EMA's GMP Plans for 2018

The European Medicines Agency (EMA) has published the 2018 Work Plan for the GMP/GDP Inspectors Working Group. The activities defined in the work plan take into account the preparation work load for the Agency's relocation to Amsterdam and might therefore be subject to changes and reprioritisations. However some new guidance and some revisions to existing requirements are planned (most of these are planned for the fourth quarter - Q4 2018). Here is an overview:

New Guidance

A final text for publication is planned for Annex 21 to the EU-GMP Guide (Importation of Medicinal Products).

A Reflection Paper on the Relationship between GMP Compliance and the Responsibilities and Activities of Marketing Authorisation Holders and Manufacturing Authorisation Holders should be finalised.

The Quality Working Party (QWP) Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container should be published in its final version.


The introduction of the EU-GMP Guide will be revised to reflect recent changes to the overall structure of EU-GMP guidance, including authorised products, IMPs, ATMPs and APIs.

EMA is also planning to revise Chapter 1 (Pharmaceutical Quality System) of the EU-GMP Guidelines. In the new document, risk-based approaches to prevent drug shortages will be included.

A revised Chapter 4 (Documentation) will consider data integrity references. This would be in parallel with similar amendments of Annex 11 (Computerised Systems).

After the public consultation phase, a final text for publication of Annex 1 (Manufacture of Sterile Medicinal Products) should be provided to the European Commission.

The Quality Working Party (QWP) Guideline on the Manufacture of the Finished Dosage Form should be released as a draft guideline for a six months consultation phase.

Other Guidance

Support of the EU members of the Expert Working Group (EWG) in developing the new ICH Q12 Guideline (Lifecycle Management) with a focus on GMP inspection and Pharmaceutical Quality System aspects.

Publication of Q&As on the implementation of the updated Shared Facilities Guidance.

Inspection Activities

Further use of information from international regulatory authorities to support risk-based approaches and to better use EU inspection resources.

Collaboration with PIC/S (Pharmaceutical Inspection Convention/Co-operation Scheme) and MRA (Mutual Recognition Agreement) partners in joint audits.

Development of contacts and collaboration in the field of GMP and GDP inspections with EU candidates.

Further development and improvements of the EudraGMDP database including the use of the database by MRA partners to replace the paper exchange of GMP certificates.

Source: EMA's Work plan for the GMP/GDP Inspectors Working Group for 2018

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