Collaborative Procedure to Accelerate Medicines Registration
|
|
- Willis Arnold
- 6 years ago
- Views:
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.
14
Prequalification of medicines
Prequalification of medicines Wondiyfraw Worku WHO Prequalification Team 3.2.S.3.2 Impurities, Malaysia, 1 29 September 2011 CPHI Mumbai 2017 1 Background In early 2000, there was an increasing demand
More informationROLE OF RELIANCE, RE-ENGINEERING, AND REGIONALIZATION IN THE OPTIMIZATION OF REGULATORY SYSTEMS
ROLE OF RELIANCE, RE-ENGINEERING, AND REGIONALIZATION IN THE OPTIMIZATION OF REGULATORY SYSTEMS Murray M. Lumpkin, M.D., M.Sc. Lead for Global Regulatory Systems Initiatives Bill and Melinda Gates Foundation
More informationModel Quality Assurance System for procurement agencies. What it means for manufacturers?
Model Quality Assurance System for procurement agencies. What it means for manufacturers? JOINT UNICEF, UNFPA & WHO MEETING WITH MANUFACTURERS AND SUPPLIERS OF DIAGNOSTIC PRODUCTS, FINISHED PHARMACEUTICAL
More informationCritical Path to TB drug Regimens 2016 Workshop
Critical Path to TB drug Regimens 2016 Workshop AT A GLANCE Quality Pharmaceutical manufacturing company from Kenya Sales KES 2.26B (USD 22.6M) 2015 Unaudited 65% Business from Donors Portfolio of more
More informationGood Procurement Practices for artemisinin-based antimalarial medicines
Good Procurement Practices for artemisinin-based antimalarial medicines AMDS Partners and Stakeholders Meeting Geneva, 23 March 2010 Silvia Schwarte Medicines and Diagnostics Unit Global Malaria Programme
More informationPrequalification of Medicines Programme
Prequalification of Medicines Programme TB Alliance Open Forum 4 Key Issues in TB Drug Development Wondiyfraw Z. Worku Technical officer August 18-19, 2010 Addis Ababa, Ethiopia Out line Brief intro to
More informationWHO Prequalification of Medicines Programme
WHO Prequalification of Medicines Programme General overview and update Milan Smid, M.D., Ph.D. Slides benefiting from presentations of WHO PQP colleagues and BioBridge Strategies WHO PQP tutorial, 27
More informationPrequalification of APIs
Antony Fake PhD WHO Medicines Prequalification Programme 1 2 Abbreviations API Active Pharmaceutical Ingredient FPP Finished Pharmaceutical Product API PQ API Prequalification APIMF Active Pharmaceutical
More informationGLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE
GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE Finished Pharmaceutical Product Questionnaire This questionnaire is used to collect information from vendors with regards to finished pharmaceutical products
More informationPROGRESS REPORT JUNE 2013 WHO PREQUALIFICATION
PROGRESS REPORT JUNE 2013 WHO PREQUALIFICATION Content WHO Prequalification: Assuring the quality of key products...p 1 Vaccines... p 2 Medicines... p 6 Diagnostics and medical devices...p10 Future thinking...
More informationResearch Article. Southern Med Review. Abstract. Kirti Narsai 1,2, Abeda Williams 3, Aukje Kaija Mantel-Teeuwisse 2
Research Article Southern Med Review Impact of regulatory requirements on medicine registration in African countries perceptions and experiences of pharmaceutical companies in South Africa Kirti Narsai,2,
More informationProcurement of internationally quality assured (IQA) second-line drugs (SLDs): past, present, future
Procurement of internationally quality assured (IQA) second-line drugs (SLDs): past, present, future 12 November 2012 Dr Kaspars Lunte Team Leader MDR-TB medicines supply, GDF What is the Global Drug Facility?
