Drugmakers Ask EMA to Provide Guidance, Harmonization And Flexibility For Advanced Therapies

To drive the development of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, harmonize EU regulations and exercise flexibility.

An agency report on advanced therapies noted several setbacks to advanced therapy development, pointing to a lack of specific guidance, incongruent EU requirements and inflexibility in licensing requirements as major roadblocks.

In the EU, only seven advanced medicinal products have received approval since 2009, prompting industry to make these requests during a stakeholder meeting in May. The EU defines advanced therapies as those comprising gene therapies, tissue engineered products and somatic cell therapies.