Cllabrative Registratin Prcedure fr Advancing Vaccines Cllabrative Registratin in Prcedure fr Advancing Vaccines Emerging Registratin Cuntries in Emerging Cuntries 19 th Annual General Meeting DCVMN 19 th Annual General Meeting DCVMN 31 Octber 2018 Kunming, China Regulatry frum fr manufacturers 31 Octber 2018 Kunming, China Emer Cke Emer Cke WHO Emer Cpenhagen, Directr Cke 26 Sept 2018 Regulatin Directr f Medicines Regulatin and ther f Medicines Health and ther Health Technlgies Technlgies
Key Themes f WHO s 13 th General Prgramme f Wrk 2019-2023 Missin Prmte Health - Keep the Wrld Safe - Serve the Vulnerable Strategic Pririties Health Cverage: 1 billin mre peple with health cverage Health Emergencies: 1 billin mre peple made safer Health Pririties: 1 billin lives imprved NEW Cluster at EB 2019 Access t Medicines, Vaccines and Pharmaceuticals (MVP) Dr. Mariângela SIMÃO, Assistant Directr General Radmap n access t medicines and vaccines http://www.wh.int/medicines/access_use/rad-map-medicines-vaccines/en/ 2
WHO Regulatry Activities: Fcus n Access and Outcmes Ensuring nrmative and technical excellence drives impact at cuntry level Technlgies, Standards and Nrms Regulatry Systems Strengthening Prequalificatin Prgramme Safety & Vigilance Set glbal nrms and standards (written & physical) and nmenclatures Increase cmmn understanding n regulatry requirements by authrity and manufacturer Standardize apprach used by quality cntrl labs Set effective and efficient regulatry systems in LMICs thrugh cllabrative & harmnized appraches with reliance principles Increase cnfidence in medical prducts prduced in LMICs Assure safety, quality, efficacy & apprpriateness f medical prducts used in LMICs: vaccines, medical devices, cld chain equipment, vectr cntrl prducts & in vitr diagnstics Increase cmpetitin t shape the market Increase knwledge f real life adverse events and crdinate actins taken against adverse events Mitigate risks and prtect against substandard / falsified prducts Cntain antimicrbial resistance Decreased regulatry burden Reduced time fr regulatin Increased regulatry capacity in LMIC Decreased cst f regulatin Reduced mrtality and mrbidity 3
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Frm Prequalificatin t Access: Hw d we get quality vaccines t every child, man and wman faster and mre efficiently? 5
Cllabratin, Reliance, Harmnizatin, Infrmatin Sharing 6
Accelerated registratin thrugh Cllabrative Registratin Prcedures (CRP) Objectives: t facilitate the assessment and accelerate natinal registratin f Prequalified prducts t accelerate registratin f health prducts that have already received apprval frm a stringent regulatry authrity Principles: Vluntary Svereignty Identicality C-peratin Reliance Mnitring and maintenance Svereignty: Participating NRAs agree t respect principles, but natinal requirements still apply, decisin remains natinal decisin Reliance: WHO PQT share the assessment reprts, inspectin reprts and labratry results with participating NRAs 7
CRP Participating NRAs Armenia Btswana Burkina Fas Burundi Camern *Caribbean Cmmunity (CARICOM) Cte d'ivire Dem. Rep. Cng Eritrea Ethipia Gergia Ghana Kenya Kyrgyzstan La PDR Madagascar Malawi Mali Mzambique Namibia Nigeria Pakistan As at 30 June 2018 Philippines Senegal Sierra Lene Suth Africa Sri Lanka Tanzania Thailand Uganda Ukraine Zambia Zanzibar Zimbabwe * CARICOM Member States: Antigua and Barbuda, Bahamas, Belize, Dminica, Grenada, Haiti, Jamaica, Mntserrat, Saint Lucia, St. Kitts and Nevis, St Vincent and the Grenadines, Suriname and Trinidad and Tbag Assciate Member States: Anguilla, Bermuda, British Virgin Islands, Cayman Islands and Turks and Caics Islands 8
CRP: Median time t registratin (> 350 registratins fr PQ Medicines) Days* 100 *Including regulatry time and applicant time Days 80 60 81 93 78 75 93 78 85 40 20 0 9
