Moderna Wants Changes To EU Proposals On Gene Therapy, Platform Technologies
The revamped EU pharma legislation must be able to deal with current and future innovations in areas such as platform technologies and genome editing, the US biotech firm says.
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On the back of a successful pilot of early consultations with patients, the European Medicines Agency is extending the initiative so that patient and health care professional groups can give valuable input in areas such as unmet needs, clinical trial endpoints and expectations for future treatments.
Building new local manufacturing facilities raises issues such as regulatory complexity, the supply of raw materials and what to do with “ever-warm” production sites outside health crisis situations, a conference heard this week.
An updated UK PharmaScan platform is to be delivered within the first three years of the new voluntary drug pricing scheme, with companies agreeing to provide “timely, accurate and comprehensive information” for all their medicines in development.