PRESS RELEASE
27 DECEMBER 2019

ASEAN Member States officially listed the Philippine Food and Drug Administration (FDA) under the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) for Medicinal Products during the 28th ASEAN Consultative Committee on Standards and Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) Meeting held on 19-20 December 2019 in Indonesia. The endorsement was agreed upon after the ASEAN Panel of Experts’ assessment of the FDA and successful establishment of the agency’s technical competency for inclusion in the register of accepted ASEAN Inspection Services.

As listed Inspection Service of the ASEAN MRA, the (1) FDA issued GMP Certificate for manufacturers of medicinal products, and (2) FDA GMP inspection reports shall be accepted by other listed National Regulatory Agencies under the ASEAN MRA on GMP.

Undersecretary of Health and FDA’s Officer-In-Charge (OIC) Director General, Rolando Enrique D. Domingo underscored the importance of the inclusion of the FDA in the ASEAN registry for both the industry and consumers. For the industry, the inclusion will result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection. The inclusion will also increase confidence in the quality of medicines for consumers, increase in reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines.

USec Domingo also emphasized that the successful inclusion “is a major step and contribution of the FDA to the government’s strategy to expand economic opportunities in industry and services through Trabaho at Negosyo as mandated by Philippine Development Plan (PDP) 2017-2022 anchored on a long-term vision or AmBisyon Natin 2040.”

The Philippines is the fifth country to be listed under the ASEAN MRA on GMP for Medicinal
Products after Singapore Health Sciences Authority, Malaysia National Pharmaceutical Regulatory Authority, Indonesia National Agency of Drug and Food Control and Thailand Food and Drug Administration.

Attachment:->FDA Included in the ASEAN Mutual Recognition Arrangement (MRA)

Attachment:-> FDA SYSTEM MAINTENANCE

Please be advised that the following draft issuances is now posted in the FDA Website for public comments:

1. Draft Administrative Order entitled “Amendment to Administrative Order No. 2016-0003 on the Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration”

2. Draft Administrative Order entitled “New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services, Amending Administrative Order No. 50 s. 2001, “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs”

Kindly leave your comments at the FDA Website or send it through email at [email protected] on or before 17 January 2020. Thank you very much.

Attachment:->FDA MEMORANDUM NO.2019-012-DRAFT FDA ISSUANCES FOR PUBLIC COMMENTS

To provide our employees the opportunity to participate in the FDA wide event on 13 December 2019, Friday, office work at the Food and Drug Action Center (FDAC) will be suspended from 12:00 noon onwards.

Applicants with confirmed schedule to appear on the said date will be accommodated during regular office hours.

For further inquiries, you may send us an email at [email protected].

Please be guided accordingly.

Thank you.

Attachment:->Half-Day Work Suspension at (FDAC) on 13 December 2019

The Toxicology Section of the Common Services Laboratory (CSL) shall be holding the aforementioned activity on 04 December 2019 (Wednesday) 9:30 AM — 12:00 PM at the Food and Drug Action Center (FDAC) Meeting Room, located at 3rd Level of Starmall, Alabang, Muntinlupa City.

The Kapihan at Talakayan aims to provide a venue for discussion, clarification, and/or suggestion on the implementation of FDA Citizen’s Charter on Application for Food Suitability Evaluation of Food Contact Articles (Voluntary).

All interested parties may signify their attendance thru registration by e-mail at [email protected], [email protected], and [email protected] Registration shall be on a first come, first served basis and one (1) representative shall be allowed per company.

A total of fifteen (15) slots shall be made available and confirmation as attendee shall also be made via e-mail.

For your information and guidance.

Attachment:-> KAPIHAN AT TALAKAYAN SA FDA FOR MANUFACTURERS AND DISTRIBUTORS OF FOOD CONTRACT ARTICLES

Please be informed that the IT System of the Information and Communication Technology Management Division of the Policy and Planning Services (PPS-ICTMD) will be undergoing check and maintenance in order to migrate from a local server to Cloud on October 31 at (6PM) to November 4, 2019 at (5AM).

