Five European health care trade groups say they support the implementation of an effective pharmacovigilance system to ensure patient safety and recognize recent efforts which have been made to ensure greater fairness, proportionality and transparency in some aspects of the proposals for the mechanism of fees to be paid to the European Medicines Agency for these Pharmacovigilance activities.
Notably, the industry welcomes the improvements regarding the annual fee to be paid by the Marketing Authorization Holders to the EMA, according to a joint statement by the European Federation of Pharmaceutical Industries and Associations (EFPIA), European Generic medicines Association (EGA), European biotech industry (EuropaBio), Association of the European Self-Medication Industry (AESGP), and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).
But concerned over increasing financial burden
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