Reference
Case processing requirements, submission methods, databases, and timelines for 18 authorities across the Americas, Europe, Africa, Asia-Pacific, and the Middle East — sourced from official regulatory guidance, not summarized secondhand.
Where they sit
Every authority on this page, plotted at its headquarters city. Hover a marker for the name, or click through to jump straight to its full entry.
Approximate headquarters locations, not precise cartography \u2014 hover or tap a marker, or click through to jump straight to that authority below.
At a glance
The numbers people actually need to remember — expand any authority below for the full picture.
| Authority | Database | Format | Serious ICSR timeline |
|---|---|---|---|
| FDA | AEMS | E2B(R3) | 15 calendar days |
| EMA | EudraVigilance | E2B(R3) | As soon as possible, no later than 15 calendar days |
| MHRA | Yellow Card Scheme | E2B(R3) | 15 calendar days |
| PMDA | JADER | E2B(R3) | 7 or 15 calendar days depending on severity/expectedness |
| Health Canada | Canada Vigilance | E2B(R3) | 15 calendar days |
| CDSCO / PvPI | VigiFlow → VigiBase | VigiFlow / E2B-aligned | Within 24 hours |
| TGA | DAEN | E2B(R2) only | 14 calendar days (reduced from 90 days in August 2021) |
| Swissmedic | Swissmedic PV database | E2B(R3) | 15 calendar days |
| NMPA | National ADR Monitoring Network | E2B(R2) | Within 24 hours to both the MAH’s own system and NCADRM |
| HSA | PRISM | CIOMS-I / MedDRA-coded | 7 calendar days |
| MFDS | KAERS | ICSR / E2B-aligned | 15 days from the incident, required since 2003 |
| ANVISA | VigiMed | E2B (ICH E2B XML) | 15 calendar days, regardless of whether the report is spontaneous, solicited, from a consumer, or from a health professional |
| SFDA | NPC database | ICH E2D-aligned | 15 calendar days |
| SAHPRA | VigiFlow (SA) | E2B / CIOMS | 7 calendar days |
| MOHAP | MOHAP PV database | E2B-aligned | 7 calendar days |
| Medsafe | NZ Pharmacovigilance Database | CIOMS / structured form | Reporting is voluntary and "no fault" — encouraged as soon as possible, not bound to a fixed-day clock the way mandatory manufacturer reporting is elsewhere |
| COFEPRIS | SISCE / CNFV database | Structured form (NOM-220) | Immediately, no later than 7 calendar days |
| WHO-UMC | VigiBase | E2B-aligned | Set by each national centre’s own schedule, not a single global clock |
In depth
Tap any authority for its full case processing requirements, submission method, legal basis, and complete timeline breakdown.
Database
AEMS — Adverse Event Monitoring System. Launched March 11, 2026, replacing the six legacy databases FAERS, VAERS, and AERS fed into (MAUDE, HFCS, and CTPAE followed by end of May 2026). "FAERS" now redirects to AEMS on fda.gov; expect the name to linger in casual use for a while.
Submission gateway
ESG NextGen (Electronic Submissions Gateway Next Generation) — the successor to the legacy ESG
Format
E2B(R3) becomes mandatory for postmarketing ICSRs on October 1, 2026 (premarketing/IND ICSRs already required since April 2024); E2B(R2) accepted during a 2-year transition window but can’t be reverted to once a company starts submitting in R3.
Legal basis
21 CFR 314.80 (drugs), 21 CFR 600.80 (biologics), 21 CFR 312.32 (IND safety reports)
Timelines
Case processing
Manufacturers must report adverse events they become aware of for their own marketed products, and — since the 2007 FDA Amendments Act — must also report events associated with another manufacturer’s product if their own product is named as a suspect alongside it. Day zero of the clock is the date any personnel of the responsible company first receives the minimum information for a valid case: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event.
