Global Manufacturing Challenges Industry Regulators - The FDA is increasing foreign inspections and adopting new initiatives to ensure the quality of imported medicines. - BioPharm International

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Global Manufacturing Challenges Industry Regulators
The FDA is increasing foreign inspections and adopting new initiatives to ensure the quality of imported medicines.


BioPharm International


MORE COOPERATION

Because US officials cannot inspect every plant or check the high volume of drugs coming across US borders, the FDA seeks to collaborate more with regulatory counterparts to better use its resources and to avoid redundant oversight activities. A 2007 survey of 22 companies by the European Federation of Pharmaceutical Industries and Associations shows that regulators spent 3,000 man days and the industry more than 100,000 man days on foreign inspections, reported Genentech Senior Director John O'Connor at the DIA annual meeting in June. While most manufacturing sites experienced three or four inspections a year, a few companies reported requests for more than 25 site visits.

To reduce such duplicative efforts, the FDA is teaming up with the European Medicines Agency (EMEA) and Australia's Therapeutic Goods Administration to better coordinate foreign drug inspections. The three agencies will consult each other on inspection schedules and reports, initially for API manufacturers in China and India. The three agencies will review manufacturing facilities on each other's lists and agree on which agency should go in first, explained FDA Deputy Commissioner Murray Lumpkin. In certain cases, all three regulators may visit a certain plant together. If successful, the program could expand from APIs to drug products.

Sharing information on inspection findings also can help regulatory authorities avoid unnecessary inspections. The FDA has more than 70 cooperative arrangements with foreign counterparts that permit mutual access to inspection information. Some 30 confidentiality arrangements, moreover, permit the FDA to share actual inspection reports with certain regulators. Such information can support regulatory decisions on where best to target foreign inspection resources.

Third-party accreditation also can help agencies use limited resources more efficiently. The FDA seeks to accredit more government and independent entities as capable of verifying that certain operations or products comply with US safety and security standards.

Information sharing and joint inspection activities can make the foreign-inspection process more efficient and productive. But neither the FDA, the EMEA, nor other regulatory authorities are ceding the right to evaluate and make independent enforcement decisions regarding any drug product or facility. The hope is that joint inspection activities will breed confidence in the approaches and decisions of colleagues, explained EMEA Head of Inspections Emer Cooke at the DIA meeting in June. These collaborative activities could eventually lead to increased reliance on each other's inspections, Cooke suggested that "cooperation, not competition" is the key to success.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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