More informationChallenges and Opportunities in Pharma: Perspective for an Emerging Middle East April 24th, 2015
Challenges and Opportunities in Pharma: Perspective for an Emerging Middle East 2020 April 24th, 2015 Content Pharma Market Landscape Global Pharma Market Market Categories Middle East Markets Major Challenges
More informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
More informationOVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS IN EMERGING MARKET
Badjatya et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 227-232 227 Available online at http://jddtonline.info REVIEW ARTICLE OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS
More informationSession 5: Increase in Use of the WHO Prequalification Programme
Session 5: Increase in Use of the WHO Prequalification Programme Perceived Need for Prequalification In an ideal world: Regulated pharmacies and service providers would supply medicines to clients Regulatory
More informationWorld Bank Training Program on HIV/AIDS Drugs
World Bank Training Program on HIV/AIDS Drugs Training Module 4 Quality Assurance PART 2 based on the World Bank document Battling HIV/AIDS: A Decision Maker s Guide to the Procurement of Medicines and
More informationWHO Prequalification Team (WHO-PQT) Introduction to medicines inspections technical updates
Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers of diagnostic products, vaccines, finished pharmaceutical products and active pharmaceutical ingredients WHO Prequalification Team (WHO-PQT)
More informationDrug Development Services
Drug Development Services Speaker Introduction Nik Burlew Vice President Regulatory and Strategic Development 25 Years in Pharma: Development, MFG and QA. Consulting for the last 13 years primarily to
More informationPrequalification Timeline Key Performance Indicators (KPIs)
1. Introduction The purpose of this document is to provide background information relating to prequalification (PQ) timeline indicators. It also covers harmonization of PQ timeline calculation, and the
More informationINDO AFRICA PHARMA MEET 24-27TH SEPT, Hotel Marriot Hussain Sagar Lane, Road, Hyderabad India SPONSORED BY PHARMEXCIL
INDO AFRICA PHARMA MEET 24-27TH SEPT, 2009 Hotel Marriot Hussain Sagar Lane, Road, Hyderabad India SPONSORED BY PHARMEXCIL Drug Registration procedures in Tanzania Nditonda B. Chukilizo and Adonis Bitegeko
More informationHARMONIZATION PROCESS FOR MEDICINES REGULATION IN THE SADC REGION MANDISA HELA HELA ON ON BEHALF OF SADC SADC SECRETARIAT GABORONE, BOTSWANA
HARMONIZATION PROCESS FOR MEDICINES REGULATION IN THE SADC REGION MANDISA HELA HELA ON ON BEHALF OF OF SADC SADC SECRETARIAT GABORONE, Map of SADC Member-States Southern African African Development Community
More informationCadila Healthcare Ltd. Investor Presentation February 2010
Cadila Healthcare Ltd. Investor Presentation February 2010 1 Our Vision Zydus shall be a leading global healthcare provider with a robust product pipeline and sales of over $1 bn by 2010; we shall achieve
More informationSECRETARY, DEPARTMENT OF PHARMA,GOVT. OF INDIA INDO AFRICA BUSINESS SUMMIT AT HYDERABAD
*ADDRESS BY SHRI ASHOK KUMAR, IAS, SECRETARY, DEPARTMENT OF PHARMA,GOVT. OF INDIA INDO AFRICA BUSINESS SUMMIT AT HYDERABAD Shri Anand Sharmaji, Hon ble Minister of Commerce & Industry, Govt. of India,
More informationPortfolio management and product development in Actavis. 8 May 2007 Sigurdur O. Olafsson Deputy CEO
Portfolio management and product development in Actavis 8 May 2007 Sigurdur O. Olafsson Deputy CEO Disclaimer Any statement contained in this presentation that refers to Actavis estimated or anticipated
More informationTransition to WHO-PQ. Vector control product evaluation. TITLE from VIEW and SLIDE MASTER 16 June 2016
Transition to WHO-PQ Vector control product evaluation 1 Key PQ activities to achieve transformation have been defined in the recently awarded grant 1 2 3 4 5 Improve quality and efficiency of vector control
More informationCadila Healthcare Ltd. Investor Presentation August 2010 BSE : NSE : CADILAHC 1
