ISSUE NO.1 OCT-DEC 2013 + Product Evaluation and Registration + Inspectorate, Surveillance and Enforcement PPB Newsletter Business Support Ensuring Safety, Quality and Efficacy of Medicines & Practice of Pharmacy + + Medicines Information & Pharmacovigilance + Pharmaceutical Manufacturing Services + Pharmacy Practice & Training Ppb Marks Milestone with the Launch of Stakeholder’s E-Portal To Promote Ease of Doing Business Pg. 8 Inside this edition Word from the Registrar ........................................ 2 Word from Deputy Registrar ..................................... 3 Word from the Editors .............................................. 4 Directorates & their tasks ...................................... 5 Medicine Regulation Harmonisation .................... 7 Setting pace in Pharmacovigilance ....................... 10 PPB at Mombasa ASK show .................................... 11 The PPB Pictorial ....................................................... 12 Regional Heads Consultative Meeting ............ 14 MINISTRY OF HEALTH Colleges Licensed to offer Pharmacy courses .... 14 Pharmacy & Poisons Board 1 Dr. Kipkerich Koskei Registrar From the Registrar’s Desk Thank you all for making this a successful year wish to appreciate all our members of staff at the Pharmacy and Poisons Board for the dedication you have shown this past year.Days have turned into weeks and weeks into months and now we are about to say kwaheri to 2013. We all anticipated that we will find ourselves here at the be- Iginning of the year. Our plans and programmes remain on course in spite of notable challenges here and there. We have made some incredible milestones this year. Notably, our efforts to digitise our systems in line with the country’s Vision 2030, and in an ef- fort to offer efficient service to our customers, we launched two major web based tools; the Pharmacovigilance Electronic Reporting System and the Stakeholders’ e-Portal. These tools will greatly enhance service delivery be- sides affording The Board real time data management for efficient decision making. Going forward we shall endeavour to deploy more new technologies where necessary and empower our staff with skills to efficiently utilise them. I also wish to take this opportunity to thank you all for being patient with our limited space at the Headquarters. We regret that this has often been discomforting for both our staff and customers. This problem is soon going to come to an end. As you may be well aware construction of our new building is nearing completion and will be ready for occupying in the coming year.We hope that with the new premises, the problem of crowding will be sorted out once and for all as indeed other situations associated with crowding. I know that it is often not objective for anyone to judge their own work. But any service that does not bring some form of satisfaction to the service giver must often be wanting in one way or another. This is because the rea- son an opportunity comes to you is so that you may make a difference in the life of someone else. All PPB members of staff have an obligation to do just that. Finally, thank you all for the good year it has been. Without you not much we are celebrating today would have been achieved. All the little efforts you made have culminated in the successes that we can see today. As we say kwaheri to 2013, it is my hope that we shall pick it up from there in the coming year and make 2014 an even better year for all. Merry Christmas and a prosperous New Year Dr.Kipkerich Koskei Registrar 2 Dr. Fred M. Siyoi Deputy Registrar From Deputy Registrar’s Desk Let’s all embrace the new PR department and the Newsletter am glad to share my few thoughts on this new platform courtesy of our Department of Public Relations. It gives me joy to note that this is the inaugural edition of the PPB Newsletter coming only a few months after the department came into being. The department was created recently Ito spearhead our public communication strategy and to enhance the image of the organisation. Public relations is a very important service for any organisation. Most organisations rise and fall on the strength of their image. Though this has been a yearning for PPB for a while now, it was not until this August that the department was formed and we are glad they are already taking their baby steps.This goes to say that the organisation as a whole is growing. Let me start by congratulating those in the department for coming up with this idea and moving so fast to implement it. This is commendable. It is my hope that you will keep up with the tempo with which you have started. I also hope that this tool will broaden and enhance our communication with our countrywide networks as well as generate important public awareness messages about The Board and our services. The