Submission method
Voluntary reports from clinicians, patients, and consumers still reach FDA through MedWatch — Form 3500 (professionals) or 3500B (consumers) — which now feeds into AEMS rather than the legacy FAERS database. Manufacturers submit mandatory reports electronically via ESG NextGen; paper is a legacy fallback only.
The single biggest operational change with AEMS isn’t the name, it’s the publication cadence: FAERS released data quarterly, sometimes weeks or months behind what FDA already held internally. AEMS publishes in real time as reports are submitted (subject to patient privacy screening) — a signal-detection workflow built around quarterly FAERS exports needs rethinking, not just a find-and-replace on the database name. AEMS is still spontaneous-report-only, same as FAERS was, so it still has no exposure data of its own — that’s what FDA’s separate Sentinel Initiative supplies, drawing on real-world claims and EHR data, unaffected by the AEMS transition. Also worth flagging explicitly: FDA’s new AEMS and Australia’s TGA "AEMS" (Adverse Event Management System, further down this page) are two completely unrelated systems that happen to share the same acronym — a genuinely confusing coincidence worth not tripping over in an interview.
Database
EudraVigilance
Submission gateway
EVWEB (manual entry) or Gateway (system-to-system, for higher-volume senders)
Format
ICH E2B(R3), mandatory — GVP Module VI Rev. 2 (effective November 2017) formalized the shift from the legacy R2 format
Legal basis
Directive 2001/83/EC, Regulation (EC) No 726/2004, GVP Module VI
Timelines
Case processing
A report only qualifies once it clears GVP Module VI’s validity check: an identifiable reporter, an identifiable patient, at least one suspect medicinal product, and at least one adverse reaction. The clock starts the moment any personnel of the marketing authorisation holder — anywhere in the organisation, including sales or medical affairs, not just the safety team — becomes aware of a case meeting that bar.
Submission method
All ICSRs go to EudraVigilance electronically; there is no accepted paper pathway. Since September 2025, EMA runs automated compliance monitoring through EVDAS, issuing monthly reports to marketing authorisation holders and national authorities tracking adherence to the 7/15/90-day clocks.
One database, one submission point for the entire EU/EEA — a marketing authorisation holder doesn’t submit separately to each member state’s national agency for centrally reported cases; EudraVigilance is the shared system national competent authorities also draw from.
Database
Yellow Card Scheme — one of the world’s oldest spontaneous reporting systems, running since 1964
Submission gateway
MHRA Gateway (AS2 system-to-system) for higher-volume senders, or the ICSR Submissions web portal for manual/lower-volume submission
Format
ICH E2B(R3), based on the EMA reporting rule set adapted post-Brexit as the MHRA Rule Set. Legacy R2 XML is still accepted and converted.
Legal basis
Human Medicines Regulations 2012 (as amended post-Brexit)
Timelines
Case processing
Post-Brexit, Great Britain and Northern Ireland split: GB serious and non-serious ICSRs come through the MHRA Gateway directly, while Northern Ireland cases — still under the EU’s framework — are pulled from EudraVigilance rather than submitted separately.
Submission method
Registration for either the Gateway or the ICSR Submissions portal typically completes within 5 working days. Fax and post are not accepted for CIOMS I forms; if the Gateway itself goes down, MHRA publishes official downtime windows and reports submitted within 2 business days of restoration are treated as compliant against the original failure date.
The Yellow Card Scheme’s age is not just trivia — it’s one of the reasons UK spontaneous-reporting culture and terminology (e.g. "Yellow Card reports") shows up as shorthand across the wider PV industry even outside the UK.
Database
JADER — Japanese Adverse Drug Event Report database, public since 2012
Submission gateway
Direct submission per PMDA’s own format specification; a Japan-resident in-country representative must submit on behalf of any sponsor without a Japanese presence
Format
ICH E2B(R3); the domestic case creation process is distinct enough that most global safety databases treat Japan as a localized case type rather than a simple pass-through
Legal basis
Article 80-2-6, Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "PMD Act")
Timelines
Case processing
A sponsor without a physical presence in Japan cannot report directly — an in-country representative or agent has to submit on the sponsor’s behalf, which is a genuinely distinctive operational requirement compared to the other authorities on this page.
