quality of medicines: introduction tuesday, 17 november 2009
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Quality of Medicines: Introduction Tuesday, 17 November 2009. Dr Lembit Rägo, Coordinator Quality Assurance and Safety: Medicines (QSM), Department of Essential Medicines and Pharmaceutical Policies (EMP) World Health Organization Geneva, Switzerland [email protected]. - PowerPoint PPT PresentationTRANSCRIPT
Quality of Medicines:Introduction
Tuesday, 17 November 2009
Dr Lembit Rägo, CoordinatorQuality Assurance and Safety: Medicines (QSM), Department of Essential Medicines and Pharmaceutical Policies (EMP)World Health OrganizationGeneva, [email protected]
The Millennium Development Goals (MDGs) are eight international development goals that 192 United Nations member states and at least 23 international organizations have agreed to achieve by the year 2015
Is quality of medicines still Globally a problem?
Facts• Diethylene glycol poisonings continue• Roche Viracept (nelfinavir) case• Heparin case• …
Can we rely on essential medicines against TB? (1)
2008: South-Africa Drug Regulatory Authority withdraws from the market two FDCs (Pyrazinamide-Ethambutol-INH-Rifampicin and INH-Rifampicin) produced in India.
"Substandard tuberculosis medicines are particularly worth highlighting: there is little point in deciding optimum treatment regimens for TB when the medicines the patients actually use are not curative and/or encourage the spread of drug resistance" Paul Newton (BMJ 23.8.2008: 427)
Quality defects found in: Botswana: 4/13 FDCs Nigeria: 4/4 INH, 3/3 Pyr, 5/15 Rif and 10/19 Strep inj India: Amikacin, Etham (2x), Rif (2x), INH (2x), Pyr Myanmar: Rifampicin Hong Kong, Pakistan, Germany: Ofloxacin Rifampicin: Poor bioavailability in FDCs and
monotherapy
Can we rely on essential medicines against TB? (2)
WHO study planned on the use and quality of TB medicines with NDRAs in Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan
Quality failures
The Daily Star, 2008-11-19
Drug marketed to cure or kill?
Foreign particle, circled, is seen in a 500mg ampoule of Amibac (amikacin) intravenous injection. Photo: STAR
Who in WHO are dealing with quality, safety, efficacy and regulatory issues of medicines?
Medicines and blood products/related bilologicals – QSM/EMP
Vaccines and other biologicals – QSS/IVB … some other "pockets"
Quality Assurance and Safety: Medicines (QSM) team
One team, 7 inter-related programmes• Quality Assurance (Dr Sabine Kopp)• International Nonproprietary Names (Dr Raffaella
Balocco)• Quality Assurance of Blood Products and
Realated Biologicals (Dr Ana Padilla)• Safety (Pharmacovigilance) (Dr Mary Couper)• Regulatory Support (Dr Samvel Azatyan)• Anticounterfeiting (Dr Sabine Kopp)• Prequalification of medicines (Dr Anthony Gould)
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2006 2007 2008 2009 (I-IX)
Trainings organized or supported by PQP
PQP supported
PQP organized
Biennial International Conference of Drug Regulatory Authorities (ICDRA) – forum for 100+ nations