Expanding global access to complex generics

Experts available for interviews to discuss findings from a six-country multi-region study

September 10, 2024

Rockville, MD-Innovators increasingly focus their drug development efforts on a distinct type of product identified by the U.S. Food and Drug Administration (FDA) as complex products. Similar products are recognized by the European Medicines Agency (EMA) under the category of hybrid medicines. These products present significant challenges for the development of generic versions, referred to as complex generics. The FDA publishes Product Specific Guidance (PSGs) to support developers of complex generics. However, regulators in many other countries do not recognize complex products as a distinct category of medicine and lack specific regulations to support their development.

A session at RAPS Convergence 2024 -the Regulatory Affairs Professionals Society Convergence, the largest and most recognized annual gathering of global regulatory affairs professionals-this month will feature presenters from EMA, FDA, and US Pharmacopeia (USP). Panelists will discuss international regulatory approaches for complex generics, the importance of expanding global access to these products, and how regulatory convergence can support this effort. Media representatives are invited to register or contact us for interview opportunities with USP panelists.

The panel session will address the findings of a six-country multi-region study that evaluated U.S.-approved products that were the subject of FDA-developed PSGs. The study's findings show how FDA's regulatory approach helps advance these products to approval in the U.S. and unveils the benefits that convergence may provide.

Key Findings from the study:

• In the U.S., 75% of complex generics identified were approved after the publication of PSGs.
• A higher number of complex generics are approved in the U.S. compared to most other countries.
• In the U.S., the lag between innovation and generic approval is shorter for many products compared to other regions.

Event Details:

• Date: September 19, 2924
• Time: 3: 15- 4:15
• Location: Room 201, Long Beach Convention & Entertainment Center, 300 E Ocean Boulevard, Long Beach, CA 90802 
• Presenters: Chaitanya K. Koduri, International Government & Regulatory Director, United States Pharmacopeia; Kevin V. Blake, Senior Scientific Specialist, European Medicine Agency, Netherlands; Sarah Ibrahim, Associate Office Director, FDA/CDER/OGD; Victor S. Pribluda, PhD, Senior International Regulatory Intelligence Manager, United States Pharmacopeia.

Media Contact:  
Nazila Fathi (she/her)
Email: [email protected]
US: +1-301-816-8547

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