PIC/S (Pharmaceutical Inspection Co-operation Scheme)

Who makes one inspector’s visit count for fifty-seven?

In one sentence

PIC/S is the voluntary network of medicines inspectorates that share one manufacturing rulebook and check that every member inspects alike.

A non-binding arrangement between 57 regulatory authorities in Good Manufacturing Practice (GMP), a Swiss association run from Geneva. Its guide is practically identical to the European Union (EU) guide, every member is assessed for equivalence and reassessed after, and the inspectors train each other. Since 2023 the mandate reaches beyond manufacturing: an Expert Circle on Good Pharmacovigilance Practices (GVP) first met in November 2025.

Where it sits

The members57 Participating Authorities, the GMP inspectorates of their countries
DecidesThe PIC/S Committee, one vote per authority, by consensus; an Executive Bureau between meetings
NetworkPIC/S: a convention of 1970 and a scheme of 1995, a Swiss association since 2004
For safetyExpert Circles on Good Pharmacovigilance Practices and Good Clinical PracticesThe newest of its specialist circles

Think of it like this

Think of restaurant inspectors from fifty cities who agree on one checklist, train together and audit each other. A kitchen passed in one city is trusted in the others, though each city still signs its own certificate.

Key insights

A network of inspectorsOne rulebook, two coversThe members are inspected tooBeyond manufacturing

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal arrangement between regulatory authorities in GMP for human and veterinary medicines, open to any authority with a comparable inspection system. It harmonises inspection procedures, trains inspectors and, it says, is the only organisation in the world that deals exclusively with GMP.

The PIC/S GMP Guide grew out of the World Health Organization’s guide. The European Union adopted it in the late 1980s and the two have been developed in parallel ever since; a change to one is made to the other, so the texts are practically identical. The differences are a term, authorised person instead of Qualified Person, and the removed references to EU directives.

Mutual trust rests on two things: cooperation is voluntary, and every member was assessed for equivalence before being admitted. Joining takes three to six years. Founding members were never assessed, so in 2000 a Joint Reassessment Programme began under which existing members are reassessed on a regular basis, with one audit checklist. Chapter 2 shows what that means for your site.

From 2023 the mandate expanded beyond GMP to the other good practices, with training and standards first. The current Expert Circles include Good Pharmacovigilance Practices and Good Clinical Practices beside active ingredients, distribution, blood and quality risk management; the first meeting of the two circles, for regulators only, was hosted by the United Kingdom’s agency in November 2025.

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

Chapter 1

Which three moments made PIC/S what it is?

Pick a year. Each widened the circle of inspectors who trust each other.

1970A convention of ten1995The scheme beside the treaty2023Beyond manufacturing

A convention of ten

In October 1970 the European Free Trade Association founded the Pharmaceutical Inspection Convention, signed in Geneva and in force from 1971, under the title Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. Its first members were the association’s ten countries at the time; Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia followed.

Its goals were six: mutual recognition of inspections, harmonised GMP requirements, uniform inspection systems, training of inspectors, exchange of information, mutual confidence. Its instrument was a GMP guide derived from the World Health Organization’s, which the EU took up in the late 1980s and has developed in parallel since.

What it left behind: the idea that an inspection in one country can be recognised in another, if the inspectors share a rulebook.

The scheme beside the treaty

By the early 1990s the convention had hit European law: an incompatibility meant no new country could join it. Australia was the last, in January 1993. So on 2 November 1995 the Pharmaceutical Inspection Co-operation Scheme was formed, a non-binding arrangement between authorities rather than a treaty between states, open to any authority with a comparable inspection system. Convention and scheme run in parallel and are referred to together as PIC/S.

In 2000 the Joint Reassessment Programme began, so that older members meet the same requirements as applicants. On 3 June 2003 the Committee decided to become a Swiss association; on 1 January 2004 PIC/S became independent with its own Secretariat, and in November 2004 it was registered in Geneva. The United States Food and Drug Administration joined in January 2011.

What it left behind: a membership that any equivalent inspectorate could earn, and a body that could inspect its own members.

Beyond manufacturing

From 2023 the mandate was expanded beyond GMP to the other good practices, training and standards first, under a new mission: to lead the development and implementation of inspection frameworks for human and veterinary medicines through harmonised standards and world-class training. The Expert Circles, where specialist inspectors draft guidance and train, gained two on Good Pharmacovigilance Practices and Good Clinical Practices.

Their first joint meeting, for regulators only, was hosted by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in London on 4 and 5 November 2025. On 1 January 2026 Jordan’s agency became the 57th Participating Authority, and a new Chairperson and Executive Bureau took office.

What it left behind: a GMP network with a pharmacovigilance table, for the first time in its history.

Chapter 2

Your site, their inspector

An inspection is coming to one of your sites. Two questions decide what PIC/S has to do with it: is the site manufacturing or distributing, and is it the rulebook you are asking about or the inspectorate itself? Pick a cell.

