nabila e. metwalli md phd metwallin@emro.who.int 1

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