EMA, the European Medicines Agency, has reported that the Swiss Agency for Therapeutic Products (Swissmedic) is using the European Union’s EudraGMDP database to enter information on Good manufacturing practice (GMP) compliance, as well as on manufacturing authorisations related to Swiss manufacturers.
This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.
The EudraGMDP database is the EU’s database on manufacturing, import and wholesale-distribution authorisations, and GMP and Good distribution practice (GDP) certificates. A public version of the database has been available since 2011 and gives public access to the information in the database that is not commercially confidential or contains personal data.
Information about GMP compliance status of manufacturing facilities can be readily verified online by all stakeholders, including importers, manufacturers and regulatory authorities.
Mutual recognition agreement
This latest development is part of the mutual recognition agreement (MRA) between the EU and Switzerland, operational since June 2002 and most recently updated in August 2017.
The latest amendment introduced the provisions on data entry to EudraGMDP by the Swiss authorities.
Swissmedic has ‘read and write’ access to the database and will be entering GMP compliance information on Swiss manufacturers, including those exporting to the EU. As a consequence, the regulatory requirement to provide original paper GMP certificates issued by EU or Swiss authorities will be replaced by either the provision of a reference to an entry in EudraGMDP or by means of a downloadable file or printout from the database.
The details of the specific applicability of this measure depend on the respective regulatory procedures, e.g. as regards importation or marketing authorisation, and are clarified in relevant notices of each party.
In cases where a certificate of GMP compliance cannot be accessed via the EudraGMDP database, the document will have to be requested following the “traditional” procedures directly from the competent authority which inspected the manufacturer in question.
EMA offers 'read and write' access to EudraGMDP to the regulatory authorities of all countries with which the EU has an MRA.
Since 2013, the Japanese authorities also enter data into EudraGMDP which allows waiving the need for paper GMP certificates for certain procedures.