1. Pink Sheet
  2. >>Geography
  3. >>Europe

Turkish Medicines Agency Moves Closer To ‘Reference Regulator’ Status

 
• By Ian Schofield

“Maturity level 3” signifies that Türkiye now has a “stable, well functioning and integrated” regulatory system.

waving colorful national flag of turkey on a gray map background
The Turkish medicines agency has improved its regulatory ranking • Source: Shutterstock

The World Health Organization has announced that the Turkish medicines agency has reached “maturity level 3” status following an assessment using the WHO’s Global Benchmarking Tool (GBT).

The move brings the Turkish agency closer to becoming a “WHO listed authority,” a scheme that began in March 2022 and “lists the

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
Start Free Trial

Already a subscriber?

More from Europe

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

More from Geography

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.