impact of the who website on the regulatory control of ... · 11/02/2010 1 impact of the who...

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

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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

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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

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Information to evaluate..

snake species –venoms horses: health care programme, vaccination, antibiotic usedimmunization programme

Hyperimmune plasma collection & storage, Potency titer …

Fractionation & purification processQC testing

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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)

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Thai snake antivenoms

- 2 SAV manufacturers:- 7 products (monovalent

antivenoms)

How these preparations are controlled in Thailand?

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WHO critical control functions

- GMP - Marketing authorization- Lot release

WHO, Thai Pharmacopoeia

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WHAT IF..???? ....have limit knowledge/ experience regarding snakes, venomsdo not familiar with SAV…

import the products with/without registration

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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

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WHO Guidelines

WHO Database: Medically Important Snakes Distribution maps, pictures & antivenoms

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Contents on website

Snake photo gallery – by regionsManufacturers – worldwide

Product listSnake giving venom

Unique website as a tool…

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In conclusion..

Not only the name on the label.. but also the content inside...

THANK YOU