Regulators Adjust to Better Meet Pharma Market Needs
Christine M. V. Moore, PhD, Global Head and Executive Director, Merck & Co., led “Changes in the Regulatory Landscape,” an education session held 31 October during the 2017 ISPE Annual Meeting & Expo.
The first speaker, Ellen F. Morrison, Assistant Commissioner of Medical Products and Tobacco Operations, US Food and Drug Administration (FDA), delivered a presentation on realignment within the FDA’s Office of Regulatory Affairs.
Her presentation centered on a 3 1/2-year restructuring effort within the FDA to improve its structure. “Change isn't the easiest thing the government does,” she admitted, “and the traditional structure I started in was no longer the right one for the future.” That model, which was geographically aligned, saw employees working in more than one program, regardless of their field of expertise.
The impetus for the transformation began in 2013, when former FDA Commissioner Margaret Hamburg wrote a memo that articulated the need for change: “Modernize and strengthen the FDA workforce to improve public health response in a way that keeps pace with acceleration of scientific innovation, global expansion of markets, and the modern legal authorities.”
“We believed we needed to be much more specialized, and so created a program-aligned organizational model, where each program specializes in a specific commodity,” said Morrison. This model, she continued, will harness technical expertise within the agency and allow a more uniform application of its policies and processes.
Morrison summarized the key changes: moving from geographic to program management of operations; changing regional food and drug inspectors to program directors; adding degrees of specialization to allow investigations, compliance, and operational managers to focus on one program; and consolidating 13 regional labs into national lab management. She also described the organizational structures of each of the offices in the Office of the Associate Commissioner for Regulatory Affairs.
“The benefits of realignment are many,” said Morrison, “not the least of which is that specialization by FDA-regulated product type more closely mirrors the organizational model in the industries that we regulate.”
Moore introduced the second speaker, Vladimir Orlov, Deputy Head of Educational Centre for Good Practices, State Institute of Drugs and Good Practices, of the Russian Federation. “It is unusual to have a member of the Russian Health Authority,” she said, adding that ISPE is working closely with Russia (to create an affiliate), and that these interactions will continue to grow.
Orlov provided an overview of the Russian regulatory system for drug manufacturing, and began by naming and describing four key bodies: Ministry of Healthcare, Federal Service for Surveillance in Healthcare, Ministry of Industry and Trade, and Federal Service for Veterinary and Phytosanitary Surveillance.
“The first inspections of foreign manufacturing sites were conducted only in April 2016,” said Orlov. “It took time to submit an application from the manufacturers, approve the inspection schedule, and carry out all necessary preparation measures.”
Priorities at the Ministry of Industry and Trade, said Orlov, include improving the system for state control over the conformity of medicine production, forming the branch system of advanced training and retraining of personnel in pharmaceutical production, and increasing the safety, efficiency, and availability of medicines for the Russian population.
In future, the ministry intends to “improve the regulatory and legal acts of the Russian Federation toward harmonization with the regulatory and legal acts of the EAEC (Eurasian Economic Community) and international standards; obtain the status of PIC/S applicant; establish an ISPE branch for the EAEC and CIS (Commonwealth of Independent States); establish partnerships with inspectors from other countries; and cooperate with BRICS countries (Brazil, Russia, India, China, and South Africa).”
The ISPE Annual Meeting & Expo brings together key international thought leaders for our biggest event of the year. Register for four days of world-class education, as we explore our 2018 theme: Vision to Reality: Delivering Next Generation Therapies.