Submission method
Electronic submission follows PMDA’s own E2B(R3) implementation guide; global safety-database vendors typically build a dedicated "Japan Domestic Case" workflow rather than reusing the same localization logic used for other markets.
JADER is a spontaneous reporting database, similar in role to FAERS or the Yellow Card Scheme — Japan’s case processing distinctiveness is mostly about who can submit and the domestic-case workflow, not the underlying database philosophy.
Database
Canada Vigilance Adverse Reaction Database, public since 1965, run by the Marketed Health Products Directorate
Submission gateway
MedEffect Canada, the expected standard for any marketing authorisation holder with meaningful case volume
Format
ICH E2B(R3) — Health Canada has fully decommissioned acceptance of the legacy E2B(R2) structure for industry submissions
Legal basis
Food and Drugs Act and Regulations
Timelines
Case processing
Reports route through one of six regional Canada Vigilance offices or the national centre in Ottawa. A valid report needs four minimum elements: patient information (without using the patient’s name), a description of the reaction, the suspected product, and reporter contact details.
Submission method
Voluntary reports from health professionals and consumers can go in online, by phone, fax, or mail; mandatory manufacturer reports go through MedEffect Canada electronically. Any safety database still generating R2-format output for Canadian submissions is out of compliance — this is a hard cutover, not a grace-period transition.
Canada Vigilance’s scope is broader than most peer databases — it covers natural health products and disinfectants with disinfectant claims alongside conventional drugs and biologics, not just prescription medicines.
Database
VigiFlow (case management, feeding into WHO’s VigiBase) — over 1,120 ADR Monitoring Centres (AMCs) as of October 2025
Submission gateway
SUGAM (CDSCO’s online portal for new drug, clinical trial, and licensing submissions) for regulatory filings; AMCs feed ADR cases into VigiFlow directly
Format
Reports flow through VigiFlow into VigiBase; CDSCO periodic safety reporting (PSUR/PMS) follows its own domestic cadence distinct from EMA’s PBRER cycle
Legal basis
Drugs and Cosmetics Act & Rules, 1945; New Drugs and Clinical Trials (NDCT) Rules, 2019
Timelines
Case processing
PvPI is the operational programme; CDSCO is the regulator it reports to. The Indian Pharmacopoeia Commission (IPC) in Ghaziabad has run PvPI’s National Coordination Centre since April 2011 (AIIMS New Delhi was the original coordinator at the 2010 launch). Each AMC enters cases into VigiFlow, which forwards them to PvPI/IPC nationally and onward into VigiBase via WHO-UMC.
Submission method
Clinical trial SAEs run on the compensation-linked chain above — a structure genuinely distinct from spontaneous post-marketing ADR reporting, which instead flows through the AMC network into VigiFlow on an ongoing basis rather than against a single event’s clock.
A large share of the global PV workforce is India-based, supporting US/EU sponsors — but interviews for India-facing CRO and pharma roles specifically test this domestic framework, not just ICH/EMA/FDA content, so the two-track structure (spontaneous ADR via AMCs vs. clinical trial SAE via the compensation chain) is worth knowing cold.
Database
DAEN — Database of Adverse Event Notifications (separate databases for medicines and medical devices, both public)
Submission gateway
AEMS (Adverse Event Management System) web portal, or E2B(R2) EDI for system-to-system submission
Format
E2B(R2) only — TGA has not yet adopted R3 and has published no committed timeline for doing so, which makes it a genuine outlier among major authorities on this page
Legal basis
Therapeutic Goods Act 1989
Timelines
Case processing
Reports are suspected associations, not confirmed causal findings, and DAEN says so explicitly on every search result — a distinction worth internalizing, since it’s the same epistemic caveat that applies to every spontaneous reporting database, just stated more plainly here than most.
