PIDM (WHO Programme for International Drug Monitoring)

Where does a case report go after your regulator?

In one sentence

The PIDM is the WHO programme through which national pharmacovigilance centres pool their case reports in one global database, VigiBase.

Launched by the World Health Organization (WHO) in 1968 with ten pilot countries, it has 162 full and 20 associate members. Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre in Sweden, runs the operations: it keeps VigiBase, gives members the VigiFlow and VigiLyze tools free of charge, and screens the data for signals.

Where it sits

HostThe WHO, which admits members from its headquarters in Geneva
ProgrammePIDM: 162 full and 20 associate members, each a national pharmacovigilance centre (July 2026)
OperationsUppsala Monitoring Centre, a Swedish foundation and WHO Collaborating Centre since 1978
DatabaseVigiBase: more than 40 million reports from over 180 membersThe world’s largest source of post-marketing safety data

Think of it like this

Think of weather stations in every country sending their readings to one archive. A storm that looks like a local fluke in one station’s log is a pattern when all the logs sit side by side.

Key insights

A programme, run by a foundationMembership is earned with dataThe obligation and the returnSignals from the whole world

The WHO Programme for International Drug Monitoring (PIDM) is a collaboration launched in 1968 to monitor the safety of medicines and vaccines: a forum for WHO member states, territories and areas. The WHO hosts it and admits the members; Uppsala Monitoring Centre handles the operations as the WHO Collaborating Centre.

A country applies to WHO headquarters in Geneva with a recognised pharmacovigilance entity, usually inside its regulator, and a programme for collecting case reports. Accepted, it is an associate member. Once its sample reports in the E2B format of the International Council for Harmonisation (ICH) prove compatible and regular sharing is authorised, it becomes a full member. Chapter 2 follows one report through the system.

Members must contribute data to VigiBase regularly and are encouraged to share the signals they find. In return they get the tools free of charge: VigiFlow to collect and manage reports nationally, VigiLyze to analyse them against the world. The members’ countries hold nearly 99 percent of the world’s population.

VigiBase exists to provide evidence from which signals can be identified and communicated. UMC’s signal team screens it, and a member with a small national dataset can use the global one to see a signal invisible at home. In May 2026 the World Health Assembly adopted resolution 79.11 on smart, efficient pharmacovigilance; the 44th annual meeting of the members followed in September.

Jump to: 1 Three moments 2 Your report, their database 3 What the network adds to the law 4 Test yourself

Chapter 1

Which three moments made the PIDM what it is?

Pick a year. Each added a layer between the national centre and the world.

1968Ten countries pool their reports1978Uppsala takes the operations2026The Assembly votes again

Ten countries pool their reports

In 1963 the sixteenth World Health Assembly, in resolution 16.36, called for a systematic collection of information on serious adverse drug reactions, above all once medicines were in public use. The programme followed in 1968. Its 1968 pilot had ten members: Australia, Canada, Czechoslovakia, the Federal Republic of Germany, Ireland, the Netherlands, New Zealand, Sweden, the United Kingdom and the United States.

The idea has not changed: each country keeps its own centre and sends its case reports to one shared database, so that a reaction too rare for one country to notice shows in the whole. Japan joined in 1972, France in 1986, China and India in 1998, Brazil in 2001.

What it left behind: the habit of sending every report twice, once to the regulator and once to the world.

Uppsala takes the operations

In 1978 the Government of Sweden and the WHO agreed to set up Uppsala Monitoring Centre, an independent, self-funded, non-profit foundation that operates the programme as the WHO Collaborating Centre for International Drug Monitoring. The agreement was amended in 2001; since then the WHO and Sweden each appoint three members of its board. It finances itself by selling pharmacovigilance products and services, and has around 200 staff.

Its first charge is VigiBase, the global database, held in standardised terminologies: WHODrug Global, the medicine dictionary UMC itself maintains, and MedDRA for the reactions. Around it grew the tools members use free of charge, a web application opened to the public in April 2015, and in 2018 the programme marked fifty years at WHO headquarters.

What it left behind: a database with a keeper, and a keeper that pays its own way.

Smart pharmacovigilance, by resolution

On 22 May 2026 the seventy-ninth World Health Assembly adopted resolution 79.11, on advancing smart, efficient pharmacovigilance as an essential tool for resilient health systems. It calls on Member States to strengthen and integrate the monitoring of medicines, vaccines and other health technologies, to build regulatory capacity, and to use digital tools and real-world data; it stresses timely signal detection, risk communication and the countering of misinformation.

Four months later, from 25 to 27 September 2026, the 44th annual meeting of the members gathered more than 145 professionals from 67 countries in San José, Costa Rica, on communication as a tool of pharmacovigilance. The programme stood at 162 full members and 20 associates, Belize the newest.

What it left behind: a mandate from the Assembly itself, sixty-three years after the first one.

Chapter 2

Your report, their database

A case report has left your hands. Two questions decide where the programme takes it: who is holding it, and is it being filed or analysed? Pick a cell.

