Regulatory Roundup: FDA and EMA Announce Joint Pilot Program
FDA and EMA Announce Joint Pilot Program
FDA and EMA announced on Mar. 16, 2011, that they would carry out a jointpilot program for parallel assessment of quality-by-design-based new drugapplications. The pilot applies to applications submitted to both agencies.According to a press release, the "parallel evaluation within this voluntarypilot program means that reviewers from both agencies will separately assessthe quality/chemistry, manufacturing and control (CMC) section of the newdrug applications (NDAs) submitted to the FDA and marketing authorizationapplications (MAAs) submitted to the EMA."
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.