Submission method
Medicine and vaccine ICSRs go through E2B(R2) EDI or the AEMS web portal; medical device adverse event reports are handled through a completely separate pathway — the E2B standard doesn’t accommodate device incidents at all, so device sponsors submit through the dedicated Sponsors/Manufacturers medical device incident report page instead.
The R2-only format is the detail most likely to trip up someone used to other majors — don’t assume every ICH-aligned authority has moved to R3 just because the largest ones have. Also worth knowing: TGA’s "AEMS" (this system, Adverse Event Management System) and the FDA’s new "AEMS" (Adverse Event Monitoring System, launched March 2026) are two entirely unrelated platforms that happen to share the same acronym.
Database
Swissmedic’s national pharmacovigilance database, fed by the National Pharmacovigilance Centre and regional centres
Submission gateway
B2B Gateway for higher-volume senders (E2B(R3), transition from R2 completed 30 June 2026), or ElViS (Electronic Vigilance System) for smaller companies and healthcare professionals without their own database connection
Format
E2B(R3) via the Gateway as of mid-2026; ElViS is expected to support R3 by the end of 2026 but currently remains R2-only, so which channel a company uses actually determines which format version applies
Legal basis
Therapeutic Products Act (Heilmittelgesetz) and its ordinances
Timelines
Case processing
Since 1 July 2021, Swissmedic accepts electronic reports only — via the Gateway or ElViS, no paper fallback for marketing authorisation holders. ElViS is a submission portal, not a database of record: an unfinalised report is only held there for a limited window, so relying on it as long-term storage for a draft case is a mistake.
Submission method
The Gateway is reserved for higher-volume senders; ElViS is the designed-for-purpose route for smaller pharmaceutical companies and for healthcare professionals reporting directly. MedDRA coding is required in ElViS for fields like diagnosis and reaction, but the portal doesn’t supply a MedDRA browser or dropdown — terms have to be copied in from the company’s own MedDRA tooling.
Switzerland sits outside the EU but tracks EMA’s reporting philosophy closely (Swissmedic explicitly models its E2B approach on EMA business rules) — worth knowing as the near-EU-equivalent case in interviews that ask about non-EU European markets specifically.
Database
National Adverse Drug Reaction Monitoring Information Network, run through the National Center for ADR Monitoring (NCADRM) with Provincial and Prefectural centres beneath it
Submission gateway
Direct reporting system operated by each Marketing Authorization Holder (MAH), connected to the national network; MAHs report directly rather than solely relying on distributor pass-through as of January 2019
Format
E2B(R2) implementation for domestic and international ICSR reporting; MAHs must translate non-Chinese-language source cases into Chinese before entry
Legal basis
2019 Drug Administration Law, 2021 Good Pharmacovigilance Practices (GVP), 2026 Implementing Regulations
Timelines
Case processing
A four-tier structure — national (NCADRM), provincial (PCADRM), prefectural, and county-level centres — actually collects reports on the ground, with each tier verifying, analysing, and forwarding upward. MAHs are also required to watch specifically for "clustering" — multiple similar-symptom cases surfacing in a short window from the same or adjacent product batches — and to investigate promptly when that pattern appears, which is a distinctly China-specific proactive obligation beyond routine case processing.
Submission method
Since the NMPA’s September 2018 policy shift, MAHs report directly rather than depending on distributors to relay cases — a real reallocation of responsibility onto the marketing authorisation holder’s own PV system.
PSMF is required and inspectable, matching the EU/ICH pattern, but the batch-clustering surveillance obligation and the mandatory direct-reporting shift are the two details that distinguish China’s framework from a simple "ICH-aligned" checkbox.