At the national centreAt UppsalaBeing filedFiled, nationallyFiled, globallyBeing analysedAnalysed, nationallyAnalysed, globally

Or the question is a different one: how a country joins or what the public can see

Filed globally, the report is one of more than 40 million in VigiBase, the WHO database of adverse event reports for medicines and vaccines, from over 180 members. Each report is checked against minimum criteria and coded in WHODrug Global and MedDRA; the database exists to provide evidence from which signals can be identified. UMC, About VigiBase

Filed nationally, in a member that uses UMC’s tools, the report sits in VigiFlow: one national database fed by web and mobile forms for health workers and the public, a desktop form for paper and phone reports, and an industry module that takes ICH E2B files from marketing authorisation holders. It then flows on to VigiBase. UMC, VigiFlow data collection

A country joins by a formal application to WHO headquarters in Geneva, naming a pharmacovigilance entity recognised by its health ministry, usually inside the regulator. Accepted, it is an associate member. It then sends sample reports in the ICH E2B format; when UMC confirms they are robust and compatible, regular sharing is authorised and the WHO confirms full membership. UMC, How to join the programme

Analysed at the national centre, the report meets VigiLyze, the signal management application that puts national data in global context: disproportionality analysis and hypothesis generation on VigiBase, so that a country with a small dataset can see a signal that its own data could not show. UMC, VigiLyze

Analysed globally, the report is part of what UMC’s signal management team screens. A signal is information about a new or known adverse event that may be caused by a medicine or vaccine; the team detects, assesses and communicates them from VigiBase, and members can see the signals UMC identified or other members shared. UMC, Signal management; UMC, VigiLyze

What the public sees is VigiAccess, the web application the WHO launched in April 2015 so that anyone can look up the reported adverse effects of a medicine, and be encouraged to report their own. The medicine itself is named in WHODrug Global, the dictionary UMC maintains and releases each March and September. WHO, Programme for International Drug Monitoring; UMC, What is WHODrug Global

Membership also brings obligations, including regularly contributing data to VigiBase, the WHO global database of adverse event reports for medicines and vaccines. Members are encouraged to share any safety signals they identify, contributing to a network of mutual reliance where members can turn to each other for support.
UMC, Membership benefits

The programme has no inspector and no fine. Its only lever is the one that built it: a country that stops sending data stops seeing the world’s.

Chapter 3

What does the network add to the law?

Reporting is required by national law. Five things the law never gave a national centre.

	The law	The programme
Where a report ends up	In the national database of the regulator that received it	In VigiBase as well, beside 40 million reports from over 180 members
A rare reaction	Seen only if the country’s own data are large enough	Seen in the global data through VigiLyze, even where national data are too small
The tools	Each regulator buys or builds its own system	VigiFlow, VigiLyze and the reporting apps, free of charge to every member
Who else is looking	The regulator’s own assessors	UMC’s signal team screening VigiBase, and members encouraged to share their signals
The mandate	A national pharmacovigilance act or regulation	Two Assembly resolutions, 1963 and 2026, and an annual meeting of the members

Show the references

Where a report ends up: WHO, Programme for International Drug Monitoring; UMC, About VigiBase.
A rare reaction: UMC, VigiLyze.
The tools: UMC, Membership benefits; UMC, VigiFlow data collection.
Who else is looking: UMC, VigiLyze; UMC, Signal management; UMC, Membership benefits.
The mandate: WHO, Programme for International Drug Monitoring (resolution 16.36); WHO, Pharmacovigilance (resolution 79.11, 44th annual meeting).

The law makes a country collect its reports. The programme makes them count for everyone else.

The facts, in one place

What it is	A WHO collaboration since 1968 through which national pharmacovigilance centres share their case reports in one global database and work together on medicines and vaccine safety.
Since	1968, a pilot of ten countries, after the World Health Assembly’s resolution 16.36 of 1963.
Who decides	The WHO admits members from its headquarters in Geneva; the members meet once a year, the 44th time in September 2026.
Operations	Uppsala Monitoring Centre, an independent, self-funded Swedish foundation set up by Sweden and the WHO in 1978, with a board of six appointed half by each and around 200 staff.
Members	162 full and 20 associate members in July 2026, whose countries hold nearly 99 percent of the world’s population.
Database	VigiBase: more than 40 million reports in February 2025, coded in WHODrug Global and MedDRA, with VigiAccess as the public window since 2015.
Tools	VigiFlow for national collection and case management, VigiLyze for signal work on the global data, offered to members free of charge.

Don’t confuse it with: Uppsala Monitoring Centre

PIDM

The programme

Is: the WHO’s network of national pharmacovigilance centres, 182 members in all
Decides: the WHO admits members; the members meet annually and send recommendations
Example: Belize becomes a full member after its reports reach VigiBase

UMC

The operator

Is: a self-funded Swedish foundation, the WHO Collaborating Centre that runs the programme’s operations
Decides: its own products and services, under a board appointed by the WHO and Sweden
Example: keeps VigiBase, screens it for signals, sells WHODrug subscriptions

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A company can report an adverse reaction straight to VigiBase.”

MythTruth

MythYou got it.Not quite.

The members of the programme submit the reports: the national pharmacovigilance centres. A company reports to the national centre, which shares the data with VigiBase.

“A country is only a full member once its reports have actually reached VigiBase.”