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Canada Considers Joining FDA-EMA Complex Generic Advice Scheme, But Is It Working?

FDA And EMA Share Their Thoughts On PSA Pilot Progress So Far

 
• By Urtė Fultinavičiūtė

Health Canada is open to the collaborative effort but is still in “preliminary discussions,” while the FDA and EMA try to attract more applicants to the parallel scientific advice pilot scheme for complex generics.

Businessman thinking on an arrow path.
• Source: Shutterstock

Health Canada is eyeing the possibility of joining the parallel scientific advice pilot for complex generics launched by the US Food and Drug Administration and European Medicines Agency, hinted Scott Appleton, manager of the division of Biopharmaceutics Evaluation at Health Canada.

During the recent FDA webinar “Expanding Generic Drug Access Through International Engagements,” Appleton said Health Canada was having preliminary discussions and

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