Presentation on theme: "The New Kenyan Drug Regulation Guidelines"— Presentation transcript:
1 The New Kenyan Drug Regulation Guidelines Mwavali HumphreysPharmacy and Poisons Board, KenyaSAPRAA, 17-18th November 2011
2 About pharmacy and poisons board (ppb) BackgroundVision and MissionOrganogramServicesClients and StakeholdersAchievementsAbout pharmacy and poisons board (ppb)
3 PHARMACY AND POISONS BOARD THE PHARMACY AND POISONS BOARD REPUBLIC OF KENYAMINISTRY OF MEDICAL SERVICESPHARMACY AND POISONS BOARDEnsuring the provision of quality, safe and efficacious pharmaceutical products and services.THE PHARMACY AND POISONS BOARD
4 BACKGROUND ... 1Established as a Regulatory Authority under the Pharmacy and Poisons Act, Chapter 244 of the Laws of KenyaCommenced operation on the 1st of May 1957.
5 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.
6 BACKGROUND ... 3The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.
7 MISSION OF THE BOARDTo improve the quality of life of Kenyans by ensuring provision of good quality, safe and efficacious pharmaceutical products and services in Kenya
8 VISION OF THE BOARDTo be global leader in the control and regulation of drugs (food, chemicals) poisons and practice of pharmacy
10 Membership of the Pharmacy and Poisons Board … 1 The Board of Directors consists of the following:Chairman -Director of Medical Services, GoK.Registrar - Chief Pharmacist, GoKDirector of Veterinary Services
11 Membership of the Pharmacy and Poisons Board … 2 Four Pharmacists nominated by the Pharmaceutical Society of Kenya of whom one represents:The Civil ServiceCommunity PharmacyThe Pharmaceutical Industry
12 Membership of the Pharmacy and Poisons Board … 3 A representative from the Faculty of Pharmacy U. o. NA Pharmaceutical Technologist
13 PHARMACY AND POISONS BOARD ORGANISATION MINISTRY OF MEDICAL SERVICESBOARD OF DIRECTORS(DR. KOSKEI)REGISTRARDEPUTY REGISTRAR(DR. SIYOI)HEAD LEGAL AFFAIRS(DR. YANO)HEAD TRADE AFFAIRS(DR. KIMATHI)HEAD, QUALITY ASSURANCE (DR. KIMATU)BUSINESS SUPPORT DIRECTORATE (DR. OCHIENG)(MR. MURIMI)ICT(MS. ODONGO)HRM/EXEC. SEC.(MR. MUGUNI)FINANCEPROCUREMENT(MR. TSUMA)PRODUCT EVALUATION & REGISTRATION DIRECTORATE(DR. NJUE)PHARMACOVIGILANCE & MEDICINES INFORMATION(DR. JAYESH)HERBS & MEDICAL DEVICES(DR. SIFUMA)DRUG EVALUATION & REGISTRATION(DR. MUNYOROKU)EVALUTION AND REGISTRATION VETERINARY SECTION(DR. NZUMBU)PHARMACY PRACTICE & REGULATION DIRECTORATE(DR. MOHAMED)PHARMACY PRACTICE SECTION(DR. GACHOKI)REGISTRATION & ENROLMENT SECTION(**)(DR. INYANGALA)C.P.D.INSPECTORATE & SURVEILLANCE DIRECTORATE(DR. WASIKE)GOOD MANUFACTURING PRACTICEGOOD DISTRIBUTION PRACTICE(DR. OWUOR)PORTS OF ENTRY(MR. KIPTOO)PHARMACY AND POISONS BOARD ORGANISATION
14 CORE VALUES ...1Highest Professional & ethical practices.Honesty & integrityFairness & equityDiligence and excellenceEfficacy and effectiveness
15 CORE VALUES ...26. Transparency & accountability 7. Innovativeness/creativity and continuous improvement 8. Teamwork, networking and partnership with other organizations
16 OUR SERVICES ...1 Product Evaluation and Registration Evaluation of Applications for Advertisements of Medicines and Medical DevicesEnsuring Good Manufacturing Practice (GMP)Pharmaco-vigilance and Post-Market Surveillance
17 OUR SERVICES …2 Registration of Pharmacists Enrolment of Pharmaceutical TechnologistsIssuance of Annual Practice LicensesIssuance of Annual Permits for Pharmaceutical RepresentativesRegistration of Pharmaceutical Premises/Outlets
18 OUR SERVICES …3Approval of Institutions Offering Pharmacy Training ProgramsApproval of Pharmaceutical Imports and ExportsDocumentation and Information Services on Medicines and Pharmacy PracticePublic relations services
19 OUR CLIENTS ...1 Pharmaceutical Manufacturing Companies Pharmaceutical Importers, Exporters, Distributors, Wholesalers and RetailersHospitals and other Healthcare ProvidersResearchers
20 OUR CLIENTS ...2 Pharmacy Practitioners Universities and Colleges Pharmaceutical Service ProvidersSuppliersConsumers
21 STAKEHOLDERS ...1 Government Ministries and Departments Development PartnersPharmaceutical Society of KenyaKenya Pharmaceutical AssociationKenya Association of Pharmaceutical Industry (KAPI)
22 STAKEHOLDERS ...2 External Quality Assurance Agencies Research OrganizationsIndustry and Private SectorPharmacy StudentsConsumersThe Public
23 REFORMS AND ACHIEVEMENTS Regional and International CollaborationTraining of Health Care Providers in Pharmaco-vigilance and Post Market Surveillance SystemSecured supplyUse of cutting edge anti-counterfeiting technologies
24 REFORMS AND ACHIEVEMENTS Enhanced capacity of InspectorateThe Anti-Counterfeit Bill of 2008Immediate Destruction of Expired DrugsGood Manufacturing PracticeDevelopment of New Regulation
25 New ppb drug registration guidelines CTD Guidelines-What is new?General RequirementsFormatRegistration ProcessCommon PitfallsVariationsNew ppb drug registration guidelines
26 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.
