Drugs

FDA, EMA Working Together on Herbal/Botanical Drugs

A 9/25 joint FDA/European Medicines Agency (EMA) workshop on “Regulatory Perspectives on Herbal Medicinal/Botanical Drug Development” set the stage for future joint activities in the herbal/botanical space, despite regulatory differences in the ways in which the two jurisdictions approach the products. An interview in an FDA online post gives perspectives on the workshop from FDA Office of Policy, Legislation, and International Affairs senior policy advisor Marta Sokolowska and EMA chief medical officer Steffen Thirstrup, who led the workshop for their agencies.

The post describes the regulatory framework in each jurisdiction, highlighting the similarities and differences in approach.

Asked about the key takeaways, Thirstrup said that while there are different legal frameworks, “We have a lot of the same challenges independent of those different frameworks. The workshop was an opportunity for us to exchange our challenges and focus on how we potentially could work on moving forward. We also wanted to inform the public that there are currently frameworks in place to reassure that some products you buy in European pharmacies would have well-established efficacy and safety and there will be some quality control.”

Sokolowska said the workshop focused on the development of herbal medicine and botanical drugs and deliberately did not include food or dietary supplement frameworks. The workshop also did not address herbals or botanicals that have or could have abuse potential.

She also noted that consumers are “starving for information” about these products and the two agencies wanted to convey both the information that is known and the many knowledge gaps that exist in the botanical drug development space.

The two say FDA and EMA found potential topics on which they can continue to collaborate. They will next turn their attention specifically to batch-to-batch quality variation and drug and herbal interactions.

“Despite our different regulatory frameworks,” Sokolowska concluded, “we share the same goal: supporting botanical drug development while acknowledging existing data gaps. Harmonized research efforts can help close these gaps.”

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Steps Proposed to Modernize U.S. Clinical Studies

HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

Law Firm Provides Overview of Guide on Drug Use-Related Software

Device Specificity Does Not Establish Insufficient Controls: AdvaMed