Cadila Healthcare Ltd. Investor Presentation August 2010 BSE : 532321 NSE : CADILAHC 1 Our Vision Zydus shall be a leading global healthcare provider with a robust product pipeline and sales of over $1
More informationprogramme activities in 2005
VITAL TO HEALTH GOALS Imagine carrying your weak and feverish child to the nearest health clinic. Imagine the doctor making his diagnosis and prescribing an expensive antimalarial drug. Reassured that
More informationMID-TERM REVIEW OF THE UNITAID- FUNDED WHO PREQUALIFICATION PROGRAMME
UNITAID REQUEST FOR PROPOSAL BID REFERENCE 2010.005 IMPLEMENTATION OF MID-TERM REVIEWS OF UNITAID-SUPPORTED PROJECTS MID-TERM REVIEW OF THE UNITAID- FUNDED WHO PREQUALIFICATION PROGRAMME EVALUATION REPORT
More informationICH Q12: Perspectives on Post-approval
ICH Q12: Perspectives on Post-approval September 6 th 2016 Ciudad de México Renan Gois Health Regulatory Expert Office of Evaluation of Post-approval Changes for Small Molecules Disclaimer This presentation
More informationSaving Lives Through Stronger Supply Chains
Saving Lives Through Stronger Supply Chains Consultative Meeting on Procurement of Laboratory Items W.H.O., Geneva Rochika G. Chaudhry Technical Assistance Manager Overview SCMS overview SCMS Technical
More informationPharmaceutical product technical requirements and the Interagency pharmaceutical product questionnaire
Pharmaceutical product technical requirements and the Interagency pharmaceutical product questionnaire Atieno Ojoo Technical specialist, Pharmaceuticals UNICEF Supply Division 20 th October 2008, UNICEF
More informationICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Keith O. Webber, Ph.D. Sr. Director, Global Regulator Affairs Rx Perrigo Company, plc Q U A L I T Y A F F
More informationErasmus Mundus Master Program in Plant Breeding emplant. Selection results Intake 1 ( ) Candidates under EM-scholarships
Erasmus Mundus Master Program in Plant Breeding emplant Selection results Intake 1 (2018-2020) Candidates under EM-scholarships 1. Program Country Students a. Main list (selected students) b. Reserve list
More informationTaking a Leap Toward Global Supply Chain Efficiency - Part II
Taking a Leap Toward Global Supply Chain Efficiency - Part II 2 Supply Chain Brochure - Part II INTRODUCTION Pharmaceutical manufacturers face a number of challenges in the production and delivery of medicinal
More informationFinancial Accounting Advisory Services
Financial Accounting Advisory Services May 2013 Agenda About EY 3 5 Indian Companies Bill 2012 8 Appendix 14 Contacts 15 This document is only for circulation to the EY network outside India. Page 2 About
More informationGlobal Clinical Trials in Korea
Global Clinical Trials in Korea In-Sook Park Department of Drug Evaluation Korea Food & Drug Administration Contents Regulatory changes relevant to Clinical Trials in Korea Current Status of Clinical Trials
More informationCapital Market Day June 12, 2012
Capital Market Day 2012 June 12, 2012 Product Segments IV Drugs John Ducker Member of the Management Board President Region North America Capital Market Day Fresenius Kabi, June 12, 2012 Agenda 1 2 3 4
More informationHIKMA PHARMACEUTICALS PLC. Merrill Lynch Middle East & North Africa (MENA) Conference 13 December r 2005
HIKMA PHARMACEUTICALS PLC Merrill Lynch Middle East & North Africa (MENA) Conference 13 December r 2005 Important notice This document and its contents are confidential and may not be redistributed or
More informationEng. Exaud Mushi MSc, BSc (Hons) Eng. FIET(TZ), FICE (UK) Managing Director, NORPLAN (T) LTD
1 Eng. Exaud Mushi MSc, BSc (Hons) Eng. FIET(TZ), FICE (UK) Managing Director, NORPLAN (T) LTD Vice President FIDIC Sept. 2015 Todate Member: FIDIC Board of Directors(2012 Todate) Member: Engineers Registration
More informationBrexit Guidance for Stakeholders Human and veterinary medicines
Brexit Guidance for Stakeholders Human and veterinary medicines DATE: 03 JANUARY 2018 V.2 This guide does not purport to be an interpretation of law and/or regulations. The content provided is subject
More informationLEADING VERTICALLY INTEGRATED GENERIC PLAYER. January 2016