Database
HSA’s internal vigilance database, fed through the PRISM portal and, for clinical trials, its Expedited Safety Reporting (ESR) module
Submission gateway
PRISM (Pharmaceutical Regulatory Information System) for marketed-product ICSRs and new safety information; the ESR module within PRISM specifically for clinical trial SUSARs
Format
CIOMS-I form, with MedDRA-coded reaction descriptions recommended
Legal basis
Health Products Act and related regulations, administered by HSA’s Vigilance and Compliance Branch
Timelines
Case processing
Reporting doesn’t stop at trial completion by default: unexpected serious ADR (USADR) submission can continue past Last Patient Last Visit if the protocol calls for it, and sponsors are expected to flag any newly emerging safety information relevant to previously treated participants even after the formal reporting window closes.
Submission method
While a registration application is still pending HSA review, the applicant carries an ongoing obligation to proactively push any new safety information affecting the product’s benefit-risk balance through PRISM or eCTD — not wait to be asked.
Singapore is a useful bridge case for anyone comparing frameworks: it aligns closely with ICH and WHO PIDM conventions while running its own named systems (PRISM, ESR) rather than adopting another authority’s platform wholesale, similar in spirit to how MHRA or Health Canada each run their own named infrastructure on a broadly ICH-aligned foundation.
Database
KAERS — Korea Adverse Event Reporting System, operated by KIDS (Korea Institute of Drug Safety and Risk Management) since 2012
Submission gateway
KAERS direct submission, or via ADR call centre, fax, and email for reporters without electronic access
Format
ICSR format aligned with international practice; KIDS forwards validated reports on to WHO-UMC
Legal basis
Pharmaceutical Affairs Act and the Regulation on Safety of Pharmaceuticals (MFDS ordinances)
Timelines
Case processing
Regional Pharmacovigilance Centres (RPVCs) sit between the reporter and KIDS, performing causality assessment on cases from their region before they roll up nationally — a structural layer worth noting since it’s a genuine intermediate assessment step, not just a pass-through mailbox.
Submission method
Anyone can report directly into KAERS — the general public, physicians, other healthcare professionals, RPVCs, and MAHs all have a route in, with call centre, fax, and email available for reporters who aren’t submitting electronically.
Korea has been a full WHO Programme for International Drug Monitoring member since 1998, one of the longer-standing memberships in the Asia-Pacific region, and KIDS’ forwarding of validated KAERS reports into VigiBase is a direct, established pipeline rather than an occasional data-sharing arrangement.
Database
VigiMed — Brazil’s national name for a VigiFlow deployment, replacing the legacy NOTIVISA platform; migration ran company-by-company rather than as a single cutover
Submission gateway
VigiMed direct entry for healthcare professionals, patients, MAHs, and clinical trial sponsors alike
Format
ICH E2B XML; MedDRA required for adverse event/reaction coding and WHODrug Global for medicine coding, including vaccines — any company still coding with the older WHO-ART terminology is expected to migrate to MedDRA
Legal basis
RDC No. 406/2020, updated by RDC No. 967/25 (published March 2025, effective March 18, 2026)
Timelines
Case processing
RDC No. 967/25 is a live transition as of this writing — companies should be actively checking the VigiMed Companion Guide and ANVISA’s ICH E2B XML creation instructions rather than assuming last year’s process still applies unchanged.
Submission method
A Brazilian QPPV and their deputy must be direct employees of the MAH — unlike some other markets, this role can’t be outsourced to a third-party subcontractor, a genuinely distinctive local requirement.
VigiMed being literally "VigiFlow, Brazil’s deployment of it" is a clean, concrete example of how WHO-UMC’s tooling gets adopted and renamed locally — the same underlying software choice India’s PvPI made, just under a different national name.
Database
National Pharmacovigilance Centre (NPC) database, accessed via the Saudi Adverse Event Reporting System (SAERS), publicly branded تيقظ ("Taqazh" / "Be Alert")
Submission gateway
SAERS online reporting for the public and healthcare professionals; MAHs report through their locally appointed Saudi QPPV
Format
Aligned with ICH E2D timelines; PSUR/PBRER cycle typically follows the EU Reference Date (EURD) list rather than a fully independent Saudi schedule
Legal basis
SFDA pharmacovigilance regulations administered through the NPC, established 2009
Timelines
Case processing
A Saudi-appointed QPPV, registered with the NPC, must submit local ICSRs directly to SFDA — the submission responsibility sits with that locally registered person specifically, not just "the company" in the abstract.
