Collaborative Procedure to Accelerate Medicines Registration

Transcription

1 Collaborative Procedure to Accelerate Medicines Registration Pharmaceuticals Limited Mumbai, INDIA Challenging the Frontiers in Healthcare

2 Outline Introduction to Macleods Pharma. Regulatory filings by Macleods Pharma. Impact of WHO-PQ in last Decade on Macleods Registration issues faced by manufacturers Gist of Collaboration Procedure. Advantage of WHO NMRA Collaboration Macleods Experience with WHO NMRA Collaboration

3 Introduction 7 th ranked Pharmaceutical Company in India *(IMS-ORG Sept 15) Operates in 11main therapeutic divisions like Anti-TB, Anti-Malarial, Anti-Retro Virals, Anti-Bacterial, Anti-Diabetic, Anti-Osteoporotic, CNS, CVS, Respiratory Gastrointestinals& Topicals. 15 Finished Dosage Manufacturing Facilities One API Manufacturing Site which has 6 Blocks Supported by state- of-the- art R&D Centre & In- House Bioequivalence Centre Vertically Integrated Pharmaceutical Company Developing & Manufacturing APIs and Finished Dosage Forms Over 10,000 employees are at service to provide uninterrupted care Presence in more than 100countries

4 Regulatory-Dossiers & Approvals API DMF /CEP Application US :-Filed 54 API DMFs, Target to file 10-15DMFs every year EU :- CEP application:21 APIs and Received: 10 CEP approval USA Filing Filed 113 ANDAs, Received 47 approvals Target to file 20ANDAs every year Europe Filing 20 DCPs and Received 14 MA s mainly in UK, Germany, Spain and Italy

5 Impact of WHO-PQ on Macleods Business in last decade Macleods filed its first dossier to WHOPQ in 2005 Around 60 dossiers were filed in last decade 43 product approved & remaining products are under evaluation Access to global organizations like Global Drug Facility, Global Fund, IDA, UNICEF, UNDP, UNAIDS, CHAI, PAHO, MISSIONPHARMA etc One of the Global leaders in supply of Anti TB / Anti-Retrovirals & now currently developing market for Anti Malarials.

6 Registration Issues Faced By Manufacturers Products Approved by WHO/SRA In country registration requirement even for WHO-Approved products Faster Approvals Are Needed Process of registration is 2-3 years long, to enable mfg to commercialized its product in the country Lack Of Clear Timelines NMRAs registration time is longerdue to either man power shortage or the assessment schedule.

7 Gist of Collaboration Procedure Manufacturer/Applicant NMRA WHO-PQ PQ product is submitted for national registration to NMRA as registration dossier as per NMRA requirement along with the signed Appendix 2 Manufacturer informs PQP about national submission and gives consent with information sharing. Provide signed Appendix 2 and 3 to WHO-PQ NMRA confirms its interest PQP shares with participating NMRA outcomes of assessment and inspections Participating NMRA reviews WHO PQP outcomes, decides within 90 days decides upon the national registration and informs PQP about its decision

8 Advantages Of Collaborative Registration Process 1) Manufacturers Faster registration process than the general NMRA registration procedure (within 120 days) Lesser queries Approval in 26 countries (As on date) Simple procedure Harmonized data for PQ and national registration Facilitated interaction with NMRAs in assessment and inspections Accelerated and more predictable registration 2) Procurers Faster start of procurement and wider availability of PQ medicines Assurance about 'the same' medicine as is prequalified

9 Advantages Of Collaborative Registration Process (CONT..) 3) NMRAS Availability of WHO assessment and inspection outcomes to support national decisions and save internal capacities Assurance about registration of 'the same' medicine as is prequalified Quality control by same methods and specifications 4) Patients Faster availability of prequalified medicines

10 Experience with Collaborative Registration Process NAME OF COUNTRY NUMBER OF PRODUCTS REGISTERED NUMBER OF PRODUCTS UNDER REGISTRATION Nigeria 11 4 Zambia 8 5 Botswana 8 1 Ukraine 4 1 Ethiopia 3 6 Kenya * Zimbabwe 1 4 Ghana Namibia Tanzania Uganda 1 3 Total * Yet to be published on website

11 Experience with Collaborative Registration Process (CONT ) Time taken for registration of 40products was considerably reduced by Collaborative Registration Procedure. TIME LINE NO. OF PRODUCTS <3 months months 29 > 6 months 7

12 Points To Think Upon CHANNELS Direct access to MOH instead of going through channels which can assure timely submissions of dossiers & lesser probabilities of dossier misplacement / losing of dossier. DOSSIERS Submission of Pre-Qualified Dossier Summary rather than entire dossier Variation Gaps: Information should directly be shared to MOH by WHO FEES Additional fees requirement than usual by some of NMRAs when complete evaluation is already been done.

13 Conclusion Beneficial to all the stakeholders including manufacturers, patients and NMRAs. Reduce the registration timelines and allows early access to markets and smoothens registration process. Benefits maximum number of patients by providing them early access to new products.

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