US & EU Move to Strengthen Ingredients Supply Chain - Pharmaceutical Executive

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US & EU Move to Strengthen Ingredients Supply Chain
The US and EU move forward with measures to fortify the pharmaceutical supply chain.


PTSM: Pharmaceutical Technology Sourcing and Management


References
1. EMA, "Falsified Medicines," http://www.emaeuropa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8, accessed June 16, 2013.

2. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).

3. FDA, "FDA Obtains Waiver from European Commission to Facilitate Export for US Pharmaceutical Manufacturers," Press Release (June 21, 2013).

4. EMA, Good Distribution Practice of Medicinal Products for Human Use (London, March 2013).

5. EMA, "Key Deliverable of Falsified Medicines Directive Achieved," Press Release (Apr. 8, 2013).

6. FDA, "Food and Drug Administration Safety and Innovation Act Title VIIDrug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments," Fed. Regis. 78 (118) 36711-36715 (June 19, 2013).

7. FDA, Draft Guidance for Industry–Contract Manufacturing–Arrangements for Drugs: Quality Agreements (Rockville, MD, May 2013).

8. ICH, Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Geneva, 2000).

9. ICH, Q9 Qualified Risk Management (Geneva, 2005).

10. ICH, Q10 Pharmaceutical Quality Systems (Geneva, 2008).


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