Submission method
A Safety Data Exchange Agreement (SDEA) is required between the MAH and its local distributor, formalising who reports what and on which timeline — standard practice in markets with a mandatory local-agent structure, worth remembering as a recurring pattern across GCC-region and similarly structured authorities.
One notable divergence from the Gulf-wide "Arab GVP" guidelines: SFDA doesn’t require PSURs for generic drugs, where the broader Arab GVP framework does — a detail easy to get backwards if you’re used to assuming stricter regional guidelines always apply uniformly to the national regulator sitting inside that region.
Database
Reports feed into VigiFlow, then onward to VigiBase — for over a decade, ADR reports went to the legacy National Adverse Drug Events Monitoring Centre (NADEMC) database via fax before the move to electronic E2B submission
Submission gateway
E-reporting portal for individual reporters; E2B(XML) direct submission for pharmaceutical companies; a downloadable ADR form (emailed) as a fallback route
Format
E2B(XML) for direct company reporting; the WHO-recommended structured yellow form and CIOMS forms remain in use for other reporter types
Legal basis
Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), and SAHPRA safety-reporting guidelines
Timelines
Case processing
A valid ADR report needs a suspected drug, a suspected reaction, a patient, and an identifiable reporter — the same four-element minimum used across most WHO PIDM-aligned frameworks. Technical staff at SAHPRA’s Pharmacovigilance Unit check MedDRA coding accuracy and confirm whether a reaction is already listed in the product’s package insert before committing a report to VigiBase.
Submission method
Consumers report through healthcare professionals by default, though direct self-reporting through the e-reporting portal is also available. Post-marketing and clinical-trial safety reporting run under separate, distinct SAHPRA guideline documents rather than one unified rulebook.
A 2023 completeness analysis of South African reports submitted to VigiBase found a mean vigiGrade completeness score of only 0.456, with just 11.3% of reports scoring above the 0.8 "well-documented" threshold — a genuinely useful real-world data point on how much spontaneous-reporting quality varies even within a single functioning national system, not a critique unique to South Africa.
Database
MOHAP’s national pharmacovigilance system, run by the PV Section within the Drug Department
Submission gateway
Direct reporting to MOHAP’s PV Section; Dubai and Abu Dhabi additionally run their own emirate-level reporting channels (Dubai Health Authority, Department of Health Abu Dhabi) alongside the federal system
Format
UAE Good Pharmacovigilance Practice Guidelines, modelled in part on EU GVP, applied alongside the wider Arab GVP framework
Legal basis
UAE Good Pharmacovigilance Practice Guidelines (Federal), Arab Good Pharmacovigilance Practices
Timelines
Case processing
The federal system sits alongside emirate-level health authorities — Dubai Health Authority and the Department of Health Abu Dhabi each run their own reporting channels for adverse reactions, medication errors, and AEFI within their emirate, layered on top of the federal MOHAP requirement rather than replacing it.
Submission method
Local companies without their own PV infrastructure are given a window (historically up to one year from appointment) to bring ADR case reporting into compliance — a transitional allowance worth knowing about rather than assuming every requirement applies with zero ramp-up.
The UAE is a useful representative case for the wider GCC: national requirements (UAE-GVP) sit inside a shared regional framework (Arab GVP) the same way EU member states operate within GVP Module VI — worth drawing that direct parallel when explaining the structure to someone unfamiliar with either.
