GMP and Pharmacopoeia: Harmonisation of Basic Regulators’ Tools Dr.-Ing. Stephan Roenninger Amgen (Europe) GmbH Director, External Affairs

Manufacturing Techniques and Regulatory Expectations for Medicines Have Increased over the Years - Harmonisation is Regarded Beneficial 1880 1970 2010 2020 Tomorrow ? 1405 1516 1866 1949 1970 1990 2010 Regulatory requirements

The Complexity of the Responsibilities Drive the Need for Collaboration Among Different Actors in the Regulatory System Ministry of Health III. GMP conference 2018 Opportunities to seek advice from other actors in the regulatory field Registration Russian Accreditation Service (Min. Economic Developm.) Ministry of Industry & Trade (MinPromTorg) Testing requirements Licensing of Manufacturing Certification Authorities & Testing labs (‚Notified body’) Federal Service of Surveillance of Healthcare Registration testing Pharmaceutical License Surveillance testing State Institute of Drugs and Good Practices (Notified Body) GMP Inspections E. Meyers, N. Parfenova, S. Rönninger, Manufacturers Face Certification, Licensing Steps in Russia, PDA letter, January, 2014, 38-41.

Awareness of Innovation and Modern Manufacturing Can Provide Input to Inspections Capability of the manufacturing process Adequacy of production & control procedures Suitability of equipment and facilities Effectiveness of the Quality Management System (QMS) Opportunities for continuous improvement on regulatory expectations Inspections

Potential Consequences: There is Overlap of Regulatory Oversight which Can put Additional Testing in Question Potential Consequences: Delayed Access Recall Shortage Resource hungry Registration . ? Level of additional detail* Registration testing ? GMP Inspections . ? Import testing ? Surveillance testing ? *(Analytical) Normative Document

Risk Based Approaches Can Help to Gain More Knowledge, When Relying on Inspections Performed by Recognized Inspectorates ? Risk-based inspection planning PIC/S guideline PI 037-1, 1 January 2012 GMP-Inspection reliance, PIC/S guideline PI 048-1, 1 June 2018 Classification of GMP Deficiencies, PIC/S guideline PI 040-1, 1 January 2019

Opportunity to better informed decisions Inspection Management Can be a Transparent Process Supporting Informed Regulatory Decision GMP certificate for sites Risk Management Inspection Share draft Report CAPA by the site Regulatory Decision Reliance, remote (desktop) review Duration & Focus Frequency – Reinspection Opportunity to better informed decisions Risk-based inspection planning PIC/S guideline PI 037-1, 1 January 2012 GMP-Inspection reliance, PIC/S guideline PI 048-1, 1 June 2018 Classification of GMP Deficiencies, PIC/S guideline PI 040-1, 1 January 2019 A Concept for Harmonized Reporting of Inspections, EFPIA, position paper, 29. May 2015 Consider alternatives to a follow up inspections performed by different inspectors, on the full program and length

Supposed Legal Barriers can Demonstrate Opportunities on Inspections and Import Testing when Taking a Different Perspective

Supposed Legal Barriers can Demonstrate Opportunities on Inspections and Import Testing when Taking a Different Perspective Ministry of Health Registration Russian Accreditation Service (Min. Economic Developm.) Ministry of Industry & Trade (MinPromTorg) Testing requirements Licensing of Manufacturing Certification Authorities & Testing labs (‚Notified body’) Federal Service of Surveillance of Healthcare For Patients Registration testing Pharmaceutical License Surveillance testing State Institute of Drugs and Good Practices (Notified Body) GMP Inspections Acknowledgement: Elisabeth Meyers, Paul Lucas