International GMP Regulators and PIC/S
Most major medicine regulators inspect to a common GMP standard, largely because of PIC/S, the Pharmaceutical Inspection Co-operation Scheme. PIC/S is a non-binding cooperative arrangement between inspectorates that maintains a GMP Guide aligned with the EU’s, writes recommendation documents for inspectors, and trains them. What PIC/S does not do is make national law the same: each authority’s legal text still decides who releases a batch to the market, what licences are needed and how long records must be kept. A company supplying several markets works to the harmonised standard and to each country’s legal differences.
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What PIC/S Is
PIC/S was established in 1995 as an extension of the Pharmaceutical Inspection Convention of 1970. It describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicinal products for human or veterinary use, open to any authority that has a comparable GMP inspection system.
Its aims are to harmonise inspection procedures worldwide by developing common GMP standards, to provide training for inspectors, and to build cooperation and networking between authorities and with regional and international organisations, increasing mutual confidence.
Who Participates
Participating authorities come from Europe, Africa, the Americas, Asia and Australasia. Accession dates on the PIC/S members list show how membership has grown: Swissmedic in February 1996, Health Canada in January 1999, the UK MHRA in June 1999, the US FDA in January 2011, Japan’s MHLW in July 2014, the Thai FDA in August 2016, Mexico’s COFEPRIS and Türkiye’s medicines agency in January 2018, Brazil’s ANVISA in January 2021, and the Saudi Food and Drug Authority and Bulgarian Drug Agency in July 2023.
Some countries are represented by one authority on behalf of several: Germany’s federal ministry and the central authority of the Länder count as one participating authority, and ANVISA represents Brazil’s state health surveillance bodies.
The PIC/S GMP Guide and Recommendations
The PIC/S Guide to GMP, the PE 009 series, is kept aligned with the EU GMP Guide. Revisions are timed together: PE 009-18, with a revised Annex 19 on reference and retention samples, entered into force on 24 September 2026, coinciding with the revised EU Annex 19 that the Commission published on 23 June 2026.
PIC/S also publishes PI recommendation documents that explain how to apply the Guide, written as training resources for inspectors and industry. PI 006-4 on qualification and validation, for example, entered into force on 1 October 2026 and supports Annex 15. Drafts can be joint: the EU’s draft Annex 22 on artificial intelligence was released jointly with PIC/S in July 2025.
Where National Law Still Differs
Harmonised GMP does not mean harmonised law. In Canada, GMP is a set of regulation sections in Part C, Division 2 of the Food and Drug Regulations, and the person in charge of each licensee’s quality control department approves each lot for sale; records are kept for one year after the drug’s expiry unless the licence says otherwise. In Japan, the marketing authorisation holder carries quality assurance duties under the GQP ordinance, including the market release decision, separately from the manufacturing-site GMP ordinance. In Thailand, separate licences cover manufacture, import and sale, and the overseas site of an imported drug must receive GMP Clearance before the product can be registered.
In the EU, GMP for human medicines rests on Commission Directive (EU) 2017/1572, with EudraLex Volume 4 giving the detailed guidance, and veterinary GMP now has its own implementing regulations. In the US, drug GMP is set by 21 CFR Parts 210 and 211. A plant supplying several of these markets meets the common GMP standard once, then adds each market’s release, licensing and record-retention requirements.
Common Dossiers, Separate Decisions
The same pattern holds for marketing applications. ICH M4 defines the Common Technical Document, in which Modules 2 to 5 are intended to be common to all regions and Module 1 is regional. A company can build one core dossier, but each authority still assesses and decides on its own.
PIC/S participation is not mutual recognition. Recognition of another authority’s inspections depends on separate agreements or national reliance policies; PIC/S builds the common standard and the mutual confidence on which such arrangements can rest.
FREQUENTLY ASKED
Is the US FDA a member of PIC/S?
Yes. The PIC/S members list shows the US FDA’s accession to the PIC/S Scheme in January 2011.
Does PIC/S membership mean authorities accept each other’s inspections?
Not by itself. PIC/S describes itself as a non-binding, informal co-operative arrangement. It harmonises GMP standards and training and builds mutual confidence; recognition of other authorities’ inspections depends on separate agreements or national reliance policies.
Is the PIC/S GMP Guide the same as the EU GMP Guide?
It is kept aligned with it, and revisions are timed together. PE 009-18 and its revised Annex 19 entered into force on 24 September 2026, coinciding with the EU’s revised Annex 19.
Who decides that a batch can be released in different countries?
National law. In Canada it is the person in charge of the licensee’s quality control department; in Japan the marketing authorisation holder controls market release under the GQP ordinance; in the EU it is the qualified person. The GMP standard is shared; the release role is not.
The inspection-readiness playbook for this topic
PUT THIS PLAYBOOK TO WORK
- HOW-TO GUIDEHow to Run One Site for Several GMP Regulators →Meet the shared GMP standard once and each market’s legal differences on top, so any of the site’s regulators can inspect it on any day.
- TEMPLATEInspection Readiness Plan →
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