nabila e. metwalli md phd [email protected] 1
TRANSCRIPT
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