Pharmacy and Poisons Board The New Kenyan Drug Regulation Guidelines Mwavali Humphreys Pharmacy and Poisons Board, Kenya SAPRAA, 17 -18 th November 2011 1 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Background Vision and Mission Organogram Services Clients and Stakeholders Achievements ABOUT PHARMACY AND POISONS BOARD (PPB) 2 www. pharmacyboardkenya. org
Pharmacy and Poisons Board REPUBLIC OF KENYA MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS BOARD Ensuring the provision of quality, safe and efficacious pharmaceutical products and services. THE PHARMACY AND POISONS BOARD 3 www. pharmacyboardkenya. org
Pharmacy and Poisons Board BACKGROUND. . . 1 • Established as a Regulatory Authority under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya • Commenced operation on the 1 st of May 1957. 4 www. pharmacyboardkenya. org
Pharmacy and Poisons Board BACKGROUND. . . 2 • It is a semi autonomous body • Can sue and be sued, • Can acquire, hold and dispose property. • It can also borrow and lend money. 5 www. pharmacyboardkenya. org
Pharmacy and Poisons Board BACKGROUND. . . 3 • The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons. 6 www. pharmacyboardkenya. org
Pharmacy and Poisons Board MISSION OF THE BOARD To improve the quality of life of Kenyans by ensuring provision of good quality, safe and efficacious pharmaceutical products and services in Kenya 7 www. pharmacyboardkenya. org
Pharmacy and Poisons Board VISION OF THE BOARD To be global leader in the control and regulation of drugs (food, chemicals) poisons and practice of pharmacy 8 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR HEAD OFFICE www. pharmacyboardkenya. org
Pharmacy and Poisons Board Membership of the Pharmacy and Poisons Board … 1 The Board of Directors consists of the following: • Chairman -Director of Medical Services, Go. K. • Registrar -Chief Pharmacist, Go. K • Director of Veterinary Services 10 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Membership of the Pharmacy and Poisons Board … 2 • Four Pharmacists nominated by the Pharmaceutical Society of Kenya of whom one represents: – The Civil Service – Community Pharmacy – The Pharmaceutical Industry 11 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Membership of the Pharmacy and Poisons Board … 3 • A representative from the Faculty of Pharmacy U. o. N • A Pharmaceutical Technologist 12 www. pharmacyboardkenya. org
Pharmacy and Poisons Board MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS BOARD ORGANISATION BOARD OF DIRECTORS REGISTRAR (DR. KOSKEI) DEPUTY REGISTRAR (DR. SIYOI) HEAD LEGAL AFFAIRS HEAD TRADE AFFAIRS (DR. YANO) (DR. KIMATHI) HEAD, QUALITY ASSURANCE (DR. KIMATU) BUSINESS SUPPORT DIRECTORATE (DR. OCHIENG) PRODUCT EVALUATION & REGISTRATION DIRECTORATE (DR. NJUE) INSPECTORATE & SURVEILLANCE DIRECTORATE (DR. WASIKE) PHARMACY PRACTICE SECTION (DR. GACHOKI) GOOD MANUFACTURING PRACTICE (DR. WASIKE) (DR. SIFUMA) REGISTRATION & ENROLMENT SECTION (**) GOOD DISTRIBUTION PRACTICE (DR. OWUOR) FINANCE (MR. MUGUNI) DRUG EVALUATION & REGISTRATION (DR. MUNYOROKU) C. P. D. (DR. INYANGALA) PORTS OF ENTRY (MR. KIPTOO) PROCUREMENT (MR. TSUMA) EVALUTION AND REGISTRATION VETERINARY SECTION (DR. NZUMBU) ICT (MR. MURIMI) HRM/EXEC. SEC. (MS. ODONGO) PHARMACOVIGILANC E & MEDICINES INFORMATION (DR. JAYESH) PHARMACY PRACTICE & REGULATION DIRECTORATE (DR. MOHAMED) HERBS & MEDICAL DEVICES 13 www. pharmacyboardkenya. org
Pharmacy and Poisons Board CORE VALUES. . . 1 1. Highest Professional & ethical practices. 2. Honesty & integrity 3. Fairness & equity 4. Diligence and excellence 5. Efficacy and effectiveness 14 www. pharmacyboardkenya. org
