During the past decade, industry and regulators around the world have been heavily focused on addressing the daunting challenges of assuring the quality of medicines across an increasingly globalized supply chain.
The recognition of the dimensions of these challenges and the significant resource limitations of industry and regulators to address them has driven the search for collaborations that will: ● enhance the flow of information ● foster harmonization around best inspection practices and GMP standards ● allow resource sharing in carrying out the needed regulatory oversight, and ● enhance the quality and availability of medicines around the world.
The story below is divided into five parts that explore various dimensions of the progress that has been made in developing these collaborations and what industry and regulators are working to accomplish as the new decade begins. There was a flurry of activity in the international inspection arena in the latter part of 2019 as reflected in the story’s components:
PART I focuses on a two-year pilot program announced in mid-December involving increased cooperation among the US, Europe, Australia, Japan, Canada, and the World Health Organization (WHO) in the oversight of sterile medicine manufacturing. The collaboration will allow the respective regulatory authorities to share information on inspections of sterile drug manufacturers who are located outside the participating countries and to organize joint inspections for manufacturing sites of common interest.
PART II provides the FDA vantage point on the development, scope, purpose, implementation, and potential expansion of the US/EU inspection mutual recognition agreement (MRA). Under the MRA, which entered its full implementation phase in July, US and EU regulators are now able to share confidential information and rely on each other’s surveillance inspections of human medicine manufacturing and distribution operations conducted in their own territories. The MRA implementation work is continuing with a view to expanding its effective scope to veterinary medicines, human vaccines, and plasma-derived medicinal products, and to the foreign inspection and pre-approval realms.
PART III draws from the discussion at a US Congressional hearing in December at which strong light was shed on the challenges that FDA and other regulatory agencies face in meeting their global oversight responsibilities – and why collaboration is an important component in their ability to address them. The hearing focused on FDA’s foreign drug inspection program and the ways it has been evolving in response to industry globalization and changes in law, regulatory policy and programs, and quality management understanding. Reviewed were the number of agency inspections conducted, inspection staffing levels, and the challenges unique to foreign inspections.
PART IV shifts the vantage point on the global inspection landscape to that of a European regulator. Provided are insights on: ● the role and importance of MRAs ● the EU experience with various MRA partnerships ● the development of the US/EU MRA – its scope, implementation phases, and impact to industry and regulators, and ● other regulatory harmonization and confidence building initiatives.
PART V offers insights on the US/EU and global inspection challenges and collaboration opportunities provided by surveys conducted by the European Federation of Pharmaceutical Industry Associations (EFPIA) and the Asia Pacific Economic Cooperation (APEC). The EFPIA survey, conducted annually, gathers data regarding GMP/GDP inspection activities and trends in the research-based industry, with the goal of highlighting inspection redundancies and promoting reliance, collaboration, and a harmonized risk-based approach in line with the standards developed through the Pharmaceutical Inspection Cooperation Scheme (PIC/S). APEC’s recent survey assesses the progress among its 21 member countries in inspection/GMP regulatory convergence.