Database
The New Zealand Pharmacovigilance Database, launched September 2023, replacing the Centre for Adverse Reactions Monitoring’s (CARM) original 1965 database — one of the oldest continuously-run national ADR systems in the world before the switch
Submission gateway
Online reporting via the Medsafe/CARM reporting form; anyone can report, not just healthcare professionals
Format
Structured reporting form; CARM’s medical assessors still perform causality assessment on non-routine reports after collection moved to Medsafe
Legal basis
Medicines Act 1981 and associated regulations
Timelines
Case processing
CARM and Medsafe deliberately split responsibilities after the 2023 database migration: Medsafe/CARM jointly run collection, coding, and storage through the new digital system, while CARM’s medical experts retained the specialised, higher-value role of causality assessment on the reports that need real clinical judgement rather than routine processing.
Submission method
New Zealand has one of the highest ADR reporting rates in the world per capita and per prescriber, and was one of ten founding members of the WHO Programme for International Drug Monitoring in 1968 — a genuinely early adopter relative to most national systems on this page.
The reporting culture point is worth remembering specifically: even world-leading reporting rates are estimated to capture only around 5% of actual adverse reactions occurring — a concrete, sourced number for the general "spontaneous reporting under-captures reality" point that’s otherwise easy to state only in the abstract.
Database
The National Center of Pharmacovigilance (CNFV), operating under COFEPRIS, is the receiving body; hospital and institutional pharmacovigilance programmes (e.g. SISCE at pediatric centres) feed into it
Submission gateway
Written notification by fax, email, or online form; clinical trial SAEs route through the sponsor’s pharmacovigilance officer directly to CNFV
Format
Governed by Mexican Official Standard NOM-220-SSA1-2016 ("Installation and Operation of Pharmacovigilance")
Legal basis
NOM-220-SSA1-2016
Timelines
Case processing
COFEPRIS built its modern PV capacity in partnership with WHO-UMC and PAHO (the Pan American Health Organization) specifically to strengthen its ability to receive and analyse ADR reports — a collaboration explicitly credited by Uppsala Reports, worth knowing as a concrete example of UMC’s capacity-building role beyond just running VigiBase.
Submission method
The two-stage clinical trial clock — a fast 24-hour flag followed by a more complete 15-day report — mirrors the shape of CDSCO’s 24-hour/14-day India structure covered earlier on this page, even though the exact day counts differ slightly. Worth noting as a recurring pattern (fast initial flag, slower complete report) rather than assuming every authority uses a single flat deadline.
NOM-220 is a binding Mexican Official Standard, not just guidance — the distinction matters in Mexican regulatory practice generally, where NOMs carry the force of law rather than being advisory best-practice documents.
Database
VigiBase — the world’s largest pharmacovigilance database, 32M+ ICSRs
Submission gateway
VigiFlow (the case-management tool WHO provides to national centres that don’t have their own, including PvPI in India)
Format
Alignment with ICH E2B core data elements; historically more format-flexible than the strict-R3 authorities, though the large majority of VigiBase reports are now E2B-compliant
Legal basis
Not a regulator in the FDA/EMA sense — UMC operates the WHO Programme for International Drug Monitoring under a cooperation agreement with WHO, aggregating national data rather than issuing its own binding reporting mandates
Timelines
Case processing
UMC doesn’t collect cases directly from reporters — national centres (FAERS, EudraVigilance, PvPI, and the rest) do that collection and validation under their own rules, then forward validated reports into VigiBase, most often using VigiFlow or their own database-to-database link.
Submission method
Analysis runs through VigiLyze for signal detection across the aggregated dataset, with WHO’s 2025 AI Hub adding machine-assisted triage on top of that as the volume of global reporting keeps climbing.
This is the aggregation point, not a submission destination in its own right for most working PV professionals — the operational reporting relationship almost everyone actually has day to day is with a national authority, which then feeds UMC, not the other way around.
Before you rely on any of this for a real submission
Timelines and format mandates change — E2B version requirements especially, as several authorities have moved from R2 to R3 in just the past couple of years. Treat this as a well-sourced training reference, and verify against the authority's own current guidance (linked in each authority's official regulatory documentation) before it informs a real case decision.