Pharmacy and Poisons Board CORE VALUES. . . 2 6. Transparency & accountability 7. Innovativeness/creativity and continuous improvement 8. Teamwork, networking and partnership with other organizations 15 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR SERVICES. . . 1 • Product Evaluation and Registration • Evaluation of Applications for Advertisements of Medicines and Medical Devices • Ensuring Good Manufacturing Practice (GMP) • Pharmaco-vigilance and Post-Market Surveillance 16 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR SERVICES … 2 • Registration of Pharmacists • Enrolment of Pharmaceutical Technologists • Issuance of Annual Practice Licenses • Issuance of Annual Permits for Pharmaceutical Representatives • Registration of Pharmaceutical Premises/Outlets 17 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR SERVICES … 3 • Approval of Institutions Offering Pharmacy Training Programs • Approval of Pharmaceutical Imports and Exports • Documentation and Information Services on Medicines and Pharmacy Practice • Public relations services 18 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR CLIENTS. . . 1 • Pharmaceutical Manufacturing Companies • Pharmaceutical Importers, Exporters, Distributors, Wholesalers and Retailers • Hospitals and other Healthcare Providers • Researchers 19 www. pharmacyboardkenya. org
Pharmacy and Poisons Board OUR CLIENTS. . . 2 • • • Pharmacy Practitioners Universities and Colleges Pharmaceutical Service Providers Suppliers Consumers 20 www. pharmacyboardkenya. org
Pharmacy and Poisons Board STAKEHOLDERS. . . 1 • Government Ministries and Departments • Development Partners • Pharmaceutical Society of Kenya • Kenya Pharmaceutical Association • Kenya Association of Pharmaceutical Industry (KAPI) 21 www. pharmacyboardkenya. org
Pharmacy and Poisons Board STAKEHOLDERS. . . 2 • • • External Quality Assurance Agencies Research Organizations Industry and Private Sector Pharmacy Students Consumers The Public 22 www. pharmacyboardkenya. org
Pharmacy and Poisons Board REFORMS AND ACHIEVEMENTS 1. Regional and International Collaboration 2. Training of Health Care Providers in Pharmaco-vigilance and Post Market Surveillance System 3. Secured supply 4. Use of cutting edge anticounterfeiting technologies 23 www. pharmacyboardkenya. org
Pharmacy and Poisons Board REFORMS AND ACHIEVEMENTS 5. Enhanced capacity of Inspectorate 6. The Anti-Counterfeit Bill of 2008 6. Immediate Destruction of Expired Drugs 7. Good Manufacturing Practice 8. Development of New Regulation 24 www. pharmacyboardkenya. org
Pharmacy and Poisons Board CTD Guidelines-What is new? General Requirements Format Registration Process Common Pitfalls Variations NEW PPB DRUG REGISTRATION GUIDELINES 25 www. pharmacyboardkenya. org
Pharmacy and Poisons Board CTD Guidelines-What is new? • A common format for the preparation of a well-structured application. • More details on requirements for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) • Requirements on bioequivalence and bio-waver(s) have been updated. 26 www. pharmacyboardkenya. org
Pharmacy and Poisons Board General Requirements (1) • Complete application form • One hard copy • One soft copy (CDRom) with full dossier in Portable Document Format, (PDF) and MSWord document for Modules 1 and 2, adequately cross-referenced to the dossier • DO NOT FILL the blue areas indicated: ‘for PPB Official Use Only!’ 27 www. pharmacyboardkenya. org
Pharmacy and Poisons Board General Requirements (2) • Language: English and legible (a copy in the original language and a full translation) • A 4 and 80 g/m paper with readily readable letters of at least 12 font sizes • Every page should be numbered sequentially • State the exact location (Annex number) of any appended documents in the relevant sections 28 www. pharmacyboardkenya. org
Pharmacy and Poisons Board General Requirements (3) • All parts must be bound arranged sequentially • The left-hand margin should be sufficiently large • Thick and hard enough not to collapse in standing position • For references in compendia, text books or standard publications, provide reprints or authenticated copies of relevant pages 29 www. pharmacyboardkenya. org
