EMA Recharges Role In Non-EU Drug Approvals
Agency Wants More Firms To Use ‘EU-Medicines4all’ Scheme
The EMA’s process for assessing medicines for use in non-EU countries is being beefed up after a review showed the mechanism had several flaws that made it unattractive to many companies.
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A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.
EMA Offers Simultaneous Review Of Products For EU And Non-EU Markets
Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.
UK Industry ‘Struggling’ With Skill Gaps In AI, Robotics & Data Analytics
A new report says that pharma firms are finding it difficult to recruit staff with experience in emerging scientific technologies, particularly in areas such as regulatory and quality assurance. COVID-19, Brexit and competition for talent with other countries and industry sectors are cited as key factors.