But what abut access t vaccines? sme examples f cllabratin MenAfriVac (2010) - Hw it wrked: Regulatry supprt frm Health Canada (HC) and Indian DCGI Fast track, expedited prcedure, prequalificatin apprach, using HC/DGCI assessment (PQed in 5 mnths) Wrkshp in AFRO fr sharing f reprts that were the basis fr PQ Benefits: Assessment resurces saved and targeted t ther activities, fr example, strengthening pst-marketing surveillance Successful registratin f MenAfriVac in 26 cuntries f the meningitis belt (2011) 10
Facilitating access t vaccines in Public Health Emergency (PHEIC r graded emergency) Pli end-game strategy SAGE (2012) recmmendatin t withdraw type 2 cmpnent f OPV in all cuntries, facilitated by the intrductin f at least ne dse f IPV Mapping regulatry status in all cuntries: 1) Already licensed 2) Accept PQed vaccine (waive) 3) Facilitated registratin Facilitated registratin: "Jint review" 1) Standard: EMRO (8 cuntries) 2) PQ apprach: AFRO (19 cuntries) SEARO (3 cuntries) Facilitated registratin f tw vaccines, IPV and bopv, in all cuntries 11
Experiences f CRP fr Vaccines 2016/7: Ukraine, Zimbabwe, DRC, Ethipia Ukraine Zimbabwe DRC Ethipia 2016 6 vaccines applied 2017 1 vaccine BCG (India) 2017 1 vaccine DTwP-HepB-Hib (Krea) 2017 1 Vaccine DTwP-HepB-Hib (Krea) 5 registered in < 12 mnths Registratin still pending Registratin still pending Registered Abut 6 mnths 12
Experiences f CRP fr Vaccines: 2017: wrkshp in Accra n ral chlera vaccine CRP wrkshp n registratin f PQed ral chlera vaccine manufactured in Krea Participating NRAs: Ghana, Nigeria, Tanzania, Uganda and representatives frm CARICOM Oral Chlera vaccine registered in: Nigeria in June 2018 - < 3 mnths CARICOM * in April 2018 - < 5 mnths * CARICOM Member States: Antigua and Barbuda, Bahamas, Belize, Dminica, Grenada, Haiti, Jamaica, Mntserrat, Saint Lucia, St. Kitts and Nevis, St Vincent and the Grenadines, Suriname and Trinidad and Tbag Assciate Member States: Anguilla, Bermuda, British Virgin Islands, Cayman Islands and Turks and Caics Islands 13
Experiences f CRP fr Vaccines: 2018 Thailand Ukraine Belarus 2018 Reduced registratin times 4 Pqed vaccines successfully registered by mre than 6 mnths, excellent reprts 2018 Tetanus (Indnesia) 2018 DTwP-HepB-Hib (Krea) Dcumentatin ready t be shared Dcumentatin ready t be shared Other mature authrities requesting reprts, particularly fr emergency prducts Wrk n Ebla vaccine nging with AVAREF 14
Optimizing CRP fr vaccines (1) Mapping f current regulatry pathways in cuntries critical t ensure efficient use f resurces Cuntries accepting PQed vaccines supplied thrugh UN Cuntries ready t accept CRP CRP Agreements extended t vaccines if necessary and fcal pints designated Identificatin f pssible cnstraints fr implementatin f the prcedure in cuntries. Need fr lcal agent in cuntries? understanding f inspectin and testing requirements, interest frm manufacturers t submit an applicatin? 15
Optimizing CRP fr vaccines (2) Fcussing resurces Need t define pririty vaccines and cuntries: fr example, pririty vaccines representing majr public health benefits r vaccines t cntain an utbreak r vaccines under shrtages cuntries with lng timelines, specific natinal requirements PQ t imprve preparedness fr sharing reprts Jint review ptin may als facilitate registratin ( nt CRP) But Dssiers need t be first submitted in cuntries Interest frm cuntries that will benefit frm the review - future champins Adjustments may be needed depending n knwledge base f cuntries 16
Key Messages Strng and efficient Regulatry systems use cncepts such as reliance, wrk-sharing and internatinal cllabratin Rich prtfli f cncepts, tls, netwrks and enablers nw exist e.g. Gd Regulatry Practices Cllabrative Registratin Prcedures Jint reviews, Reginal netwrks Mre wrk needed t translate int practical realities fr vaccines Plitical will and understanding as well as regulatry will are crucial the pwer f the patient and stakehlder vice the rle f regulatry champins Opprtunities t streamline in ther areas, e.g., pst apprval changes/variatins and inspectins 17
谢谢 A wrld where every child, man and wman has access t the quality essential medicines, vaccines and ther health prducts they need t lead a healthy and prductive life. CRP is a key enabler thank yu fr yur attentin Emer Cke Directr, Regulatin f Medicines and ther Health Technlgies 18