EU, Australia to Collaborate on Orphan Medicines

The European Medicines Agency and Australia’s Therapeutic Goods Administration have signed an agreement allowing them to share full assessment reports of marketing authorization applications for orphan drugs.

Under the accord, the EMA and TGA can request completed reviews of an orphan drugmaker’s application without redaction of commercially confidential information, EMA spokeswoman Sophie Labbé told Drug Daily Bulletin Monday.

Each agency will still make its own decision whether to authorize a particular orphan product in their jurisdiction.

The agreement expands on earlier collaborations between the two. In 2012, the EMA, TGA and the FDA agreed to conduct joint GMP inspections of active pharmaceutical ingredient manufacturers. — Lena Freund

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