Prequalification of medications for need ailments

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. HIV/AIDS Crisis. Interest for moderate antiretrovirals is expanding. Various non specific makers offering items. Challenges for UN family and acquisition offices/associations. Which approach to go to get the most ideal insurance of general wellbeing with the assets accessible? . WHO/HTP/EDM/QSM.

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Prequalification of medications for need ailments EDM Technical Briefing March 2004 Dr Lembit Rägo Coordinator Quality Assurance and Safety: Medicines Essential Drugs and Medicines Policy Health Technology and Pharmaceuticals Cluster World Health Organization

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HIV/AIDS Crisis. Interest for moderate antiretrovirals is expanding. Various non specific makers offering items. Challenges for UN family and acquirement offices/associations Which approach to go to get the most ideal security of general wellbeing with the assets accessible?

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WHO/HTP/EDM/QSM Pre-capability What is the issue? Sub-standard medications bought powerless or truant quality affirmation frameworks Lot of cash put resources into acquisition no orchestrated quality confirmation framework accessible for obtainment associations/activities Duplication of work absence of blended benchmarks (GMP investigations) Risk: Sourcing sub-standard medications, misuse of cash and, wellbeing dangers to patients he from:

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Joint venture with other UN associations Prequalification of HIV/AIDS Drugs - UN joint movement Partners* UNAIDS UNICEF UNFPA WHO With the support of World Bank * All associations are additionally individuals from the International Pharmaceutical Co-appointment Group (IPC) m : WHO part Technical help in light of WHO standards and measures, in addition to ICH and different gauges, where relevant

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Procurement, Quality and Sourcing Project The prequalification part of the venture has two noteworthy exercises: nations are giving mastery I. Appraisal of items dossiers i.e. quality particulars, pharmaceutical advancement, bioequivalence and so on : groups of experts from national medication administrative specialists: Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Indonesia, Malaysia, Philippines, Spain, South-Africa, Sweden, Switzerland, Tanzania, Zimbabwe ... II. Fabricating website examinations: cooperation of reviewers: WHO agent (qualified GMP controller), assessor from entrenched inspectorate (Pharmaceutical Inspection Convention Scheme nations) and national inspector(s): Canada, France, Italy, Switzerland, The Netherlands … Quality control investigation - upon need yet not generally fundamentally before prequalification and supply, progressively as a major aspect of development

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Procurement, Quality and Sourcing Project Prequalification essential standards Voluntary for taking an interest makers Legitimate - General technique and principles affirmed through WHO Expert Committee framework including all WHO Member States and WHO Governing bodies Widely talked about in numerous fora FIP Congress, Nice 2002 Supported by ICDRA in 2002 and 2004, speaking to more than 100 national medication administrative specialists Transparent (all data accessible on the site http://www.who.int/meds/) Open to both trailblazers and multisource/non specific producers No cost for candidates amid pilot stage

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Some applicable ICDRA 2004 recommendatins WHO is asked to make - as an issue of criticalness - display rules for administrative endorsement of solution just settled measurements mix drugs with unique accentuation on medications for transmittable illnesses with high general wellbeing sway. Controllers have a part and duty to encourage access to medications of general wellbeing significance incorporating proposing changes in the particular directions so as to encourage access without trading off on quality, security and viability. WHO ought to proceed pre-capability of medications for need ailment programs, especially HIV, intestinal sickness and TB. Nations ought to receive the WHO Guidelines on Developing Measures for Combating Counterfeit Drugs, raise open and political familiarity with the issue, increment national, universal participation and information trade between all partners, including drug administrative specialists , intrigued nongovernmental associations , law implementation offices, businesses, and applicable worldwide associations. …

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Procurement, Quality and Sourcing Project Prequalification : false impressions and commentators Too elevated requirements expanding costs … Too high and pointless benchmarks for creating nations … Too bureaucratic and moderate, not proactive and not ready to give items… Too low norms … . " This leaves the impression with perusers that the ARVs endorsed by WHO are in certainty bland items that are compatible with their trend-setter cousins. From accessible archives, nonetheless, we reason that they are duplicate items with obscure quality, security and adequacy profiles".

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Procurement, Quality and Sourcing Project Prequalification: generics or not? FDA necessities for non specific medications ( www.fda.gov/cder/ogd ) Thus, a nonexclusive medications must: 1. contain an indistinguishable dynamic fixings from the pioneer tranquilizes as the trend-setter medication 2. be indistinguishable in quality, dose frame, and course of organization 3. have a similar utilize signs 4. be bio-proportionate 5. meet a similar clump necessities for character , quality, virtue and quality 6. be made under the same strict models of GMP required for pioneer items.

