending.
June 4, 2014
Brazil alt text
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]
August, 2009
United Kingdom alt text
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]
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]
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:
  • it contains a new active substance; new medicines or vaccines authorized on or after January 2011 are assigned a Black Triangle
  • it is a biological medicine (eg, a vaccine or a medicine derived from plasma)
  • it has been given a ‘conditional approval’ (enabling medicines to reach patients with unmet medical needs earlier than might otherwise be the case while ensuring that additional data on a product are generated, submitted, assessed, and acted on)
  • it is approved ‘under exceptional circumstances’ (where the company is unable to provide comprehensive data for safety and efficacy under normal conditions of use because, for example, the indication is so rare)
  • the company that markets the medicine is required to carry out additional studies (eg, to obtain data on long-term use or a rare side effect seen in clinical trials). [13]
May 29, 2013



Verification history

Retrieved from ""