1. 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

2. 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

3. Is quality of medicines still Globally a problem?
Facts
Diethylene glycol poisonings continue
Roche Viracept (nelfinavir) case
Heparin case …

4. 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 : 427)

5. Can we rely on essential medicines against TB? (2)
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
WHO study planned on the use and quality of TB medicines with
NDRAs in Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan

6. 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

7. Medicines and blood products/related bilologicals – QSM/EMP
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"

8. 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)

12. Biennial International Conference of Drug Regulatory Authorities (ICDRA) – forum for 100+ nations