1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

Overhaul In Store For Cambodia's ‘Fragmented’ Drug Rules

 
• By Ian Schofield

Cambodia’s drug regulatory framework needs an overhaul, according to the World Health Organization, which has issued a tender for interested parties to review the current situation and produce draft legislation that meets current international norms.

Cambodia
Cambodia's drug regulatory framework needs updating • Source: Shutterstock

The World Health Organization says that Cambodia’s regulatory and legislative framework for pharmaceuticals and medical devices is to be brought into line with modern-day international standards because the existing rules are fragmented and enforcement of the legislation is “challenging.”

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 Approval Standards

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

More from Pathways & Standards

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

US FDA Commissioner Rejected Some Proposed Reorg Plans

 
• By Elizabeth Orr

FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.