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Quality of Medicines: Introduction Tuesday, 17 November 2009

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 ragol@who.int.

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Quality of Medicines: Introduction Tuesday, 17 November 2009

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  1. Quality of Medicines:IntroductionTuesday, 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 ragol@who.int

  2. The MillenniumDevelopment 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 23.8.2008: 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. 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)

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

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