1. Nabila E. Metwalli MD PhD metwallin@emro.who.int 1

2.  Process Started by QA Workshop in Blood & Plasma Establishments; EMRO, 2006  Followed by GMP Workshop in Blood & Plasma Establishments; Tehran, Iran, 2009  Now preparing for Training of Inspectors on GMP Workshop; 2013 2

3.  An autonomous body that regulates BTSs from both the system & technical sides  Absolutely necessary for Blood Safety  NRAs are usually a National body, preferably separate from MOH; as in Pharmaceutical & Vaccine NRAs 3

4.  Most member states have Guidelines & Policies, but lack Legislation or NRAs  Kingdoms of SAA & Jordan have developed FDAs, but currently involved in only pharmaceutical & vaccine regulation, with potential at expansion of their activities  Iran has a BTS Regulatory Authority 4

5.  Lack of NRAs causes availability of unsafe blood & blood products in about half the member states; both in the public & private sectors  Fragmentation of BTSs under different umbrellas: MOH, MOD, MOHE, Private sector, etc……. is a bad omen for Blood Safety 5

6.  Counter-fractionation is the method most used to produce Plasma-derived products in the region  NRAs with master files are the best choice for such procedures  This excludes GCC member states that import plasma derivatives in bulk procurements  Extremely under-developed countries use FFP in lieu of plasma derivatives, when available 6

7.  Legislators (highest responsibility)  MOH  Inspectors from MOH if available  Directors of BTSs  QA officers in Blood & Plasma Establishments 7

8. Don’t you wish you had an NRA for Blood & Plasma Establishments in your country? Thank you 8