ManufacturingDistributionThe rulebookRules, makingRules, shippingThe inspectorateInspector, makingInspector, shipping

Or it is not an inspection at all: a batch with a defect or your pharmacovigilance system

A manufacturing site is inspected against the PIC/S GMP Guide, PE 009, now in its 18th version: Part I for medicinal products, Part II for active substances and the annexes. In the EU the inspector carries the EU guide; the two are practically identical. PIC/S, GM(D)P Harmonisation; Publications, PE 009-18

A wholesale site has a PIC/S Guide to Good Distribution Practice, reference PE 011, in force since 1 June 2014 and based on the EU guide. It is voluntary guidance within PIC/S, because not every Participating Authority is competent to inspect distribution; in the EU the GDP guide is binding. PIC/S, GM(D)P Harmonisation; Publications, PE 011-1

The inspectorate that visits a manufacturing site was itself assessed for equivalence before it joined, a process of three to six years with an auditor’s gap analysis, and is reassessed under the Joint Reassessment Programme that began in 2000. One audit checklist serves both, and results of the EU’s joint audit programme are accepted in return. PIC/S, Compliance; Accession Procedure

For a distribution site the answer depends on the country. Not all PIC/S authorities are competent for GDP inspections, which is why the distribution guide is voluntary; where the authority does inspect distribution, its Expert Circle on Good Distribution Practice is where its inspectors compare notes. PIC/S, GM(D)P Harmonisation; Expert Circles

A quality defect in a batch on the market goes into the PIC/S Rapid Alert and Recall System, which every member joins automatically and which is part of a wider system with the EU’s alert and recall partners. Inspection reports, too, are shared voluntarily between members to save duplicate visits. PIC/S, Benefits

Your pharmacovigilance system is still inspected by your own authority under its own rules. What is new is the room: since 2023 the PIC/S mandate reaches beyond GMP, and the Expert Circle on Good Pharmacovigilance Practices, with its twin on Good Clinical Practices, held its first meeting in London in November 2025, for regulators only. PIC/S, International Co-operation; Expert Circles; home page, November 2025

Mutual trust is a key value in PIC/S and largely relies on the concept of: a) voluntary co-operation (there is no legal obligation under PIC/S) and b) each Member being assessed for equivalence before being admitted.
PIC/S, Mission, Vision and Values

Nothing in the scheme binds anyone, which is exactly why every member has to prove it inspects like the others.

Chapter 3

What does the network add to the law?

Each authority inspects under its own law. Five places where PIC/S added what the law could not.

	The law	The network
The GMP rulebook	The EU guide binds in the EU; other countries write their own	One guide, practically identical to the EU’s, used by 57 authorities on five continents
The distribution rulebook	The EU Good Distribution Practice (GDP) guide, binding in the EU	A PIC/S GDP guide since 2014, voluntary, for the authorities that inspect distribution
Who checks the inspector	Nothing outside the EU’s own joint audits	Assessment before joining, reassessment since 2000, one checklist, results accepted both ways
Training	Each authority trains its own inspectors	An annual seminar, joint visits, Expert Circles and, since 2016, an Inspectorates’ Academy
Pharmacovigilance	Each authority inspects pharmacovigilance under its own law	A mandate beyond GMP since 2023 and an Expert Circle on GVP that first met in 2025

Show the references

The rulebooks: PIC/S, GM(D)P Harmonisation; PIC/S, Publications (PE 009-18, PE 011-1).
Who checks the inspector: PIC/S, Compliance; PIC/S, Accession Procedure.
Training: PIC/S, Training; PIC/S, Benefits.
Pharmacovigilance: PIC/S, International Co-operation; PIC/S, Expert Circles; PIC/S home page, November 2025.

PIC/S binds no one. It makes 57 inspectorates provably alike, so that one visit can be trusted by the rest.

The facts, in one place

What it is	A non-binding, informal cooperative arrangement between regulatory authorities in GMP for human and veterinary medicines, open to any authority with a comparable inspection system.
Since	October 1970, the Pharmaceutical Inspection Convention of the European Free Trade Association, in force 1971; the scheme beside it since 2 November 1995.
Legal form	A Swiss association since 2004, registered in Geneva, with its own small Secretariat there since 1 January 2004.
Who decides	The PIC/S Committee of all Participating Authorities, one vote each, by consensus; an Executive Bureau of the chairs; seven Sub-Committees since 2014.
Members	57 Participating Authorities, Jordan’s the latest on 1 January 2026; the United States Food and Drug Administration since January 2011.
Documents	The GMP Guide (PE 009), the GDP Guide (PE 011), data management and integrity guidance (PI 041), quality system requirements for inspectorates (PI 002).
For safety	A mandate beyond GMP since 2023; Expert Circles on Good Pharmacovigilance Practices and Good Clinical Practices, first meeting November 2025.

Don’t confuse it with: a mutual recognition agreement

PIC/S

The network

Is: a voluntary arrangement between 57 inspectorates, with no legal obligation
Gives: one rulebook, shared training, assessed equivalence, shared reports and alerts
Example: an inspectorate spends three to six years earning membership

A mutual recognition agreement

The treaty

Is: a binding agreement between two parties to accept each other’s inspections
Gives: legal recognition of certificates; PIC/S membership may help conclude one
Example: the agreements between the EU and Switzerland, or Australia and Canada

Chapter 4

Test yourself

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

“PIC/S membership legally obliges every member to accept the others’ GMP certificates.”

MythTruth

MythYou got it.Not quite.

The scheme is non-binding: there is no legal obligation under PIC/S, and it is not a trade agreement. Membership builds the confidence that makes mutual recognition easier.

“Existing members are reassessed for equivalence, not only applicants.”