Monographs on ARV and hepatitis medicines in The International Pharmacopoeia
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1 Monographs on ARV and hepatitis medicines in The International Pharmacopoeia Technologies, Standards and Norms 1
2 The International Pharmacopoeia contains analytical methods and specifications for active pharmaceutical ingredients (API) finished pharmaceutical products radiopharmaceuticals focuses on medicines Model List of Essential Medicines Invitations to submit EOI for product evaluation to PQTm WHO/UN specific disease programmes 2
3 The International Pharmacopoeia main areas of work medicines for maternal, newborn, child and adolescent health antimalarial medicines antiviral medicines including antiretrovirals antituberculosis medicines medicines for tropical diseases part of WHO normative work based on the decision of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) 3
4 The International Pharmacopoeia applies current international standards comply with harmonized regulatory standards focus on technical aspects most relevant for developing countries Ph.Int. aims at global applicability of its methods/specifications for complex, technically demanding methods less sophisticated tests are given as an alternative, if equally satisfying rational use of International Chemical Reference substances (ICRS) in situ preparation of impurities for identification purposes quantification of impurities preferably by comparing their responses with the response of the parent compound in a diluted sample solution (together with the establishment of correction factors) 4
5 International Chemical Reference Substances (ICRS) primary reference standards established by European Directorate for the Quality of Medicines & HealthCare (EDQM) under the authority of WHO Expert Committee on Specifications for Pharmaceutical Preparations 5
6 Antiviral medicines including antiretrovirals 34 monographs on antiviral medicines Abacavir oral solution, Abacavir tablets, Aciclovir for injection, Aciclovir tablets, Atazanavir capsules, Didanosine oral powder, Didanosine tablets, Paediatric didanosine liquid for oral use, Efavirenz capsules, Efavirenz, emtricitabine and tenofovir tablets, Efavirenz oral solution, Efavirenz tablets, Emtricitabine and tenofovir tablets, Emtricitabine capsules, Indinavir capsules, Lamivudine oral solution, Lamivudine tablets, Lopinavir and ritonavir tablets, Nelfinavir mesilate oral powder, Nelfinavir mesilate tablets, Nevirapine oral suspension, Nevirapine tablets, Oseltamivir capsules, Ritonavir tablets, Saquinavir mesilate capsules, Saquinavir tablets, Stavudine capsules, Tenofovir tablets, Zidovudine and lamivudine tablets, Zidovudine capsules, Zidovudine intravenous infusion, Zidovudine, lamivudine and abacavir tablets, Zidovudine, lamivudine and nevirapine tablets, Zidovudine oral solution 6
7 Work Plan 2015/2016 the development of new monographs follows our priority setting procedures: monographs for essential medicines listed in EOI 12th Invitation HIV/AIDS, hepatitis B/C medicines (September 2014) that have not yet been subject to a monograph published by another major pharmacopoeia USP 38; IP 2014 (incl. Addendum 2015), BP 2015, CP 2010, JP 16 will be developed with HIGH PRIORITY result of the survey performed in antiviral medicines (incl. antiretrovirals) were identified for future elaboration with high priority 7
8 Work Plan 2015/2016 Monographs proposed for future elaboration ABACAVIR, EFAVIRENZ AND LAMIVUDINE TABLETS ABACAVIR, LAMIVUDINE AND NEVIRAPINE DISPERSIBLE TABLETS ATAZANAVIR AND RITONAVIR TABLETS DOLUTEGRAVIR TABLETS EFAVIRENZ, LAMIVUDINE AND TENOFOVIR TABLETS ENTECAVIR ORAL SOLUTION ENTECAVIR TABLETS RALTEGRAVIR TABLETS RIBAVIRIN SYRUP RITONAVIR ORAL SOLUTION SIMEPREVIR CAPSULE SOFOSBUVIR TABLETS TERIZIDONE CAPSULES TERIZIDONE TABLETS ETRAVIRINE TABLETS ZANAMIVIR POWDER FOR INHALATION LAMIVUDINE AND TENOFOVIR TABLETS 8
9 Benefits of Public Standards / Ph. Int. public standards facilitate the production, registration, quality control and procurement of medicines allow for an independent judgment on the quality of medicines easy reference to acceptable quality standards (specifications, test methods and reference substances) manufacturer has to demonstrate suitability of the tests regulatory authorities have to approve the specifications basis for regional/international harmonization represent reference tests in case of doubt or dispute applicable worldwide (The International Pharmacopoeia) 9
10 How to participate in the work of The International Pharmacopoeia? comments are welcome on monographs and general texts under public consultation already published monographs and general texts web site with our current projects: donations are welcome SRA approved test procedures and specifications product samples to verify test procedures to back up specifications candidate material to establish ICRS 10
11 Quality Assurance of Pharmaceuticals guidelines development production distribution inspection quality control other regulatory affaires 11
12 Thank you very much for your kind attention!
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