FDA Philippines hosted the study tour of delegates from Mongolia, consisting of five Members of Parliament and four senior officialsof the Ministry of Health (MOH) on 01-04 April 2014. The study tour aimedto give first-hand exposure on how the Philippines established its Food and Drug Administration, how it set up its organization and management system, and how it developed its regulatory and enforcement system. The visit was intended to help the Mongolian legislators in their planned revision of their Mongolian Medicines Law.
The Center for Drug Regulation and Research (CDRR) has committed to process product registration applications (initial and renewal) within one hundred eighty (180) working days as stipulated in Republic Act 3720. However, due to the large volume of registration applications we received on the last week of June 2013 (26 and 27 June) and first week of July 2013 (02 and 03 July) the CDRR may not be able to evaluate the applications within the committed turn-around time. As such, you may experience delays in the processing of your applications given the limited manpower complement of the Center. Applicant companies shall be duly notified on the status of their registration applications.
Last September 11, 2013, the Food and Drug Administration (FDA) released a press statement that summarizes what FDA has done so far with regards to regulations of human cells, tissues, and cellular and tissue-based products (HCT/Ps). All issuances are in the FDA website for reference.
Pursuant to the Department of Health (DOH) Administrative Order (AO) 2013 – 0012 which was released just last March 18 2013, the DOH-Bureau of Health Facilities and Services (BHFS) and DOH-Food and Drug Administration (FDA) are continuously collaborating in accrediting health facilities that engage in HCT/P laboratory and therapeutic activities or services. As of September 24, 2013, 51 facilities already applied for accreditation, and 11 of these are already inspected by BHFS. Both FDA and BHFS shall continue to review the minimum standards for personnel qualifications, physical facilities, equipment and supplies, work environment and proper record keeping in each facility that will provide readily available information for each donor, patient, and procedures on HCT/Ps. Out of the 14 product applications that FDA has received, as of September 24, 2013, ten (10) are autologous products while others are asked to send additional documents needed to be properly evaluated. Nine (9) out of the 14 product applications are strongly recommended to undergo clinical trial because their use as stated are outside of the initial three standard health care generally recognized by the FDA.
The FDA received its Anti-Red Tape Act (ARTA) Report Card covering the survey period of September 16, 18 and 19, 2013 from Ms. Lydia Alba-Castillo, Director of the Civil Service Commission (CSC). In the area of Compliance with ARTA Provisions. FDA received a numerical rating of 89.49%, while in the area of Overall Client Satisfaction, the FDA received a numerical rating of 80.74%. The Final Numerical Rating received by the FDA was 84.83%, equivalent to a descriptive rating of GOOD.
Last April 24, to 26, 2013, the FDA received a Final Numerical Rating of only 70.57%. It scored 76.32% in the area of Compliance with ARTA Provisions and 65.52% for the Overall Client Satisfaction.
The FDA improved by 14.26% in a span of around 4 months. The vast improvement can be attributed mainly to FDA compliance in providing Public Assistance and Complaints Desk (PACD). From the FDA lobby, where all applications were received by the Centers for food, drugs and cosmetics, the FDA is now able to manage all business transactions inside the spacious air-conditioned Public Assistance, Information and Receiving (PAIR) Unit, with provisions of comfortable seats, drinking water, and cable TV. The FDA was given a score of only 17.16% for PACD last April. After four months, the FDA got a score of 82.84%.
Last April, the FDA was in the midst of undergoing major transition from an agency composed of divisions per regulatory activities to an agency of centers for major health product categories.
Another area where FDA improved was in providing basic facilities (88.24%) and service quality (79.07%),
The Center for Drug Regulation and Research (CDRR) considers our industry stakeholders as partners in providing for and ensuring the safety of the public by providing only safe, efficacious and quality medicines. As such, we want to create a positive experience for all businesses interacting with us. In view to this, may we invite you to the CDRR Forum (an expanded "Kapihan at Talakayan sa FDA" event) on 25 September 2013, 9:00-11:00 am, at the Audio Visual Room, 3rd Floor, FDA Annex Building. The objectives of the activity is to share with you some regulatory reforms happening at the CDRR and to gather your insights and experiences in the registration of pharmaceutical products and licensing of establishments as well as your suggestions for an enhanced business and regulatory processes.