News about GMP/cGMP


GMP/GDP IWG Annual Report 2021

GMP/GDP IWG Annual Report 2021

On 19 April 2022, the EMA published the annual report of the GMP/GDP Inspectors Working Group for the year 2021. Both, Brexit and the COVID pandemic had resulted in no reports being issued for the last three years. Instead the EMA had published a Business Continuity Plan (BCP), which was primarily based on a prioritisation of tasks.

The GMP/GDP IWG provides input and recommendations at EU level on all issues directly or indirectly related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The working group also maintains a close exchange with international regulatory authorities.

Some interesting facts in brief:

  • GMP and GDP inspections
    The transitional measures introduced during the COVID pandemic, such as remote inspections and the automatic extension of the validity of EU GMP certificates in EudraGMDP, have been extended until the end of 2022, according to the annual report.
  • MRA with the USA
    Veterinary medicinal products are currently being included in the scope of the EU-US MRA.
  • MRA with Canada
    The CETA economic agreement has been provisionally in force since 2017 pending ratification by all EU member states with the addition of voluntary recognition of inspections by third countries. Mutual recognition of GMP inspections conducted outside the territory of the Parties was implemented in April 2021.
  • MRAs with Switzerland, Japan, Australia, Israel
    No changes were made.
  • Agreements with Great Britain
    The EU-UK trade agreement with the UK has been in force provisionally since 2021, as not all ratification processes have been completed yet. This also includes an annex on mutual recognition of inspection results.
  • GMP and GDP regulations
    - A concept paper on Annex 11 (computerised systems) and on Chapter 4 (documentation) are currently in preparation.
    - A revised Annex 1 draft on sterile manufacturing has been finalised and is expected to be adopted in 2022.
    - Annex 21 on the import of medicinal products was finalised for publication in early 2022.
    - A reflection paper on GMP and marketing authorisation holders was published.
    - A draft Annex 4 on the manufacture of veterinary medicinal products was submitted.
    - Guidance on the accountability of handling and shipping of investigational medicinal products for human use was finalised.
  • ICH and PIC/S
    The GMP/GDP working group is in close exchange with ICH and PIC/S with the aim of harmonising guidelines and procedures. This also includes collaboration on revision documents such as ICH Q9 or ICH Q14.


EMA: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021