Pharmacy and Poisons Board General Requirements(4) • Three (3) samples of the smallest commercial pack(s) from one batch • Current GMP certificate for site of manufacture from PPB • Pre-registration analysis (PPB approved lab) • Registration status in country of origin 30 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Format(1) • Module 1. Administrative Information and Prescribing Information • Module 2. Chemical, Pharmaceutical, Non-clinical And Clinical Overviews And Summaries 2. 1. Overall Table Of Contents Of Modules 2, 3, 4, And 5 2. 2. Introduction 2. 3. Overall Quality Summary 2. 3. 1. Overview API(s) 2. 3. 2. Overview Of Finished Pharmaceutical Product(s) [FPP(s)] 31 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Format(2) • Module 3. Chemical-pharmaceutical Documentation 3. 1. Table of contents of Module 3 3. 2. Body of data 3. 2. 1. Particulars of active pharmaceutical ingredient(s) [FPP(s)] 3. 2. 2. Particulars of finished pharmaceutical product(s) [FPP(s)] 32 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Format(3) • Module 4. Non-clinical Study Reports 4. 1. Table of contents of Module 4 4. 2. Study reports 4. 3. Literature references 33 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Format(4) • Module 5: Clinical Study Reports 5. 1. New chemical entities only 5. 2. Interchangeability of generic drugs – (Generic drug applications only) 5. 3. Safety and Residues Documentation (for veterinary products only) 34 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Registration Process: Screening RECEIVING THE CTD DOSSIER, SAMPLES AND PAYMENT OF FEES REJECTED AND RETURNED TO OWNER SCREENING THE CTD DOSSIER (EVALUATOR) ACCEPT AND ALLOCATE A CTD NUMBER USING SIAMED STORE THE DOCUMENT, SAMPLES AND RECORD (SIAMED) 35 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Registration process: Evaluation FIRST EVALUATION (REPORT) SECOND EVALUATION (REPORT) RECOMMENDED FOR REGISTRATION/ QUERIES RAISED/ REJECTED (OPTION OF APPEAL) REGISTRATION (PRACTICE COMMITTEE) GAZZETMENT 36 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Common Pitfalls: Screening • • Format Address of applicant Trade name and packaging of product. Product pack size Certificate of pharmaceutical product Pre-registration analysis Local Technical Representative c. GMP report by PPB 37 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Common Pitfalls: Evaluation • BE tests and batch numbers of product used • Manufacturing processes of both API and FPP and process controls, validation, and justification • Characterization of API including isomers. • Stability studies on API and FPP • Choice of comparator for BE studies 38 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Variations(1) • Review of guidelines underway • may involve administrative and/or more substantial changes • Considered per change, per product • For a variation involving revision of the Summary of Product Characteristics (Sm. PC), labelling and package leaflet/insert, this is considered as part of the variation. 39 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Variations (2) • Minor Changes • Major Changes • Change in the manufacturing process of the API • Change in the composition of the finished product • Change of immediate packaging of the product • Changes Which May Require A New Application: • Changes to the API (±type, quantity) • Changes to the pharmaceutical form/dosage form • Changes in the route of administration 40 www. pharmacyboardkenya. org
Pharmacy and Poisons Board Finally! • The dossier submitted must conform to the requirements set out in the current PPB guidelines. • No alteration shall be made on the application form 41 www. pharmacyboardkenya. org
Pharmacy and Poisons Board THANK YOU! 42 www. pharmacyboardkenya. org
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