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The New Kenyan Drug Regulation Guidelines

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Presentation on theme: "The New Kenyan Drug Regulation Guidelines"— Presentation transcript:

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

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

3 PHARMACY AND POISONS BOARD THE 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

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
MINISTRY OF MEDICAL SERVICES BOARD OF DIRECTORS (DR. KOSKEI) REGISTRAR DEPUTY 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) FINANCE PROCUREMENT (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 PRACTICE GOOD DISTRIBUTION PRACTICE (DR. OWUOR) PORTS OF ENTRY (MR. KIPTOO) 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 New ppb drug registration guidelines
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 Overview 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 3 3.2. Body of data Particulars 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 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) REJECTED AND RETURNED TO OWNER ACCEPT 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
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 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 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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