Good Manufacturing Practice for Investigational Medicinal Products
Commission Delegated Regulation (EU) 2017/1569, of 23 May 2017, specifies the principles and guidelines of good manufacturing practice for investigational medicinal products for human use and the arrangements for inspections. It supplements the Clinical Trials Regulation (EU) 536/2014 and applies from the date that Regulation became applicable, 31 January 2022. Together with the Detailed Commission Guidelines on GMP for IMPs in EudraLex Volume 4, it replaced the former EU GMP Annex 13, which was repealed. It covers the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, QP release, outsourcing, and complaints and recall, alongside IMP-specific challenges such as blinding and comparators.
What this does not cover
stated in the document's own scope- It does not authorise or govern the conduct of the clinical trial itself; that is the Clinical Trials Regulation (EU) 536/2014.
- It does not cover certification and batch release of authorised commercial product, which follows EU GMP Annex 16.
- It does not restate general good clinical practice for trial conduct, which is addressed by ICH E6.
- The operational GMP detail is not in the Regulation itself but in the accompanying Detailed Commission Guidelines in EudraLex Volume 4.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EU) 2017/1569 sets the GMP baseline for medicines used in clinical trials — investigational medicinal products — in the European Union. Trial materials are made in small, changing quantities, are often blinded, and may include comparator products, so their manufacture raises issues that routine commercial GMP does not fully address. The Delegated Regulation states the GMP principles and the inspection arrangements for these products, and a companion set of Detailed Commission Guidelines in EudraLex Volume 4 gives the operational detail. Since 31 January 2022 this framework has replaced the former Annex 13, aligning IMP manufacture with the modern Clinical Trials Regulation.
Legal basis & how it acquires force
This is a Commission Delegated Regulation, directly applicable law in every EU member state without national transposition. It supplements the Clinical Trials Regulation (EU) 536/2014, which empowers the Commission to set GMP principles for investigational products, and it applies from the date that Regulation became applicable, 31 January 2022. On taking effect it, with the Detailed Commission Guidelines, replaced the former EU GMP Annex 13, which was repealed and removed from EudraLex Volume 4. Manufacturing IMPs requires an authorisation, and compliance is enforced by inspection.
Document structure
| Part | Covers |
|---|---|
| Subject matter and definitions | Scope over IMPs for human use and the terms used, referenced to the Clinical Trials Regulation |
| Pharmaceutical quality system | Quality management appropriate to investigational products and change control |
| Personnel and premises and equipment | Qualified staff and facilities suitable for IMP manufacture |
| Documentation and product specification file | Records supporting manufacture and release, including the product specification file |
| Production, quality control, and QP release | Manufacturing operations, testing, and certification of batches by the Qualified Person |
| Outsourcing, complaints, recall, and inspections | Contracted activities, handling of defects and returns, and the arrangements for GMP inspection |
Key requirements
- Operate a pharmaceutical quality system appropriate to the manufacture of investigational medicinal products.
- Ensure a Qualified Person certifies each IMP batch before release for use in a clinical trial.
- Maintain documentation, including the product specification file, that supports manufacture and release of each investigational product.
- Control production activities specific to IMPs, including blinding, randomisation coding, and management of comparator products.
- Apply quality control and reference and retention sampling appropriate to investigational products.
- Define and control outsourced activities through written agreements.
- Manage complaints, recalls, and the return and destruction of investigational product, preserving the blind where required.
Implementation tips
- Build the product specification file early, since it anchors both manufacture and QP release for the IMP.
- Handle comparator sourcing and any re-packaging with documented controls that preserve traceability to the original product.
- Design blinding and code-break arrangements so the blind holds in routine work yet can be broken safely when needed.
- Align the manufacturing and inspection arrangements with the clinical trial authorisation under the Clinical Trials Regulation.
International alignment
The Regulation applies across the EU and EEA and is read together with the Detailed Commission Guidelines on GMP for IMPs in EudraLex Volume 4 and with the good-clinical-practice framework of ICH E6, which governs the trials the products supply. It connects to the pharmaceutical quality system of ICH Q10 and to the QP certification principles that also underpin commercial release. It sits directly under the Clinical Trials Regulation (EU) 536/2014, which is the parent instrument.
Reg. (EU) 2017/1569: frequently asked questions
Quick answers to common questions about Reg. (EU) 2017/1569.
What did Regulation (EU) 2017/1569 replace?
Together with the Detailed Commission Guidelines on GMP for IMPs, it replaced the former EU GMP Annex 13, which was repealed and removed from EudraLex Volume 4.
When did it start to apply?
It applies from 31 January 2022, the date the Clinical Trials Regulation (EU) 536/2014 it supplements became applicable.
Is it a directive or a regulation?
It is a Commission Delegated Regulation — directly applicable law across the EU without national transposition — supplementing Regulation (EU) 536/2014.
Does a Qualified Person release investigational products?
Yes. A Qualified Person must certify each batch of an investigational medicinal product before it is released for use in a clinical trial.
Where is the operational GMP detail found?
The Regulation sets the principles; the detailed operational expectations are in the Detailed Commission Guidelines on GMP for IMPs in EudraLex Volume 4.