Swissmedic Begins Working With EudraGMDP Database
As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database.The European Medicines Agency (EMA) noted on Thursday that the Swissmedic entries apply to all new or renewed manufacturing authorizations and the related GMP-certificates issued using new templates, which are similar to those used by 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,” EMA said.
As far as Swissmedic’s access to the EudraGMDP database, it can read and write in 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 data base,” EMA said.
If a certificate of GMP compliance cannot be accessed via the EudraGMDP database, the document will have to be requested directly from the competent authority that conducted the inspection.
EMA also noted that it offers read and write access to EudraGMDP to all regulators from countries with which the EU has an MRA. For instance, since 2013, the Japanese regulators also began entering data into EudraGMDP, negating the need for paper GMP certificates in some cases.
EMA
Swissmedic Certificates
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