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EMA Recharges Role In Non-EU Drug Approvals

Agency Wants More Firms To Use ‘EU-Medicines4all’ Scheme

 
• By Ian Schofield

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.

Malaria
Malaria is one disease targeted by the EMA's EU-Medicines4all program

The European Medicines Agency is working on ways to entice more pharmaceutical companies to use its “Article 58” procedure, an assessment mechanism that was introduced in 2004 to increase the availability of medicines in non-EU countries with fewer regulatory resources and high unmet medical needs.

Article 58 allows the EMA’s drug evaluation committee, the CHMP, to give a scientific opinion on a marketing authorization application...

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