LEADING VERTICALLY INTEGRATED GENERIC PLAYER January 2016 Disclaimer This presentation is provided for informational purposes only and does not constitute or form part of any offer or invitation to sell
More informationEUROPEAN TECHNOLOGY PLATFORM NANOMEDICINE. Work plan for GA, 16th January 2008
Work plan for 2008 1 Vision In 10 years nanomedicinebased products will lead to breakthroughs in the treatment of diseases such as cardiovascular disease, cancer, CNS diseases and diabetes. 2 The ETP is
More informationUNICEF Quality Assurance in the procurement of medicines
UNICEF Quality Assurance in the procurement of medicines Peter S. Jakobsen 30 October 2006 Quality Assurance Centre SUPPLY DIVISION Today s presentation addresses 3 questions: How is UNICEF involved in
More informationA STUDY ON VARIATIONS IN PHARMACEUTICAL PRODUCTS IN PHILIPPINES AND VARITAION POLICIES IN US, CANADA, AUSTRALIA
ISSN: 2230-7346 Jignesh Shah et al. / JGTPS / 6(1)-(2015) 2340 2344 (Review Article) Journal of Global Trends in Pharmaceutical Sciences Journal home page: www.jgtps.com A STUDY ON VARIATIONS IN PHARMACEUTICAL
More informationFinancial Accounting Advisory Services
Financial Accounting Advisory Services Alignment of risk management, compliance, internal audit and internal control systems October 2014 Agenda 3 About EY 14 Contacts 16 Page 2 Harmonizing governance
More informationContents. Deloitte s Capabilities in the Public Health Sector. Leadership and Governance. Supply Chain Management. Organisational Development
Public Health Contents Deloitte s Capabilities in the Public Health Sector 1 Leadership and Governance 3 Supply Chain Management 3 Organisational Development 4 Health Finance 6 Data Management and IT
More informationArticle 58 Strategic Review Summary
Article 58 Strategic Review Summary Article 58 was introduced in 2004 to allow the EMA s Committee for Medicinal Products for Human Use (CHMP), in cooperation with the World Health Organization (WHO),
More informationImpact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004
Impact of the transposition of the European Clinical Trials Directive CEMO, Paris 17 November 2004 Dr Martine Dehlinger-Kremer VP Regulatory Affairs International Agenda Overview of key areas of Directive
More informationStatistics and recommendations from the First Global Forum on Medical Devices 9-11 September, 2010 in Bangkok
Statistics and recommendations from the First Global Forum on Medical Devices 9- September, 200 in Bangkok Participants to the Global Forum Professional and International Organizations 9% Independent consultants
More informationGlobal Serialisation Developments and the Need for Convergence. Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015
Global Developments and the Need for Convergence Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015 Developments across the world Regulatory bodies need to address Public Health issues one
More informationPROMOTING AND SUPPORTING LOCAL MANUFACTURING OF QUALITY MEDICAL PRODUCTS IN DEVELOPING COUNTRIES
Planar PROMOTING AND SUPPORTING LOCAL MANUFACTURING OF QUALITY MEDICAL PRODUCTS IN DEVELOPING COUNTRIES The Business Case for The local manufacturing initiative is implemented by WHO and its partners,
More informationProgress Report on Recommendations of 14 th International Conference of Drug Regulatory Authorities (ICDRA) from WHO South-East Asia Region (SEAR)
Progress Report on Recommendations of 14 th International Conference of Drug Regulatory Authorities (ICDRA) from WHO South-East Asia Region (SEAR) 14 th ICDRA, Singapore, December 2010 Dr K A Holloway,
More informationThe Emerging Technology Program: FDA s Perspective
The Emerging Technology Program: FDA s Perspective Mohan Sapru, M.S., Ph.D. Member Emerging Technology Team (ETT) CMC Lead Application Technical Lead Office of New Drug Products Office of Pharmaceutical
More informationThe Greatest Masterpieces were once only pigments on the palette. Towards Better Healthcare
The Greatest Masterpieces were once only pigments on the palette. Wanbury Limited Towards Better Healthcare DYNAMIC GROWTH Fast growing pharmaceutical Company with diversified revenue streams Wanbury is
