E-DRUG: Position: Short term expert for Philippines FDA
----------------------------------------------------------------------------
Dear colleagues,
The Philippine Health Sector Reform Contract (PHSRC), supports the national sector program on UHC within the sector wide approach under government leadership. The 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.
We are looking for a short-term expert to provide technical assistance to FDA Philippines, in the review and revision of the existing policies, systems, and procedures for the regulation of Over-the-Counter (OTC) Drugs and Household Remedies (HR) products.
Please find hereafter the job description and details for applying: http://www.epos.de/jobs/job-opportunities/drug-administration-registration-over-counter-products-philippines
Best regards,
Frederica ANDRIAMANANTENA
EU PHILIPPINES HEALTH SECTOR REFORM CONTRACT
Department of Health, BIHC, Bldg 3, Manila
JOB DESCRIPTION
The 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 radio-pharmaceuticals) 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 OBJECTIVES
1. 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 PROFILE
The professional qualifications of the Expert should be as follows:
--At least a Master's degree or equivalent in the relevant field and with a minimum of 10 years of relevant work experience for senior experts gained in at least three developing countries and at least five years outside of the Philippines. Relevant experience in South East Asia is an asset;
--Expert in OTC registration/listing process or function as a DRA Officer in countries where an OTC products registration/listing system is already established;
--Minimum of two years experience in OTC registration/listing processes.
--Previous on job training of FDA registration technical staff;
--Fluency in English and Microsoft office applications
CONTACT
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
"Andriamanantena, Frederica" <Frederica.Andriamanantena@epos.de>