Outi Mäki-Ikola appointed as Vice-chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)

Fimea’s Co-ordinating Senior Medical Officer, Outi Mäki-Ikola (MD, Adjunct Professor), was elected vice-chair of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 15 October. The vice-chair has been elected for the next three-year term. 

Mäki-Ikola has extensive experience in the pharmaceutical sector, both from the industry and as a regulator. Among other positions, she has worked at the European Medicines Agency and Fimea as a CHMP member since 2012. As a CHMP member, she has been a rapporteur for numerous marketing authorisation applications. She has also been involved in e.g. building the multinational assessment team concept within the EU regulatory network and developing a concept to improve the consistency of CHMP decision making. Mäki-Ikola has also been involved e.g. in the preparation of regulatory incentive guidelines and their implementation. 

“It is a great honour that my colleagues from different EU Member States have shown me confidence and elected me for this position. This is a significant acknowledgement of my long-standing work in the CHMP,” says Mäki-Ikola. 

“My EMA background has made me deeply interested in regulatory topics, and I believe I can significantly influence their scientific and practical implementation. Developing these aspects to support more efficient and evidence-based decision-making is crucial for medicine users across the EU.”

Fimea is Finland’s nationwide and competent pharmaceutical regulatory authority in the European regulatory network. 

“One of our goals is to contribute and support significantly the EU-regulatory network. Holding the position of the CHMP Vice-chair supports this goal,” says Fimea’s Director General Eija Pelkonen. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) assesses applications for marketing authorisations for medicinal products in the centralised marketing authorisation process and gives recommendations on whether a medicinal product should be authorised. The CHMP consists of one member and an alternate appointed by each of the EU Member States (plus Iceland and Norway). In the Committee all EU-Member States have equal voting rights. 
 

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CHMP press release (EMA)