1. Traditionally-Used Herbal Medicines, Herbal Medicines, Household Remedies, and Over-the-Counter Preparations (TM/HM/HR/OTC) Unit-Registration Section, Licensing and Registration Division (LRD)
2. Standards Development and Advocacy (SDA) Section-Product Research and Standards Development Division (PRSDD)
3. Center for Drug Regulation and Research, Food and Drug Administration (FDA) Philippines, Department of Health, Republic of the Philippines
Project ObjectivesThe Philippine Health Sector Reform Contract (PHSRC), supports the national sector program on UHC within the sector wide approach under government leadership. Particular consideration will be given to critical challenges to increase the capacity and commitment of local governments to deliver health services and to ensure effective and sustainable implementation of health reforms at the local level, especially for the poor. In general, the PHSRC and its TA program will focus on the reforms addressing evidence based policy, health financing, strengthening local health systems, the regulation of drugs and health technology, and health human resources
Job DescriptionThe Food and Drug Administration (FDA) is the regulatory authority under the Department of Health (DOH) mandated to ensure the safety, efficacy, and quality of health products, including drug products. The center for Drug Regulation and Research (CDRR), a center under FDA, regulates the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of drugs (including veterinary medicine, biologicals, and radiopharmaceuticals) and, when appropriate, certify batches of antibiotic and antibiotic preparations.
Over-the-Counter (OTC) Drugs are drug products that can be dispensed even with a written order or prescription of a licensed physician or dentist for human use, for the symptomatic relief of minor or self-limiting ailments. In 2000, the Department of Health (DOH) issued Administrative Order No. 23-C series of 2000 which served as the guidelines for OTC drugs to promote greater accessibility while ensuring public safety.
Household Remedies (HR) are preparations containing drug substances of common or ordinary use to relieve common physical ailments, and can be dispensed over-the counter. These products have no history of or recognized adverse reaction after being marketed and used for at least twenty (20) years according to its indication.
Given the delays in the review and evaluation of OTCs and HR applications, and the similarities in the regulation of these two product types, and listing process in certain regulatory authorities, there is a need to review the existing policies, systems, and procedures on the registration of these products.
The Overall Objective of the assignment is to provide technical assistance to FDA Philippines, specifically CDRR in the review and revision of the existing policies, systems, and procedures for the regulation of OTC and HR products.
Specific Objectives1. To review the existing registration policies for registration and the equivalent systems in place, including:
a) Bases for classifying as prescription, OTC, or HR and the equivalent supporting documents
b) Registration requirements
c) Internal evaluation processes and the corresponding evaluation forms
2. Identify issues, gaps, and bottlenecks with the current policies, systems, and procedures;
3. To deliver introductory courses in a classroom-type lectures/presentations composed of:
a) Existing policies, systems, and procedures for the registration/listing of these products from the benchmark countries such as Canada, EU, UK and Sweden, USA, Japan, Australia
b) Country experience on the registration of OTCs
4. To demonstrate actual evaluation of an OTC or HR application for registration or listing, as conducted by benchmark countries which will serve as practical application of the principles and concepts discussed by the expert;
5. Come up with concrete recommendations for improvement with the current system by preparing guidelines, process flow charts, internal procedures, and forms for evaluation
Expert ProfileThe professional qualifications of the Expert should be as follows:
To obtain more information or to submit your CV, please contact:
Frederica Andriamanantena, Technical Assistance Coordination and Quality Assurance Officer at recruitment.philippines@epos.de, with subject title: FDA OTC Expert
EPOS Health Management, headquartered in Germany, was founded in 1985 as an independent worldwide provider of consulting services in the health sector. Today EPOS is the German market leader in donor-financed health care consulting.
We specialise in planning, management, and implementation as well as monitoring and evaluation of projects, services and programmes in the health sector in developing and threshold countries. Our Quality Management System is regularly audited and certified according to ISO 9001:2008 standards.
Following a participatory approach, EPOS has implemented more than 400 health projects in nearly 75 countries over the last 25 years in the areas of:
Being part of the GOPA Group, EPOS belongs to one of the strongest consulting groups in Europe.
epos Beratungsgesellschaft, an independent healthcare consulting firm, is a sister-company within the EPOS group.