We regret to inform you that all ICTM system will be temporarily unavailable.

We sincerely apologize.

Thank you for your cooperation and understanding.

Attachment:-> FDA SYSTEM MAINTENANCE from October 31 to November 4 2019

This is to inform all concerned stakeholders that the “Regional Cascading of Administrative Orders on the Regulation of Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations (IRR) of RA 10620” in Davao City will not push through on 24-25 October 2019 due to low number of registered participants.

The new schedule and confirmed venue will be announced accordingly.

For your information and guidance.

Thank you.

Attachment:-> Cancellation of Regional Cascading of Administrative Orders on the Regulation of (HUHS) ,(HUPs), and (PCOs) Pesticide Handlers, and Implementing Rules and Regulations (IRR) of RA 10620 in Davao City

Press Release 15 October 2019

On 04 September 2019, the Regional Trial Court in Mandaluyong City promulgated a Judgment against Leo Plantilla Ortiz (Ortiz), owner of JLO General Merchandise, finding him guilty of violation of Republic Act No. 9711. He was sentenced to pay the fine of One Hundred Thousand Pesos (Php100,000.00).

The accused Ortiz was found to have willfully, unlawfully and feloniously, manufactured or caused the manufacture of different health products identified as: (a) 12-in-1 Gluta Lipo with Glutathione and L- Carnitine Lemon Flavor (also referred to as Gluta Lipo 12-in-1 (Glutathione) Whitening and Slimming Juice, 12- Gluta Lipo Whitening Juice(Glutathione); (b) 12-in1 Gluta Lipo Detox Coffee (also referred to as 12-in-1 Gluta Lipo Detox Coffee (Glutathione); and (c) Gluta Lipo Ultima Plus capsules without first registering said products before the Food and Drug Administration (FDA). The agents of the Regulatory Enforcement Unit of the FDA made the arrest and filed criminal charges against the accused.

He was charged of clearly violating Section 10 (a) and (j) Republic Act No. 9711 known as the Food and Drug Administration Act (FDA) of 2009, amending Section 11 of Republic Act No. 3720, as amended, which provide:

“SEC. 10. Section 11, subsections (a), (b), (d), (g), (j), (k) and (l) of Republic Act No. 3720, as amended, are hereby further amended to read as follows:

“SEC. 11. The following acts and the causing thereof are hereby prohibited:

“(a) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded.

“6) The manufacture, importation, exportation, sale, offering for sale, distribution,

transfer, non-consumer use, promotion, advertisement, or sponsorship of any health

product which, although requiring registration, is not registered with the FDA

pursuant to this Act.”

In a statement, Undersecretary for Health and FDA’s Director General, Rolando Enrique D. Domingo, declared that this verdict of the Court shall serve as a warning to all concerned people or entities to strictly comply with the provisions of Republic Act No. 3720, as amended, and further amended by Republic Act No. 9711, as well as, other FDA-implemented laws and secure the required appropriate licenses to operate an establishment and register their products.

“To those who continue with their illegal and nefarious activities of manufacturing, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the benefit of registration and license to operate, at the expense of the health of the people, the FDA shall be relentless in pursuing legal actions against them,” he said.

DATE: 21, 22, 24, 25, 28, 29 & 30 October 2019
VENUE: Venue to be Determined within Cagayan de Oro, Davao City, Ilo-ilo City, and Pampanga

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct a “Regional Cascading of the Administrative Orders on the Regulation of Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations of RA 10620” on the following dates:

All concerned stakeholders are invited to attend. Registration through this LINK  is on a first-come, first-serve basis as only the first one-hundred (100) pre-registrants (per session) shall be accommodated. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] .

Attachment:-> Announcement – Regional Cascading of 4AOs

To: ALL INTERESTED/ACCRECITED SUPPLIERS:

This pertains to the Opening of Bids on 04 October 2019 (Friday) at 1:30 PM for the above stated project. Kindly be advised that the City Health Office of Muntinlupa City had announced that they will be conducting fumigation at the FDA premises on the same date at 12:01 after the “Orientation on Awareness of Dengue” thus employees were advised to vacate the premises.

