Regulatory in brief | EMA, stimulant laxatives, FDA

Regulatory in brief | EMA, stimulant laxatives, FDA

4 October 2021 - Deborah Wilkes

The European Medicines Agency (EMA) has a new head of international affairs, New Zealand is consulting on proposed warnings and advisory statements for stimulant laxatives, and the US Food and Drug Administration (FDA) has launched an OTC monographs online portal.

New head of international affairs for Europe’s EMA

The European Medicines Agency (EMA) has appointed Martin Harvey Allchurch as its new head of international affairs.

He replaces Agnès Saint-Raymond who has retired after 21 years.

Harvey Allchurch joined the EMA in 1995 and has held a number of positions including principal international affairs officer and head of communication. He has also worked for the global health initiative Unitaid.

New Zealand consults on stimulant laxatives

New Zealand is consulting on proposed warnings and advisory statements for stimulant laxatives.

The country’s medicines agency, Medsafe, said stimulant laxatives were either general sale or pharmacy-only medicines which meant there was no requirement to have a data sheet or consumer medicine information leaflet.

“Consumers may therefore be unaware of the harm associated with long-term use or overuse of stimulant laxatives when purchasing these medicines,” commented Medsafe.

The proposed statements include “Does not help with weight loss” and “Prolonged or excessive use can be harmful”.

The consultation on stimulant laxatives – including bisacodyl, glycerol, sennosides and sodium picosulfate – closes on 8 November 2021.

US FDA launches OTC monographs online portal

The US Food and Drug Administration (FDA) has launched an online portal for OTC monographs.

The regulatory agency said OTC Monographs@FDA provided a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs.

At the time this news story went to press, the FDA had published 11 OTC monographs.

Creation of the online portal follows legislation covering reform of the OTC monograph system in the US that was signed into law in 2020 as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (click here to read the News story).

Back to Industry News

Share this page: