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The New Kenyan Drug Regulation Guidelines

The New Kenyan Drug Regulation Guidelines. Mwavali Humphreys Pharmacy and Poisons Board, Kenya SAPRAA, 17-18 th November 2011. Background Vision and Mission Organogram Services Clients and Stakeholders Achievements. About pharmacy and poisons board (ppb). REPUBLIC OF KENYA.

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The New Kenyan Drug Regulation Guidelines

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  1. The New Kenyan Drug Regulation Guidelines Mwavali Humphreys Pharmacy and Poisons Board, Kenya SAPRAA, 17-18th November 2011

  2. Background Vision and Mission Organogram Services Clients and Stakeholders Achievements About pharmacy and poisons board (ppb)

  3. 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

  4. BACKGROUND ... 1 • Established as a Regulatory Authority under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya • Commenced 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 ... 3 • The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.

  7. 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

  8. VISION OF THE BOARD To be global leader in the control and regulation of drugs (food, chemicals) poisons and practice of pharmacy

  9. OUR HEAD OFFICE

  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, GoK • Director 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 Service • Community Pharmacy • The Pharmaceutical Industry

  12. Membership of the Pharmacy and Poisons Board … 3 • A representative from the Faculty of Pharmacy U. o. N • A Pharmaceutical Technologist

  13. PHARMACY AND POISONS BOARD ORGANISATION

  14. CORE VALUES ...1 • Highest Professional & ethical practices. • Honesty & integrity • Fairness & equity • Diligence and excellence • Efficacy and effectiveness

  15. CORE VALUES ...2 6. 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 Devices • Ensuring Good Manufacturing Practice (GMP) • Pharmaco-vigilance and Post-Market Surveillance

  17. 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

  18. 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

  19. OUR CLIENTS ...1 • Pharmaceutical Manufacturing Companies • Pharmaceutical Importers, Exporters, Distributors, Wholesalers and Retailers • Hospitals and other Healthcare Providers • Researchers

  20. OUR CLIENTS ...2 • Pharmacy Practitioners • Universities and Colleges • Pharmaceutical Service Providers • Suppliers • Consumers

  21. STAKEHOLDERS ...1 • Government Ministries and Departments • Development Partners • Pharmaceutical Society of Kenya • Kenya Pharmaceutical Association • Kenya Association of Pharmaceutical Industry (KAPI)

  22. STAKEHOLDERS ...2 • External Quality Assurance Agencies • Research Organizations • Industry and Private Sector • Pharmacy Students • Consumers • The Public

  23. REFORMS AND ACHIEVEMENTS • Regional and International Collaboration • Training of Health Care Providers in Pharmaco-vigilance and Post Market Surveillance System • Secured supply • Use of cutting edge anti-counterfeiting technologies

  24. REFORMS AND ACHIEVEMENTS • Enhanced capacity of Inspectorate • The Anti-Counterfeit Bill of 2008 • Immediate Destruction of Expired Drugs • Good Manufacturing Practice • Development of New Regulation

  25. CTD Guidelines-What is new? General Requirements Format Registration Process Common Pitfalls Variations New 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 form • One hard copy • One 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 dossier • DO 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 sizes • Every page should be numbered sequentially • State the exact location (Annex number) of any appended documents in the relevant sections

  29. General Requirements (3) • All parts must be bound and 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

  30. 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

  31. 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)]

  32. 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)]

  33. Format(3) • Module 4. Non-clinical Study Reports 4.1. Table of contents of Module 4 4.2. Study reports 4.3. Literature references

  34. 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)

  35. Registration Process: Screening RECEIVING THE CTD DOSSIER, SAMPLES AND PAYMENT OF FEES SCREENING THE CTD DOSSIER (EVALUATOR) ACCEPT AND ALLOCATE A CTD NUMBER USING SIAMED  REJECTED AND RETURNED TO OWNER STORE THE DOCUMENT, SAMPLES AND RECORD (SIAMED)

  36. Registration process: Evaluation

  37. 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 • cGMP report by PPB

  38. 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

  39. Variations(1) • Review of guidelines underway • may involve administrative and/or more substantial changes • Considered per change, per product • For a variation involvingrevision 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 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

  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

  42. THANK YOU!

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