- All Concerned Industry/ Stakeholders
- Public Hearing on New Schedule of Fees and Charges and Rationalization of the Services of the Food and Drug Administration (FDA)
Day Time Center Code 15 July 2015 9:00 - 11:00 AM CCRR 1:00 - 3:00 PM CDRR 16 July 2015 9:00 - 11:00 AM CDRRHR 1:00 - 3:00 PM CFRR
- 3rd Floor, Audio-Visual Room, Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
I. BACKGROUND AND RATIONALE
Enshrined in Section 12, Article XIII on Health of the 1987 Philippine Constitution is the responsibility of the State to establish and maintain an effective food and drug regulatory system and to undertake research responsive to the country's health needs and problems. Consistent with the national policy, the Congress of the Philippines passed three landmark legislations, namely Republic Act (RA) No. 9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008), Republic Act No. 9711, (Food and Drug Administration Act of 2009) and Republic Act 10611 (Food Safety Act of 2013), to ensure protection of public health and welfare.
Section 31 of R.A. No. 9502, consistent with Section 18 of RA No. 9711, authorizes the Food and Drug Administration (FDA) to retain all fees, fines, royalties and other charges under a Special Regulatory Fund and to use them as follows: operations, including upgrading of its facilities, equipment outlay, human resource development and expansion; acquisition of the appropriate office space, purchase of laboratory equipment and motor vehicles; upgrading of its current facilities and equipment and maintenance; to fund operating expenses of the central office laboratory divisions and satellite laboratories, as well as other activities or services of the FDA in the performance of its mandate. Furthermore, R.A. No. 9711 stated that the FDA shall cease to be allocated its budget under the General Appropriations Act after it has established itself to be fiscally sustainable.
Presently, the income of FDA, net of government subsidy, is not sufficient to support its operations. Thus, the FDA needs to improve its financial resources and attain fiscal stability by increasing its fees and charges based on the corresponding direct and indirect costs of the services rendered by the FDA. Section 54 (l), Chapter 12, Book IV of the Executive Order No. 292 or the Administrative Code of 1987 provides the legal background that heads of bureaus, offices or agencies, upon approval of the concerned department head shall have the continuing authority to revise their rates of fees and charges. Determination of new fees is based on the DOF-DBM-NEDA Joint Circular No. 1 series 2013, also known as the Implementing Rules and Regulation of Administrative Order No. 31 series 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates, and imposition of New Fees and Charge where direct and indirect cost has been the main basis.
It is the intention of the FDA that the restructuring of fees at current rates is reasonable to ensure continuous regulatory compliance of the industry sectors at the local, national and international levels. All health products that are manufactured, imported and exported by the country should meet technical requirements for safety, efficacy or quality, based on international standards. A fully transparent, formal, predictable and reliable regulatory process or system is only possible when the FDA has already attained a stable and sustainable financial system.
Consultation on the Strengthening of the Pharmacy Workforce through Professionalization of Pharmacy Assistants
A key aspect in achieving definite outcomes related to improving a patient's Quality of Life (QOL) is pharmaceutical care. In the pharmaceutical care process, the pharmacists cooperates with his/her patient and with other professional in designing, implementing, and monitoring a therapeutic outcomes for the patient. Further, in pharmaceutical care, the highest quality of care is achieved when the right medicine (safe, effective, and of high quality) is provided to the right patient, at the right dose, in the right route at the right time and with the right information.
In this context, the Food and Drug Administration (FDA) in coordination with the Technical Education and Skills Development Authority (TESDA) is looking at the professionalization of the pharmacy support (e.g. Pharmacy assistants and Pharmacy technicians), with the overall goal of maximizing therapeutic outcomes from drug products through the delivery of quality pharmacy services. A consultative meeting will be hosted by the FDA. The particulars are as follows.
|Venue||:||3rd Floor, Audio-Visual Room, Annex Bldg,
FDA Compound, Civic Drive, Filinvest Corporate City,
Alabang, Muntinlupa City (Luzon)
|Date||:||21 July 2015 (Tuesday)|
|Time||:||9:00 AM - 11:00 AM|
KAPIHAN AT TALAKAYAN: Dialogue with the Secretary of Health and Director General of the Food and Drug Administration (FDA) on Regulatory Matters
WHO : All Concerned Industry Association
WHAT : KAPIHAN AT TALAKAYAN: Dialogue with the Secretary of Health and Director General of the Food and Drug Administration (FDA) on Regulatory Matter
|06 July 2015||9:00 - 11:00 AM||CCRR|
|1:00 - 3:00 PM||CDRR|
|14 July 2015||1:00 - 3:00 PM||CDRRHR|
|3:00 – 5:00 PM||CFRR|
WHERE : 3rd Floor, Audio-Visual Room, Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
|Subject||KAPIHAN: Center Code|
|Body of Email|
|Name of Association|
|Name of Participant/s||Last Name, First Name MI.|