Establishment of Web-enabled (Online) Open Source Electronic Software System for product registration, Ministry of Health, Cambodia
Purpose of the Consultancy
The consultant/consulting firm will be required to develop an online (web-enabled) Open Source Electronic Software System for product registration at the Drug Registration Bureau, Department of Drugs, Food and Cosmetics, Ministry of Health, Kingdom of Cambodia. The online system will be designed to support product registration and information sharing activities in the bureau in addition to also facilitating data analysis and generation of reports. The consultant/consulting firm will work in conjunction with the WHO medicine registration consultant and the drug registration bureau to develop the system.
Terms of references for the WHO Short-term consultant include:
In close collaboration with Department of Drugs and Food, Ministry of Health and WHO Country Office in Cambodia:
- To conduct system analysis and design with the view of upgrading the current product registration system infrastructure and software.
- To design, develop and test an online open source interactive, software system (perform front-end and back-end programming) for product registration at Drug Registration Bureau using available web-technology.
- To train stakeholders and drug registration bureau staff to use, update and maintain the system developed.
- To provide technical knowledge and experience that will improve product registration operations at Drug Registration Bureau.
- To provide system technical support documentation (including manuals and source codes) in order to facilitate maintenance and future upgrade activities.
- To provide an application programming interface (API) for integration of the product registration system with the other Bureaus within DDF, national electronic single window and other regional national regulatory authorities.
- To provide two-year system maintenance and system sustainability strategy.
- To provide a consultancy report along with the manuals and source codes.
Systems User Requirement Specification (URS) for the registration system would be:
- Online Dashboard Module: The system should allow free web-based administrative panel for user accounts management with appropriate system security for web based software, login and two user interfaces [i.e. public (external applicants) and staff (internal)].
- Submission Module: The system should allow online electronic application submission by applicants seeking registration and renewal of their Products in Cambodia (Medicines, Vaccines, Health Supplements, Medical Devices etc.), brand name clearance system and manufacturer registration.
- Document management module: The system should allow simple online file uploads and downloads of applications data and reports in addition to electronic review and communication with clients.
- Project management module: The system should allow simple allocation and monitoring of tasks and tracking of application status.
- Data analytics module: The system should allow generation of system reports and simple data analysis.
Background
The Cambodian law and regulations on pharmaceuticals require that all medical commodities, whether imported or locally manufactured, must be registered prior to marketing. The Department of Drugs, Food and Cosmetics (DDF), Bureau of Registration (RB) is responsible for registration of medicines in Cambodia’s market. The Ministry of Health, Cambodia has committed to implement the Association of South East Asian Nations (ASEAN) Common Technical Dossier/ Requirements (ACTD/ ACTR) and thus there is need for the current existing registration process be aligned to allow assessors evaluate dossiers submitted using ACTD. In addition, the Ministry of Health also plans to introduce an online registration system through which applicants will submit online applications for marketing authorization.
WHO is providing technical assistance on medicines registration with the aim of developing a complete package of guidelines, tools and standard operating procedures (SOP) for all steps and processes of the marketing authorization of pharmaceutical products (medicines and vaccines). These guidelines, tools and SoPs will be used for the registration software.
The current registration pathway uses a computerized products registration system called the RACHA system, named after the agency that provided the funds to develop the registration system seven years ago, “Reproductive and Child Health Alliance – USAID”. RACHA is used to process product applications for the following product categories: pharmaceuticals (western medicines); medical device and reagents; traditional herbal medicines; and health supplements.
There are three (3) other databases (listed below) which are used for used to facilitate processing of product applications before the application data are entered into the computerized RACHA registration system:
- Brand name clearance;
- Registration of foreign manufacturers;
- Registration of health supporting products (recently only included as a product category for registration)
The consultant/consulting firm will be required to develop a software for pharmaceutical products registration (vaccines, traditional medicines) which will be linked with other regulatory databases.
Planned timelines (subject to confirmation)
Start date: 05/03/2018
End date: 30/03/2018
Work to be performed
- system analysis and design with the view of upgrading the current product registration system infrastructure and software
- design and development of the registration software
- costing of all required and optional components of the system, identifying all additional expenses (hardware and software) required to complete implementation.
- development of user manuals and guidelines
Method(s) to carry out the activity
Desk review, system analysis and design, training of end-users, development of user’s guide and manuals, consultation with users etc.
Output/s
The following deliverables of the assignment have been identified and will be tied to the release of funds.
- Prototype for product registration system shared and agreed.
- Product registration system and individual modules developed and operational.
- System User Testing of Modules: Non-Functional (Performance) Tests, User Acceptance Test (UAT), Piloting, Data Migration, Live use, Launch.
- Staff training, training modules, help systems and technical documents, and handover completed.
- Technical support manuals for the system which include documentation of the source code for support, maintenance and upgrades.
- System development status reports
Interested parties are required to submit:
- Scope of work statement with the description of software development methodology.
- Detailed project plan with relevant progress and payment milestones.
Technical Supervision
The selected Contractor will work on the supervision of:
Responsible Officer: Ms Lkhagvadorj Vanchinsuren
Email: lkhagvadorjv@who.int
Manager: Dr Kumanan Rasanathan
Email: rasanathank@who.int
Specific requirements
Qualifications required:
Education
Essential: A University degree or higher in Computer Science or related field from a recognized institution or international professional certificate in a software developing language.
Desirable: post- graduate degree or training on medicines supply chain management or drug information or medicines regulatory system
Experience
Essential: At least 5 years of proven professional and working experience in web technologies and information systems including their development and deployment. Extensive experience and knowledge in Secure Web portal development (Java, JavaScript), HTML5, XML, JWT security and Open Source Content Management Systems Software. Proven database programming with Oracle database.
Desirable: Developing and managing systems within a medicine regulatory authority in developing countries is highly desirable.
Skills / Technical skills and knowledge:
- Good understanding of the Linux hosting environment including but not limited to Apache Tomcat and Node.js
- Good understanding of Open Standards for Web Portal Development and implementation.
- Effective communication skills
- Excellent presentational skills.
- Ability to work effectively with national regulatory authority experts and stakeholders
Language requirements:
Essential: Fluent in English (writing, reading and speaking)
Competencies
- Good understanding of the Linux hosting environment including but not limited to Apache Tomcat and Node.js
- Good understanding of Open Standards for Web Portal Development and implementation.
Place of assignment
Department of Drugs and Food, Ministry of Health, Phnom Penh, Cambodia
Medical clearance
The selected Consultant will be expected to provide a medical certificate of fitness for work.
Travel
The Consultant is expected to travel according to the itinerary and estimated schedule below:
Travel dates/ Location:
From: XX/XX/20XX To: XX/XX/20XX/ XXXXXXXX
Purpose: Purpose of the mission
All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.
Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.
Interested should submit the following documents to wpkhmprocurement@who.int by 24 February 2017. Please use Tender Notice No. 68203 as subject to all submissions.
- Expression of Interest
- WHO personal history form or CV
Please note that the application may be closed before the indicated closing date if a sufficient number of applications are received. Only the successful candidates will be contacted