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By Nagesh Bandi, Sharmista Chatterjee, and Dolores Hernán

Multinational pharmaceutical companies generally manufacture the same product, the same way for every market, region, and patient around the world. However, varying global regulatory expectations and review times can ultimately lead to the introduction of medicines into various regions at different points in time.

At the 2015 AAPS Annual Meeting and Exposition on October 26, the AAPS Regulatory Sciences section will present the symposium International Harmonization for Global Assurance on Quality. The symposium will be co-moderated by Nagesh Bandi (Pfizer) and Dolores Hernán (EMA). The objectives of this symposium are to:

  • discuss the industry and agency (Food and Drug Administration [FDA] / European Medicines Agency [EMA]) experience with the joint QbD pilot;
  • discuss the industry and agency (FDA/EMA) experience with joint inspections; and
  • discuss strategies how the joint EMA/FDA pilot program may improve global harmonization.

John Groskoph (Pfizer) will provide industry perspective on the pilot and touch upon opportunities for harmonization; Sharmista Chatterjee will share FDA perspective on the joint pilot; and Ann Marie Montemurro will provide an FDA perspective on joint inspections.

This symposium is an important forum for scientists from both innovator and generic drug companies to learn about the challenges in meeting varying global regulatory expectations and the ongoing efforts between the two regulatory agencies to harmonize regulatory expectations related to review and inspections. Such challenges to be discussed in this symposium are relevant global registration of pharmaceuticals and biopharmaceuticals. The EMA/FDA quality-by-design (QbD) pilot offers an opportunity to align United States and European Union regulatory approaches regarding implementation of various QbD concepts using actual applications.

This unique opportunity to hear from and interact with regulators from the United States and European Union is timely in aiding drug developers to understand the expectations in requirement among these major jurisdictions. Such understanding of global requirements can pave the path for possible harmonization for multinational drug companies. Some of the advantages offered by international harmonization include: opportunities for simultaneous global development and filing; joint review of marketing applications; improved post-approval change implementation; reduced supply chain complexity and drug shortages; and most importantly, increased patient access to medicines.

Nagesh Bandi, Ph.D., is the director of the New Products-CMC group at Pfizer Global R&D. He is currently the chair of the AAPS Regulatory Sciences Section and an associate editor for the newly-formed AAPS Open Journal.
Sharmista Chatterjee, Ph.D., is the division director (acting) in the Office of Process and Facilities (OPF). She is the chair-elect of the AAPS-MSE section and a member of numerous regulatory working groups.
Dolores Hernán, Ph.D., works as quality specialist in the Quality Office at the European Medicines Agency (EMA), London. She is a member of the Innovation Task Force on Nanotechnology and the scientific secretariat of the PAT team and the Quality Working Party Core Team.