More informationINVESTOR PRESENTATION. November 2017
INVESTOR PRESENTATION November 2017 Disclaimer This presentation contains statements that constitute forward looking statements including and without limitation, statements relating to the implementation
More informationMEDICINES CONTROL COUNCIL
MODULE 1 1.2.1 MEDICINES CONTROL COUNCIL APPLICATION FOR REGISTRATION OF A MEDICINE 1 Module 1: Administrative Information Application Form This application form will be included in the South African Common
More informationProducts: A Global Perspective
CMC Changes to Biotechnology Products: A Global Perspective from Industry Toshiko Mori-Bajwa Director, Regulatory Affairs, CMC Amgen, Inc. All Changes are Not Considered Equal Innovator Process Change
More informationRegulatory system strengthening
SIXTY-SEVENTH WORLD HEALTH ASSEMBLY A67/32 Provisional agenda item 15.6 14 March 2014 Regulatory system strengthening Report by the Secretariat 1. The Executive Board at its 134th session noted an earlier
More informationBiocon Reports a Strong Q1FY17 Revenues at Rs 952 Crore, up by 11 %; EBITDA Up 15% to Rs 271 Crore Net Profit Up 17% at Rs 147 Crore
Press Release Biocon Reports a Strong Q1FY17 Revenues at Rs 952 Crore, up by 11 %; EBITDA Up 15% to Rs 271 Crore Net Profit Up 17% at Rs 147 Crore Bengaluru, India: July 21, 2016 Biocon Ltd (BSE code:
More informationTechnical updates medicines inspections: Finished Pharmaceutical Products (FPP)
Technical updates medicines inspections: Finished Pharmaceutical Products (FPP) Vimal Sachdeva, Technical Officer (Inspector) WHO Prequalification Team (PQT), WHO/HIS/EMP/RHT 20 Avenue Appia, CH - 1211,
More informationPQTm Quality update. Lynda Paleshnuik Lead quality assessor
PQTm Quality update Lynda Paleshnuik Lead quality assessor 1 OVERVIEW Preparing to submit your dossier PQTm quality guidelines including WHO publications Assessing and using the principle quality guidelines
More informationInt. J. Pharm. Sci. Rev. Res., 31(2), March April 2015; Article No. 04, Pages: A Review on Drug Approval in Regulated and Non-Regulated Markets
Review Article A Review on Drug Approval in Regulated and Non-Regulated Markets Vemuri Pavan Kumar, N Vishal Gupta* Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy,
More informationMalaria Testing and Treatment Market Data
Malaria Testing and Treatment Market Data Malaria RDT and fever case management in the private health care sector in Africa consultative working meeting 20-21 October, 2015 Entebbe, Uganda ACTwatch is
More informationINVESTMENT ON PHARMACEUTICALS: THE VIEW OF MINISTRY OF HEALTH
INVESTMENT ON PHARMACEUTICALS: THE VIEW OF MINISTRY OF HEALTH Dra. SRI INDRAWATY, Apt.,M.Kes. Director General of Pharmaceutical Service and Medical Device PRESENTED ON : EU-INDONESIA BUSSINESS DIALOGUE
More informationGUIDELINES FOR SUBMISION OF POST- APPROVAL VARIATION MEDICINE APPLICATIONS
GUIDELINES FOR SUBMISION OF POST- APPROVAL VARIATION MEDICINE APPLICATIONS FOOD, MEDICINE AND HEALTH CARE ADMINSTRATION AND CONTROL AUTHORITY OF ETHIOPIA (EFMHACA) First Edition December, 2015 Table of
More informationPrequalification of Medicines Programme. WHO PUBLIC INSPECTION REPORT (WHOPIR) API Manufacturer
Prequalification of Medicines Programme SOP 408.4 Annex B WHO PUBLIC INSPECTION REPORT API Manufacturer Part 1: General information Name of Manufacturer Unit number WHO PUBLIC INSPECTION REPORT (WHOPIR)
More informationINVITATION TO BID ITB-IDA/GDF - SLD/2018/002 Issue date: 8 December 2017
INVITATION TO BID ITB-IDA/GDF - SLD/2018/002 Issue date: 8 December 2017 IDA Foundation (IDA), as the contracted Procurement Agent of the Stop TB Partnership/Global Drug Facility (GDF), wishes to procure
More informationWHO Prequalification Programme: Priority Essential Medicines WHO API GMP Inspections
WHO Prequalification Programme: Priority Essential Medicines WHO API GMP Inspections Presented by Mr. Ian Thrussell Head of Inspections WHO thrusselli@who.int In this presentation: WHO-PQ: Inspection activities
More informationOfficial Letter from the DOH
