Regulatory initiatives consolidate into IPRP

Two global regulatory initiatives – the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF) – have combined into a single body under the banner of the International Pharmaceutical Regulators Programme (IPRP). Having more than a year ago agreed to “develop options for future co-operation between the two initiatives” (Generics bulletin, 11 November 2016, page 10), the IGDRP and IPRF have recently agreed to consolidate, with a goal of holding the first face-to-face meeting of the IPRP’s management committee in June this year.

Two global regulatory initiatives – the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF) – have combined into a single body under the banner of the International Pharmaceutical Regulators Programme (IPRP). Having more than a year ago agreed to “develop options for future co-operation between the two initiatives” (Generics bulletin, 11 November 2016, page 10), the IGDRP and IPRF have recently agreed to consolidate, with a goal of holding the first face-to-face meeting of the IPRP’s management committee in June this year.

“Both sides agreed that by a consolidation of the two initiatives, efficiencies could be gained and synergies be created,” the bodies noted

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Regulation

US FDA Expands Surprise Foreign Inspections

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By 

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By 

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

More from Policy & Regulation

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By 

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By 

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.