Nominated by: Voisin Consulting Life Sciences

Organisation in nomination: European Commission 

1996 saw the first legal/regulatory framework for medicinal products in the European Union.

GONAL-f from Serono Laboratories was the first product recommended for approval via a centralised procedure and published in the EU Journal on 26 January.  The landmark approval demonstrated the EU integrated system for Medicinal Products approval and review, leading to the European Union granting Marketing Authorisation based on the EMEA’s Committee for Medicinal Products for Human Use (CMPH) recommendation.

It was a notable approval as the product is primarily used to treat women with sub-fertility.

Today, this is now the European Medicines Agency (EMA), based in Amsterdam and currently headed by Emer Cooke, provides scientific advice to innovators, expedited pathways to marketing authorisation and ensures high standards for human and veterinary medicines. Seven EMA scientific committees provide scientific expertise for the regulation of medicines by drawing on a network of over 4500 European scientific experts and using resources of over 40 National Competent Authorities (NCAs) of EU Member states.

The EMA oversees products developed in specialised areas of medicine such as Advanced Therapy Medicinal Products (ATMP), rare diseases, herbal medicines and medicines for children.

References:

• Summary of Community Decisions on marketing authorizations in respect of medicinal products from 15 October 1995 to 15 January 1996
• EMA public stakeholder meeting on the approval, safety monitoring and
  impact of COVID-19 vaccines in the EU
• Emer Cook takes office as head of EMA
• European Medicines Agency official website

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