Speeding up access to markets: WHO Expert Review Panel & WHO accelerated registration procedure How manufacturers, procurers and patients benefit

Transcription

1 Speeding up access to markets: WHO Expert Review Panel & WHO accelerated registration procedure How manufacturers, procurers and patients benefit JOINT UNICEF, UNFPA & WHO MEETING WITH MANUFACTURERS AND SUPPLIERS OF DIAGNOSTIC PRODUCTS, FINISHED PHARMACEUTICAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS September 2013 Dr Joelle DAVIAUD, Quality Assurance Specialist

2 ERP (Expert Review Panel) Outline for pharmaceuticals Background/Fundamental principles Eligibility criteria ERP risk categories ERP experience so far Concluding remarks

3 Expert Review Panel (ERP) for pharmaceuticals GF TOR for ERP approved by GF in March 2009; ERP established in April 2009 together with WHO. Objective: To review the potential risk/benefit for FPPs not yet WHOprequalified or SRA-authorized, for the purpose of providing advise to help procurement decisions ERP risk categories developed by QSM/WHO. ERP is coordinated by the QSM/WHO ERP reviews are done by experienced regulatory professionals

4 Expert Review Panel mechanism (ERP) A panel of regulatory experts (hosted by WHO) assesses the potential risks/benefits associated with the use of medicines that are not yet WHO-prequalified or SRA-authorized and provides recommendation (eligibility criteria: GMP and pending PQ/SRA application, if not justified otherwise) Assesses in 6-8 weeks abbreviated product dossiers submitted by manufacturers (GMP, questionnaire + annexes) Makes time limited recommendations: validity maximum 12 months. Can be extended only under certain circumstances ERP status does not replace WHO PQ/SRA approval but should be seen as a step towards WHO PQ/SRA approval 4

5 ERP - Eligibility criteria Criteria 1 (products included in WHO PQP EOI or eligible for SRA/Pepfar submission) A product dossier has been submitted to PQP or SRA/Pepfar and is accepted for assessment The FPP manufacturing site is compliant with Good Manufacturing Practices (GMP) as certified by WHO PQP, SRA or PIC/S inspectors. Criteria 2 (products not included in WHO PQP EOI or eligible for SRA/Pepfar submission) The FPP manufacturing site is compliant with GMP as certified by WHO PQP, SRA or PIC/S inspectors.

6 ERP Review Process EOI publication: January & July Invitation by GF/ GDF EoI or ad-hoc request ERP evaluation within 6-8 weeks ERP report: May and November ERP coordinator: Organize a session Mfg dossiers submission: March & Sept (2 months) Conclusions sent to Mfg: June & December 2 weeks after ERP report receipt Submission by manufacturers GF: Eligibility screening GF to review the report and send conclusions to GDF and to the manufacturers, update the GF list ERP: Confirm eligibility ERP: Review submissions Prepare reports incl risk categories ERP coordinator: prepare final communication Report to GF Pool of experts GMP status (confirmation by PQP inspectors)

7 Major attributes for risk categorization The following major product attributes are used as a basis for comparing the products: a. GMP status of the manufacturing site - one of the eligibility criteria for ERP review b. FPP manufacturing process and FPP specification c. Stability data d. Evidence of therapeutic equivalence e. API source and API quality

8 Common reasons for rejection by ERP API manufacturer not compliant Efficacy data not submitted (anti-tb products) Unsatisfactory efficiency data: several major deficiencies (especially anti-tb products) Unsatisfactory specification, e.g. limits for impurities (especially ARV) Unacceptable comparator product Unsatisfactory stability results, e.g. out-of-limit results Insufficient stability data, e.g. from one batch only (especially ARVs)

9 ERP - possible outcomes of review "No objection" against procurement (Risk categories 1 or 2) "Objection" against procurement (Risk categories 3* or 4) Request for additional data * Risk category 3 can be considered only if there is no other option and the risks of not treating the disease is higher than the risk of using medicines not meeting all quality standards.

10 ERP experience and impact on access to assured quality products 9 rounds completed in May 2013, leading to a huge increase of products prequalified specifically for TB products in 2012 ARV T B Malaria ERP submis ERP submiss ERP WHO/S submis sion cat 1/2 WHO/SRA ion cat 1/2 RA sion cat 1/2 WHO/S RA (6) (27) ( 20) ( 8)

11 Impact of ERP status on procurement Notifications received for ERP reviewed products ARV 3 notifications 2 countries 3 Products NONE 1 notification 1 country 1 product 2 notifications 2 countries 2 products 2 notifications 2 countries 2 products MALARIA 29 notifications 12 countries 15 products 49 notifications 25 countries 18 products 33 notifications 17 countries 9 products 11 notifications 6 countries 6 products 8 notifications 5 countries 4 products TB 2 notifications 1 country 2 products (FLD) 77 notifications 32 countries 12 products (FLD) 93 notifications 50 countries 25 products (22FLD,3SLD) 63 notifications 41 countries 16 products (12FLD,4SLD) 9 notifications 2 countries 11 products (9FLD,2SLD)

12 Harmonization of quality standards save cost and time for manufacturers and buyers Alignment of GDF and UNITAID QA policies with GF QA Uniform stringent standards easy reference for countries/ users Unique message for manufacturers Common Expression of interest for ERP review Common Expert Review Panel (ERP) assessment Common pre-shipment Quality Control testing

13 ERP experience so far Extension of same ERP mechanism to other products/ Harmonisation between organisation 10 ERP sessions for GF, first session started in Feb 2009 Joint EOI GF-UNITAID in Dec ERP reviews for UNITAID started Sept Joint EOI GF-GDF in July 2010 (GDF aligned their QA policy with that of GF). ERP reviews for Neglected Tropical Diseases, NTD (WHO) (started April 2010) ERP reviews for Reproductive Health products (UNFPA) started ERP reviews to advice on extension of the validity period (progress of dossiers?) ERP reviews of variations to prequalified and SRA approved products. Outcomes are today used by: Global Fund; GDF; UNITAID, UNFPA; MSF; The Union; ICRC; UNICEF Equivalent process under discussion for diagnostics

14 Recommendations to manufacturers To ensure availability of adequate( medicine/formulation) products to patients Submit dossier to WHO Prequalification program and /or SRA Submit dossier for ERP review for the medicines/formulations for which not enough products are currently on the market ( refer to EoI published by WHO PQ and GF/GDF, GF/UNITAID ) Respond as soon as possible to WHO PQ questions as ERP is temporary solution To ensure efficient ERP process and increase number of products on the market : Ensure that all required details are provided, in full, in the submission. The recommendations of the ERP after review of the dossier, shall be compiled with, in full, during the next submission. Where additional data are requested, the same shall be provided, in full, to avoid unnecessary back and forth communications. To ensure appropriate Quality control testing/quality monitoring: Provide all necessary information to PRs to conduct quality control testing.

15 Ensuring availability of needed products Key benefit of ERP Securing the supply of needed products: Number of products early available on the market Most of products ERP reviewed became WHO PQ or SRA approved within 12 months: Accelerate availability of WHOPQ/SRA products Increase access by patients to affordable products of assured quality: Linezolid case, reduction of price from 75 $ to less than 2$ A single process with unified requirements : ERP conclusion/process recognized today by most of partners: Work towards harmonization of quality standards between partners National Program recognized ERP review added value: Indian TB program decided to procure ERP products This has helped to achieve shorter lead times and competitive prices Future perspectives :ERP reviews of additional essential medicines

16 THANK YOU