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Regulatory

New procedures for filing post-authorisation variations published by EMA

The WHO approved the amendments to the International Health Regulations

The EMRN designated as a WHO Listed Authority

The EU Commission proposal for the revision of the Variations Regulation

Unitary SPC, the EU Parliament approved its position

New partners for Darwin EU

The creation of the African Medicines Agency

EMA-HMA and MHRA plans on artificial intelligence

The new FDA Digital Health Advisory Committee

ANAFAM associated to IGBA representing Mexico

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