EMA Seeks Public Consult on Bioequivalence Concept Paper
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
The European Medicines Agency has released its draft concept paper on the development of product-specific guidance on demonstration of bioequivalence. Public comments are open until September 30.
EMA plans to develop product-specific guidance to enable a consistent approach to the assessment of applications based on bioequivalence data across various submission routes to help companies design study programs that meet European Union regulations. The guidance will be based on EMA’s guideline on the investigation of bioequivalence.
Source:
European Medicines Agency
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
