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11/02/2010 1
Impact of the WHO websiteon the regulatory control
of snake antivenom
Wichuda JARIYAPANInstitute of Biological products
Dept. of Medical SciencesMinistry of Public Health, Thailand
14th ICDRA Singapore
11/02/2010 2
Definition of Biologicals (WHO) Biological sources
Crude, semi purified extracts or purified fractions of microbial, animal or human tissues
Produced by biological processesTraditional/ Recombinant DNA/ Other biological technologies
Complex molecular structureCannot be characterized by physicochemical criteria alone
Biological assay
11/02/2010 3
A - Collection of venoms
B – Horse ImmunizationProtocols
C – Starting material of animal derived sera
D – Fractionation &Purification process
POOR QUALITY AND POOR REGULATORY CONTROL: Technology in the public domain
11/02/2010 4
Information to evaluate..
snake species –venoms horses: health care programme, vaccination, antibiotic usedimmunization programme
Hyperimmune plasma collection & storage, Potency titer …
Fractionation & purification processQC testing
11/02/2010 5
WHO Website for snake antivenoms
ANIMAL DERIVED BLOOD PRODUCTS
WHO Guidelines on production, control and regulation of snake antivenom immunoglobulin
WHO Database: clinically important venomous snakes species and its worldwide geographical distribution together with antivenoms for treatment of snakebite envenoming
WHO website hosting both the Guidelines and database (maps, pictures, products, manufacturers)
11/02/2010 6
Thai snake antivenoms
- 2 SAV manufacturers:- 7 products (monovalent
antivenoms)
How these preparations are controlled in Thailand?
11/02/2010 7
WHO critical control functions
- GMP - Marketing authorization- Lot release
WHO, Thai Pharmacopoeia
11/02/2010 8
WHAT IF..???? ....have limit knowledge/ experience regarding snakes, venomsdo not familiar with SAV…
import the products with/without registration
11/02/2010 9
The challenges for regulatorsWhere to get the specific SAVWhat information we need: snake species, neutralizing efficacy,safety, clinical data, PMS etc.How to evaluate the information
11/02/2010 10
WHO Guidelines
WHO Database: Medically Important Snakes Distribution maps, pictures & antivenoms
11/02/2010 11
Contents on website
Snake photo gallery – by regionsManufacturers – worldwide
Product listSnake giving venom
Unique website as a tool…
11/02/2010 12
In conclusion..
Not only the name on the label.. but also the content inside...
THANK YOU