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BTS NRAS in the EMR

BTS NRAS in the EMR. Nabila E. Metwalli MD PhD metwallin@emro.who.int. BTS NRAs in the EMR. Process Started by QA Workshop in Blood & Plasma Establishments; EMRO, 2006 Followed by GMP Workshop in Blood & Plasma Establishments; Tehran, Iran, 2009

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BTS NRAS in the EMR

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  1. BTS NRAS in the EMR Nabila E. Metwalli MD PhD metwallin@emro.who.int

  2. BTS NRAs in the EMR • 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

  3. Why NRAs? • 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

  4. Situation in EMR • 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

  5. Situation in EMR (cont.) • 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

  6. Situation in EMR (cont.) • 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

  7. Who is Responsible for creation of NRAs? • Legislators (highest responsibility) • MOH • Inspectors from MOH if available • Directors of BTSs • QA officers in Blood & Plasma Establishments

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

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