management will give you all the necessary support you will require in that regard. I would like to also encourage all the departments to come on board and participate in making this a success. A lot of the good work you do may never be appreciated by the people you serve due the reason that they may not even know about it. But when you have it documented here and passed around it acts as a good testimony to your efforts and dedication. Furthermore, PPB is like a family. All of us form an integral part of that family and this is not by accident. The success of the family depends on the input of every one of us. We all celebrate when one of us has achieved some- thing for the family. Likewise we all bear the collective consequences of the failure of one of us either directly or indirectly. By the fact that we are all here, it is a call to rise to the occasion and bring pride to the family by play- ing our respective roles. Finally I take this opportunity to wish you all a Merry Christmas and a happy New Year. Dr. F. M. Siyoi Deputy Registrar 3 Sophia Waihenya & Sheila Muriithi From the Editors’ Desk elcome to the inaugural edition of the Editors Pharmacy and Poisons Board Newsletter. Sophie Waihenya This has been long in coming. And like all Sheila Muriithi things new, there are those who will find it Wexciting and there are those who will wish one extra Editorial Board thing or another was done on this edition. Whatever Dr. Ronald Inyangala the case may be we are delighted to present to you Dr. Edward Abwao the newest kid on the block with the hope that we Mr. Joshua Plekwa shall be able to grow it together from here. Indeed Sophie Waihenya as the Chinese saying goes, the journey of a thousand Sheila Muriithi miles starts with the first step. Dorine Odongo The board has been in the news lately. Much of what we saw in the media was very discouraging. Yet there have also been great achievements these last Contibutors few months. In April this year The Board launched the Dr. James Owuor Pharmacovigilance Electronic Reporting System and in Dr. Felistus Yano this October we launched The Stakeholder’s e-Portal. Mr. George Muthuri The October launch is the highlight of this edition. Looking back through the months this year a num- Photography ber of important activities have also taken place. We Mr. John Komen highlight key among those events. You will read about the Mombasa ASK show experience as well as regional Design and Layout heads consultative meeting. Sophie Waihenya We have also featured prominently the achieve- Sheila Muriithi ments of the pharmacovigilance department. Some of the key activities of the department have come up for The PPB Newsletter is a qaurterly mention in international forums. We definitely look publication of The Department of forward for more in the coming days. Public Relations of The Pharmacy and In keeping with the spirit of the East African Com- Poisons Board. It is designed to act munity PPB and other regulatory bodies in the member as a tool of communication, docu- countries are seeking to harmonise medicine regula- menting and diseminating important tion for the EAC. The project is aimed at increasing news and information to the staff and access for safe, efficacious and good quality essential stakeholders of The Board. medicines in the member states. This edition highlights some of the key milestones of the project that has Department of Public Relations, been praised as the first on the African continent. Pharmacy and Poisons Board, Finally, the Directorate of Pharmacy Practice and Lenana Road Regulation of Training has published inside the pages of P.O. Box 27663-00506 Nairobi. this edition a full list of colleges licensed to offer phar- Tel: +254-020- 3562107/2716905/6 macy courses in the country. We encourage all to take Fax: +254-020- 2713431/2713409 the opportunity and contribute articles for publication Email: [email protected] in this newsletter in future. We hope to do this every Web: www.pharmacyboardkenya.org quarter of the year. For more, kindly turn the pages and read on. 4 PPB Directorates & their tasks he Pharmacy and Poisons Board is the Drug Regulatory Author- ity established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and Tpoisons. There are 6 Directorates at PPB that ensure that the Board’s Mandate is carried out efficiently. These Directorates are: 1. Produst Evaluation and Registration Roles • Receipt of new applications for medicines Registrations i.e. Human, Vetinary, Herbal • Listing of food supplements and Medical Devices • Evaluation of dossiers for medicines registration • Advise to clients on matters of medicine registration • Evaluation of ammendments to registered products • Retention (annually) for the registered products • Development of medicines, medical devices and food suppliement guidelines Dr.