First Drug Approved Under New Scheme To Speed Access In Poorer Countries

Seven African Regulators Took Part In The Procedure

Switzerland’s medicines agency has cleared Ferring’s carbetocin for preventing uterine haemorrhage under the Marketing Authorization for Global Health Products (MAGHP) procedure, which is intended to accelerate the approval of new products in low- and middle-income countries. 

Africa_Map
Africa will benefit from a new drug approval scheme spearheaded by Switzerland • Source: Shutterstock

A new procedure for speeding access to essential medicines in low and middle income countries (LMICs) has produced its first fruit after the Swiss regulator issued a marketing authorization for a drug from Ferring used in the prevention of uterine haemorrhage.

Ferring described the approval as a landmark. The company will now submit its dossier to national regulatory authorities (NRAs) in...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

More from Geography

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By 

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.