Update from FDA Office of Regulatory Affairs

Transcription

1 Update from FDA Office of Regulatory Affairs Ellen F. Morrison Assistant Commissioner for Medical Products and Tobacco Operations Office of Regulatory Affairs U.S. Food and Drug Administration 1

2 The Impact of Globalization on FDA s Mission Foreign production of FDA regulated goods and materials has exploded over the last decade. FDA regulated products originate from more than countries - 130,000 importers - 300,000 foreign facilities The number of FDA regulated shipments at 300 U.S. ports has more than doubled during the last ten years. - In 2006, approximately 15 million shipments of imported food and medical products crossed our borders. In 2015, it was 34 million. 2

3 and more Drugs and Devices - Today, about 35% of medical devices Americans use are made overseas. - And approximately 80% of the manufacturers of active pharmaceutical ingredients (API) used in the U.S. are located abroad. Food - Approximately 15% of food consumed by U.S. households is imported - Approximately 50% of fresh fruits and 25% of fresh vegetables consumed by U.S. households are imported - Approximately 85% of seafood eaten domestically comes from outside the U.S. 3

4 The Global Drug Manufacturing Supply Chain Ingredients Imported Finished Drug Ingredients Manufacture of Finished Drug Ingredients Active (API) Illustration of drug manufacturing supply chain: A U.S. finished drug may be produced using an active pharmaceutical ingredient (API) made in China and ingredients made in Europe, Japan, or the U.S. These components may shipped to India where the finished drug is manufactured and then imported into the U.S. for distribution. 4

5 FDA s Global Engagement FDA conducted more than 16,149 domestic inspections in FY That amounts to roughly 1,345 inspections a month or 60 inspections each day of the week. Our 650 laboratory analysts reviewed approximately 33,600 samples in FY 2015, more than 90 each day of the year. In FY 2015, Office of Criminal Investigations cases resulted in 348 arrests, 305 convictions, and more than $1.2 billion yes, billion in fines, restitutions, asset seizures and forfeitures. Overseas, our personnel conducted 3,512 inspections in FY 2016, in locations ranging from China to Chile to India. But in today s increasingly global environment, we can t do it all. 5

6 Advancing a 21st Century Approach to Global Drug Inspections 6

7 FDA Registered Drug Facilities ,877 FACILITIES 1,042 FACILITIES 454 FACILITIES United States European Union 435 FACILITIES China India 7

8 FDA Registered Drug Facilities % United States European Union 16% 55% China 63% India 8

9 FDA Inspections Throughout the World European Union China India Rest of the World 9

10 FDA Inspections In The European Union In 2016, there were 1246 drug facilities in EU FDA inspected 26% of the drug facilities in EU 6% of inspected facilities in EU led to an Official Action Indicated classification KEY = ~ 25 Drug Facilities = Facility inspected in

11 FDA Inspections In China In 2016, there were 740 drug facilities in China FDA inspected 17% of the drug facilities in China 20% of inspected facilities in China led to an Official Action Indicated classification KEY = ~ 25 Drug Facilities = Facility inspected in

12 FDA Inspections In India In 2016, there were 678 drug facilities in India FDA inspected 29% of the drug facilities in India 21% of inspected facilities in India led to an Official Action Indicated classification KEY = ~ 25 Drug Facilities = Facility inspected in

13 What is FDA Finding? Product filters for API manufacturing Tianjin, China Centrifugation Trying to re-create records Mumbai, 2016 for API manufacturing Records Tianjin, India retention China room 2014 Mumbai, 2016 India

14 FDA Inspection Outcomes: Import Alerts Issued EUROPEAN UNION 13% CHINA 29% OTHER COUNTRIES 27% INDIA 31% 14

15 FDA s Relationship with the European Union Harmonization and Standard Setting - International Council for Harmonisation (ICH) leaders - Scientific Advice/Parallel Scientific Advice Interactions for medicines of human and veterinary use - Quality by Design pilot Confidence Building - Active Pharmaceutical Ingredients inspection program - Good Clinical Practices/Bioequivalence inspection collaboration Mutual Reliance Agreement (MRA) Signed March 2,

16 MRA: Scope 16

17 MRA: Capability Assessment CONFLICT OF INTEREST (COI) EVALUATION FDA evaluates the Inspectorate s COI policies against European Medicines Agency (EMA) and FDA s own ethics regulations. JOINT ASSESSMENT PROGRAM (JAP) AUDIT OBSERVATION FDA experts observe an EU audit of a member state, including a pharmaceutical inspection conducted by the auditee s Inspectorate. PRIMARY ASSESSMENT FDA experts from various offices within FDA review the final EU audit report, the observers reports, the inspections reports, and other supporting documentation. SECONDARY ASSESSMENT Representatives of FDA s senior leadership assess the primary team s conclusions and make the final capability determination. 17

18 MRA: Key Agreement Points All Member States are included FDA will assess individual Inspectorates and recognize their inspection reports after FDA finds them capable with a satisfactory COI policy in place. FDA and EU will individually rely on the facts obtained from inspections to make their own enforcement decisions. JAP audits will be performed every 5-6 years and FDA will observe. All parties may request that an Inspectorate perform an inspection of a facility within their domain. EU and FDA reserve the right to perform GMP inspections in the other s domain as need dictates. 18

19 MRA: Benefits Stronger drug inspection expertise Greater efficiency Decreased duplicate inspections Reallocation of resources to areas with a higher public health risk 19

20 Unified FDA-EU Inspectorates CHINA INDIA KEY = Facility inspected in 2015 = Theoretical coverage post-mra 20

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