EMA: Scientific Advice, Fee Waivers, Faster Reviews Available for Export-Only Drugs

The EMA detailed the resources available for drugmakers seeking approvals of drugs that are intended for markets outside the European Union in a three-page guideline.

Since Article 58 — a regulation which allows the EMA and WHO to recommend export-only drug candidates — took more than a decade ago, the EMA has endorsed only seven drugs for approval, including GSK’s antiseptic gel Umbripro and Sanofi’s whopping cough vaccine Hexaxim.

To shepherd more approvals, the EMA reminds sponsors that they can schedule meetings to address issues related to development of a particular candidate and seek accelerated approvals for candidate targeting unmet needs. Small and medium-sized firms can also benefit from t financial, regulatory and administrative assistance.