Issued Date 2009/04/02 Issued by DOH Ref. No 0980316268 RE The DOH issued an official letter to announce the implementation of the Guideline for BA/BE Studies on April 2, 2009 (Ref. No. 0980316265). Please
More informationExperience of Post approval change management protocol in EU. Mats Welin Senior expert Medical Products Agency Uppsala, Sweden
Experience of Post approval change management protocol in EU Mats Welin Senior expert Medical Products Agency Uppsala, Sweden Regulatory oversight What is in the filed dossier Descriptions of processes
More informationQuality Assurance of Medicines Terminology Database - List of Terms and related guideline
Accelerated (stress) stability studies Stability of drug dosage forms (Annex 1, 31st report, 1990) Studies designed to increase the rate of chemical or physical degradation of a drug by using degradation
More informationSaving people money. so they can live better. Walmart Ethics vs. Compliance 9/9/2011. Global Presence Retail Market Locations.
Walmart Ethics vs. Compliance Kirstie Sims, Divisional Compliance Director Mauri Myers, Director, U.S. Ethics Saving people money Image Area so they can live better Global Presence Retail Market Locations
More informationCapacity Building Workshop on Development of CDM Activities and NAMA for Public And Private Sector In Zimbabwe
CDM Project Cycle Capacity Building Workshop on Development of CDM Activities and NAMA for Public And Private Sector In Zimbabwe Nyanga, Zimbabwe 24 25 August 2016 UNFCCC Secretariat UNFCCC RCC UNFCCC
More informationGlobal Biologics Regulatory Trends Challenges and Opportunities..
Global Biologics Regulatory Trends Challenges and Opportunities.. Wassim Nashabeh VP, Regulatory Policy and International Operations F.Hoffmann La-Roche, Basel, Switzerland picture placeholder Page 2 N-linked
More informationInvestigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents
Investigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents Executive summary 14 Introduction and background to clinical trials 14 Financial considerations
More informationPRAXIS. A publication by Bioengineering AG
PRAXIS A publication by Bioengineering AG Portrait of Rentschler Biotechnologie GmbH, a globally active service company that supports its clients in the development, production, and registration of biopharmaceuticals.
More informationAn Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies. SPEAKER: Suzanne Murray Biogen
An Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies SPEAKER: Suzanne Murray Biogen Contents 1. BioPhorum Operations Group (BPOG) and the Post-approvals
More informationSituation as of November 2016
Situation as of November 2016 - - The FAO/GIEWS Country Cereal Balance System (CCBS) is a database of annual supply and utilization balances for main cereals, covering all countries of the world. It has
More informationTrinity College Dublin QP Forum 2017 Tuesday 25 th April
Trinity College Dublin QP Forum 2017 Tuesday 25 th April HPRA QUESTIONS & ANSWERS 1. What is the approach being taken for audit of contamination control strategies as per chapters 3 & 5? What is the current
More informationCANADA (HEALTH CANADA)
1 GMP GAZETTE TM May 2016 HPFBI CANADA (HEALTH CANADA) No updates NNHPD NHPs Final Monograph for Antiseptic Skin Cleanser Who`s Affected? Companies seeking NPN or DIN for topical antiseptic hand cleansers
More informationWHO Diagnostics Prequalification Project (DxPQ) and WHO Medicines Prequalification Project (MPQ) Mid-Term Evaluation
UNITAID WHO Diagnostics Prequalification Project (DxPQ) and WHO Medicines Prequalification Project (MPQ) Mid-Term Evaluation Revised June 1, 2016 Unitaid This publication was prepared independently, by
More informationEnding Eclampsia seeks to expand access to proven, under-utilized interventions and commodities for the prevention, early detection, and treatment of
Presenter Date 2015 Ending Eclampsia seeks to expand access to proven, under-utilized interventions and commodities for the prevention, early detection, and treatment of pre-eclampsia and eclampsia and
More informationClinical Trials application process, legislation & guidelines
