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Strengthening national drug regulatory capacity

Strengthening national drug regulatory capacity. Valerio Reggi 11 October 2007. The three key statements on DRAs:. health system counts on DRA for good, safe, and effective medicines, as well as fair rules and control on drug trade, information, and use

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Strengthening national drug regulatory capacity

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  1. Strengthening national drug regulatory capacity Valerio Reggi 11 October 2007

  2. The three key statements on DRAs: • health system counts on DRA for good, safe, and effective medicines, as well as fair rules and control on drug trade, information, and use • any strategy to improve anything in the pharmaceutical area involves DRA • any problem encountered in the pharmaceutical area has something to do with the DRA

  3. Drug regulation is a multi- faceted activity at the centre of complex interactions Government Experts Manufacturers Regulatory authority Prescribers Products Medicines Patients/Consumers Importers/Wholesalers/Retailers

  4. Drug regulation is a multi- faceted activity at the centre of complex interactions Government Experts Manufacturers Regulatory authority Prescribers Products Medicines Patients/Consumers Importers/Wholesalers/Retailers

  5. Drug regulation is a multi- faceted activity at the centre of complex interactions Government Experts Manufacturers Regulatory authority Prescribers Products Medicines Patients/Consumers Importers/Wholesalers/Retailers

  6. Drug regulation is a multi- faceted activity at the centre of complex interactions Government Experts Manufacturers Regulatory authority Prescribers Products Medicines Patients/Consumers Importers/Wholesalers/Retailers

  7. Drug regulation comprises all the legal, administrative & technical arrangements meant to ensure that: • all premises, persons & practices engaged in the development, manufacture, importation, exportation, wholesale, supply, dispensing & promotion of drugs comply with approved standards, norms, procedures and requirements • drug products are safe, effective and of acceptable quality • product information is unbiased, accurate and appropriate • drugs are available

  8. What is quality?

  9. 2000, Nepal: school children mass-treatment campaign • Locally procured albendazole • QC tested after treatment completed, result: failed • Campaign outcome: success Background

  10. Questions Wrong sample? Wrong test? Wrong results? Wrong children? Wrong worms?

  11. Answer

  12. Two locally-manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for de-worming children in Nepal since 1999 tested against originator product (GlaxoSmithKline-GSK). The study API content, disintegration and dissolution testing and a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections 1277 children examined before and 21 days after treatment

  13. Results

  14. Results

  15. goal of mass treatment campaigns is to reduce the overall burden of infection within a population • 6.8 million tablets of ABZ are procured every year in Nepal Results Extra COST COST (US$)

  16. … questions on the importance of certain criteria used for planning mass treatment campaigns with anthelminthic drugs. The extremely poor performance of Curex's ABZ in quality tests would lead to the conclusion that it is unsuitable for use in a campaign. Yet, it has shown a good degree of effectiveness that, although inferior to the other two drugs, challenges the relevance or reliability of quality testing, as currently done, as a major decision criterion for inclusion of a specific product in de-worming campaigns. Results

  17. What is quality? Quality is suitability for purpose! All three products are of acceptable quality then? Let's discuss

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