27 General Requirements (1) Complete application formOne hard copyOne soft copy (CDRom) with full dossier in Portable Document Format, (PDF) and MS-Word document for Modules 1 and 2, adequately cross-referenced to the dossierDO NOT FILL the blue areas indicated: ‘for PPB Official Use Only!’
28 General Requirements (2) Language: English and legible (a copy in the original language and a full translation)A4 and 80g/m paper with readily readable letters of at least 12 font sizesEvery page should be numbered sequentiallyState the exact location (Annex number) of any appended documents in the relevant sections
29 General Requirements (3) All parts must be bound and arranged sequentiallyThe left-hand margin should be sufficiently largeThick and hard enough not to collapse in standing positionFor references in compendia, text books or standard publications, provide reprints or authenticated copies of relevant pages
30 General Requirements(4) Three (3) samples of the smallest commercial pack(s) from one batchCurrent GMP certificate for site of manufacture from PPBPre-registration analysis (PPB approved lab)Registration status in country of origin
31 Format(1)Module 1. Administrative Information and Prescribing InformationModule 2. Chemical, Pharmaceutical, Non-clinical And Clinical Overviews And Summaries2.1. Overall Table Of Contents Of Modules 2, 3, 4, And 52.2. Introduction2.3. Overall Quality SummaryOverview API(s)Overview Of Finished Pharmaceutical Product(s) [FPP(s)]
32 Format(2) Module 3. Chemical-pharmaceutical Documentation 3.1. Table of contents of Module 33.2. Body of dataParticulars of active pharmaceutical ingredient(s) [FPP(s)]Particulars of finished pharmaceutical product(s) [FPP(s)]
33 Format(3) Module 4. Non-clinical Study Reports 4.1. Table of contents of Module 44.2. Study reports4.3. Literature references
34 Format(4) Module 5: Clinical Study Reports 5.1. New chemical entities only5.2. Interchangeability of generic drugs – (Generic drug applications only)5.3. Safety and Residues Documentation (for veterinary products only)
35 Registration Process: Screening RECEIVING THE CTD DOSSIER, SAMPLES AND PAYMENT OF FEESSCREENING THE CTD DOSSIER (EVALUATOR)REJECTED AND RETURNED TO OWNERACCEPT AND ALLOCATE A CTD NUMBER USING SIAMED STORE THE DOCUMENT, SAMPLES AND RECORD (SIAMED)
36 Registration process: Evaluation FIRST EVALUATION (REPORT)SECOND EVALUATION (REPORT)RECOMMENDED FOR REGISTRATION/ QUERIES RAISED/ REJECTED (OPTION OF APPEAL)REGISTRATION (PRACTICE COMMITTEE)GAZZETMENT
37 Common Pitfalls: Screening FormatAddress of applicantTrade name and packaging of product.Product pack sizeCertificate of pharmaceutical productPre-registration analysisLocal Technical RepresentativecGMP report by PPB
38 Common Pitfalls: Evaluation BE tests and batch numbers of product usedManufacturing processes of both API and FPP and process controls, validation, and justificationCharacterization of API including isomers.Stability studies on API and FPPChoice of comparator for BE studies
39 Variations(1) Review of guidelines underway may involve administrative and/or more substantial changesConsidered per change, per productFor a variation involving revision of the Summary of Product Characteristics (SmPC), labelling and package leaflet/insert, this is considered as part of the variation.
40 Variations (2) Minor Changes Major Changes Change in the manufacturing process of the APIChange in the composition of the finished productChange of immediate packaging of the productChanges Which May Require A New Application:Changes to the API (±type, quantity)Changes to the pharmaceutical form/dosage formChanges in the route of administration
41 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