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WHO/HTP/EDM/QSM General technique: Prequalification What will be required for nonexclusive medications (1) ? 1. Points of interest of the item 2. Regulatory circumstance in different nations 3. Dynamic pharmaceutical ingredient(s) (API) 3.1 Properties of the dynamic pharmaceutical ingredient(s) 3.2 Sites of fabricate of API(s) 3.3 Route(s) of combination 3.4 Specifications API depicted in a pharmacopeia API not portrayed in a pharmacopeia 3.5 Stability testing WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-fourth report. Geneva, World Health Organization, 1996: 65-79(WHO TRS, No 863, as revised in 2002) http://www.ifpma.org/ich5q.html#stability

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WHO/HTP/EDM/QSM General methodology: Prequalification What will be required (2)? 4. Completed item 4.1. Formulation 4.2. Destinations of make 4.4. Fabricating technique 4.5 Specifications for excipients 4.6 Specifications for the completed item 4.7 Container/conclusion system(s) and other packaging 4.8 Stability testing

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WHO/HTP/EDM/QSM General method: Prequalification What will be required (3)? 4.9 Container naming 4.10 Product data 4.11 Patient data and bundle embeds 4.12 Justification for any distinctions to the item in the country or nations issuing the submitted WHO-sort certificate(s) 4.13 Interchangeability (bioequivalence considers) 4.14 Summary of pharmacology, toxicology and viability of the item

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WHO/HTP/EDM/QSM General technique: Prequalification Steps of the Procedure 1. Welcome for EOI Wide distribution Open, straightforward Specify items required 2. Rules for item dossier aggregation and necessities accessible Multi-source items Innovator items

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WHO/HTP/EDM/QSM General strategy: Prequalification 3. Accepting of dossiers 4. Screening of dossiers Screen for fulfillment Inform provider Listed for a conceivable site review 5. Dossier assessment Team of specialists (quality, pharmaceutical advancement, bio-proportionality and so on) From national administrative experts Standard: Including, yet not restricted to WHO Manual and rules " Marketing Authorization of Pharmaceutical Products with extraordinary Reference to Multisource (Generic) Products: a Manual for a Drug Regulatory Authority, WHO/DMP/RGS/98.5) Outcome of the assessment imparted to provider

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WHO/HTP/EDM/QSM General method: Prequalification 6. Site examination WHO GMP Inspection group: Appointed controller Experience, capability, ideally from DRA Local, national inspectorate WHO delegate 7. Report and result Reports on dossier assessment and site review Communicated to provider/maker Compliance? Extra data to be submitted?

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Pilot extend Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality: Quality Problems (I) Assessment – from ABC to XYZ API source, debasements, absence of steadiness information … need or inadequate bioequivalence information Manufacturing site examinations Manufacturers not prepared, frequently resistance with WHO cGCP Upgrading of offices to consent to WHO cGMP DRAs issued CPP – yet rebelliousness Inspections uncover rebelliousness, e.g. anti-infection agents (penicillin), hormones and different items produced in a similar site No approval Time expected to react to report "twofold benchmarks" – neighborhood versus universal market

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Problems experienced Access to HIV/AIDS Drugs and Diagnostics of Assured Quality: Quality issues (II) Specific issues : Unacceptable chiral movement, stereo-isomerism of dynamic pharmaceutical fixing (API) - conceivably dormant API CHIRALITY/ENANTIOMERIC PURITY Stavudine Lamivudine Indinavir (1/32 conceivable stereoisomers) Saquinavir mesylate (1/64 conceivable) Ritonavir Only one enantiomer enrolled and guaranteed in the pioneer's dossier EMEA/CPMP/375/96 EPAR : (- ) Lamivudine chose in light of the fact that less cytotoxic than (+) Lamivudine and the racemate (50:50 blend)

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Problems experienced Access to HIV/AIDS Drugs and Diagnostics of Assured Quality: Quality issues (III) CHIRALITY/ENANTIOMERIC PURITY: Lamivudine case (1): No data on the stereochemical setup No data on how the union can prompt to the right enantiomer  proof of structure/right enantiomer? No approval on assembling procedure of the API: just 2 clumps with cluster estimate obscure  group to-bunch consistency not illustrated/is a similar enantiomer acquired each time? Is it defiled with a similar measure of the undesirable stereoisomer each time? Nonappearance of control of the undesirable enantiomer in the completed pharmaceutical item including biobatch ...

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Problems experienced Access to HIV/AID

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