Clinical Trials application process, legislation & guidelines IMB Clinical Trials Seminar 19 th June 2012 Elaine Breslin MB BCh (NUI), PhD, FRCPI Clinical Assessment Manager 19/06/2012 Slide 1 IMB Mission
More informationCipla products are bought by over 180 countries located in the following regions:
Date: 16/12/2010 CORPORATE INFORMATION: During the fiscal year ended March 31, 2010, the Company introduced a number of new drugs and formulations, such as Advent Forte (amoxicillin and clavulanic acid
More informationCDER /OPQ Office of Surveillance Quality Metrics in Surveillance
CDER /OPQ Office of Surveillance Quality Metrics in Surveillance Russell Wesdyk Acting Director Office of Surveillance Office of Surveillance Goals Builds from the shared vision A maximally efficient,
More informationManagement Team. Over 35 years experience in the pharmaceuticals industry
2017 1 Overview Located in Bangalore, a Dedicated cgmp and cglp Compliance Laboratory Established in September 2010 Approved Contract research Organization by India FDA Approved by Health Canada since
More informationCadila Healthcare Limited Investor Presentation
Cadila Healthcare Limited Investor Presentation March 2017 A Leading Pharmaceutical Company #4 Leading pharmaceutical company in India 1 Market share of 4.2% With a Global Footprint Revenue Split for 9MFY17
More informationPPB Guideline to submission Page 1 of 94
REPUBLIC OF KENYA REGISTRATION OF DRUGS GUIDELINES TO SUBMISSION OF APPLICATIONS PHARMACY AND POISONS BOARD PPB Copyright 2010 PPB Guideline to submission Page 1 of 94 ACKNOWLEDGEMENTS The following persons
More informationActavis Italy. Nerviano Plant
Actavis Italy Nerviano Plant Starting out in 1901 in Jerusalem The company known today as Teva was established as a small wholesale drug business by Chaim Salomon, Moshe Levin and Yitschak Elstein. (They
More informationRegulatory Affairs, Compliance Assurance, Quality Systems, Remediation Strategy and Support, and Strategic Consulting Services
Regulatory Affairs, Compliance Assurance, Quality Systems, Remediation Strategy and Support, and Strategic Consulting Services At Regulatory Compliance Associates Inc. (RCA) we understand the complexities
More informationJoint statement on public disclosure of results from clinical trials
Joint statement on public disclosure of results from clinical trials Signatories on 18 May 2017 European Commission for Horizon 2020 Societal Challenge Health Demographic Change and Wellbeing (joined on
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL QUESTIONS. and ANSWERS
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, F2/SM D (2008) QUESTIONS and ANSWERS The rules governing medicinal products in the European Union VOLUME 2 NOTICE
More informationRapid Diagnostic Tests in malaria case management
Rapid Diagnostic Tests in malaria case management Planning, Procuring and Implementing Suggestions for incorporation of malaria RDT-based diagnosis into proposals to the Global Fund Foundation for Innovative
More informationPrequalification Team Inspection services WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer. Tablets
Prequalification Team Inspection services WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer Part 1: information about the inspection Name of manufacturer Physical address production departments
More informationRegulatory Considerations and Trends Europe and the U.S.
Regulatory Considerations and Trends Europe and the U.S. Professor Kjell Strandberg MD PhD Chairman NDA Advisory Board, NDA Regulatory Science Ltd UK Former CPMP Member and Director General Medical Products
More information1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country
1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country S no 1. Name of Applicant with address 2. Name of Drug 3. Therapeutic Class 4. Date of Approval Documents
More informationEvolution of the CMC Review - ANDAs
Evolution of the CMC Review - ANDAs Susan Rosencrance, Ph.D. Director (Acting), Office of Lifecycle Drug Products Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research October 6,
More information