The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products or the mutual acceptance of GMP inspections. Some agreements contain a sectoral annex or additional information on the role of the Qualified Person or similar functions:
Australia, Canada, New Zealand, Switzerland (full MRA, except for pre-approval inspections and medicinal products derived from blood or blood plasma for or from Canada)
The MRA provides assurance that equivalent GMP standards are applied by the parties of the MRA and removes the need for additional inspection and re-control at import. Importers in the EU must still have a (EU) Qualified Person who is responsible to certify that each production batch meets its specification. This certification may be based on a batch certificate, signed by a person releasing the batch for sale or export at a manufacturing site in the MRA country. This responsible person is deemed to be similar to the EU Qualified Person function and will be able to join the EQPA as a full member. This Responsible Person (or equivalent) needs to be registered/ accepted by the local competent authority to become a regular member.
Japan (MRA with limited scope)
Similar to the MRAs with Australia, Canada, New Zealand and Switzerland, but not all products are covered. The person responsible for signing a batch certificate according to the MRA can become a regular member of the EQPA. This needs to be verified (e.g. job description).
Israel (ACAA, Agreement on Conformity Assessment and Acceptance of industrial products)
This agreement covers products for human and veterinary use (medicinal products, active pharmaceutical ingredients and excipients) and procedures related to good manufacturing practice (GMP) and recognise each other's certification of conformity of batches, without the need for re-testing at import.
Israel has implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU. The additional responsibilities of the qualified person respectively the responsible pharmacist remain in accordance with the provisions of the EU and Israeli national laws. The Israeli Responsible Pharmacist named in the Ministry of Health approval of “Manufacturer/ Importer” license may become a regular member of the EQPA.
USA
With the recognition of Slovakia on 11 July 2019, all EU member states are now part of the MRA (Mutual Recognition Agreement). The FDA was already recognised by the EU in 2017. The main objective was to mutually accept the respective GMP inspection systems and to reduce the number of foreign inspections. Another part that will provide relief is the elimination of additional full batch testing of human medicines imported from the USA. A QP can now refer to the release documentation and the decision of a US quality organisation for batch certification. However, in order to fully accept or adopt the test results, a few basic requirements must be met, which are also mentioned in Article 9 of the MRA document and the current Question and Answer document:
- Testing was carried out in the United States of America
- The product was manufactured in the United States
- Each batch comes with a batch certificate (in accordance with the WHO certification system)
- This batch certificate has been issued by the manufacturer and certifies that the product complies with the requirements of the marketing authorisation
- The batch certificate is signed by the person responsible for releasing the batch (in USA)
The Qualified Person (QP) must make sure in advance that these points are met.
It is also important to assess the effects on the marketing authorisation. It must be ensured that the tests carried out in the USA fully comply with the marketing authorisation in the EU (e.g. methods, limits, testing and releasing site, etc.) - a corresponding change control process is indispensable here.
In addition, existing Quality Agreements should be adapted and qualification steps for the testing site should be completed (incl. audit).
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