Khartoum 68 December 2014 Dr Lembit Rägo Head Regulation of Medicines and other Health Technologies Essential Medicines and Health Products WHO Member State Mechanism Member State Mechanism Work Plan ID: 746131
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First Conference of Regulatory Authorities in Sudan and Neighbouring Countries
Khartoum, 6-8 December 2014
Dr Lembit Rägo
Head, Regulation of Medicines and other Health Technologies
Essential Medicines and Health ProductsSlide2
WHO Member State MechanismSlide3
Member State Mechanism – Work PlanSlide4
A Global Issue
Contaminated Active Pharmaceutical Ingredient (API) produced in one country
Exported to 6 other countries on three continents
Used to manufacture finished medicines
Caused loss of life and hospitalizations in two countries
International drug alerts issued, medicines and API seized Slide5
African Customs Seizure 2012Slide6
Rationale
PROTECT PUBLIC HEALTHSlide7
WHO Surveillance and Monitoring System ObjectivesSlide8
SSFFC Incidents Reported to WHO
9
0
Member States
trained in
9
workshops
250 Regulatory personnel
trained
18 large procurement agencies
trained
Over
530 Suspect Products
Reported
Incidents occurred in
65 countriesSlide9
West Africa 2012-14Slide10
Database High level Statistics
Over 530 medicines, vaccines and devices reported
285 (53%)
medical products reported are listed as WHO Essential Medicines
Over 50
reports refer to WHO PreQualified Medicines
10%
of reports involved attributable serious adverse reactions
8
WHO International Drug Alerts issuedSlide11
Suspect products reported by WHO Region Slide12
Therapeutic Categories by Suspect recordsSlide13
Falsified Antibiotics by APIfocus on amoxicillin distribution by regionSlide14
Patient HarmSlide15
CLASSIFICATION PRODUCT RECORDSSlide16
Criteria for WHO Medical Product Alert(Drug Alert)
Extended geographic
risk
Significant
threat to public
health
P
roduct in recent circulation
Validated Report
(
eg
. Lab analysis)Slide17
Global VulnerabilitiesSlide18
Prevention, Detection and ResponseSlide19
Collaboration is the key!
Thank you