In this regard, the venue for the Bid Opening of the above stated project will be transferred from FDA-BAC Secretariat Room , Annex Bldg, Food and Drug Administration, Civic Drive, Filinvest Corporate City, Alabang City to the FDAC Office, 3r^d Floor Starmall, Alabang, Muntinlupa City.

For information and please be guided accordingly.

Attachment:> Bid Supplement Notice of Transfer of Venue

The Department of Health – Food and Drug Administration released recently an advisory warning retailers on promoting and selling of alcoholic beverages to minors (below 18 years old). This is in light of recent reports that alcopops, sweet and often fruit-flavored or fizzy alcoholic beverages, are being sold by retailers, such as supermarkets, groceries and convenience stores to minors, alongside with juice drinks and other non-alcoholic beverages.

To ensure health and welfare of minors and to remind retailers on the ethical sale of alcoholic beverages, the DOH-FDA is sternly reminding all retailers to refrain from the promotion and selling of all alcoholic beverages, especially alcopops, to minors. Further, retailers are reminded to include appropriate prominent signage for liquors/alcoholic drinks in their respective stores and ensure the conduct of appropriate verification of age of customers.

The general public is enjoined to be vigilant from food retailers who continuously sell alcoholic beverages to minors. Please report these erring food retailers to eReport, the online reporting facility of the Food and Drug Administration, which can be accessed at www.fda.gov.ph/ereport or call 857-1900 local 8112 and 8115.

Attachment-> : Press Release 22 August 2019

A N N O U N C E M E N T

Please be informed of the following changes of the FDA Academy QPIRA Seminar for Center for  Cosmetics  Regulation  and  Research  for  Mindanao  Stakeholders  (QCCRR-MIN)  and Unified  Licensing  Seminar   for  Region  X  (ULS-RX) in observance of the local holiday in Cagayan de Oro City on 28 August 2019:

Our sincere apologies for any inconvenience this change in seminar schedule have cause.

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected].

Please be guided accordingly.

Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX

to continue reading, click the link below…

https://drive.google.com/file/d/1Vy4tco-_E9mmk-oinxWRf-rFUzDhY03x/view?usp=sharing

Please be informed that the Center for Food Regulation and Research (CFRR) will conduct its Strategic Planning on 29-31 May 2019 within CALABARZON area.

All transactions will be entertained until 28 May 2019 and will resume on June 2019.

Center for Food Regulation and Researh (CFRR) Strategic Plan on 29-31 May 2019

Field Regulatory Operations Office (FROO)-South Luzon Cluster will conduct its Operational Planning and Team Building on 28-31 May 2019 within Calabarzon area.

In this regard, skeletal workforce is maintained on the said period. Regular operations will resume on MONDAY, 03 June 2019.

For information and guidance of all concerned stakeholders.

FROO operational Planning and Team Building on 28-31 May 2019

FPO NO2019-0311-Designation of ATTY. RONALD R. DE VEYRA, MBA, CESO II, as Officer-in-Charge of Legal Services Support Center (LSSC).

For your information and guidance.

Thank you.

FPO2019-0315-Designation of DR. CYNTHIA R ROSUMAN, Director III as Officer-in-Charge of Food and Drug Action Center (FDAC).

For your information and guidance.

Thank you.

FPO2019-0314-Designation of MERLITO Y. AGUIHAP as Officer-in-Charge of Information Communication and Technology Management Division (ICTMD).

For your information and guidance.

Thank you.

FPO2019-0313-Designation of DR. OSCAR GUTIERREZ,Chief of Policy Formulation and Program Division as Officer-in Charge of Policy Planning Service (PPS).

For your information and guidance.

Thank you.

May 21, 2019

Press Release

The Philippine Nuclear Research Institute- Department of Science and Technology (PNRI-DOST) recently reported that as many as eight out of ten vinegar products are not made from natural sources. According to the report, such products did not undergo the natural process of fermentation of acetic acid, which is the usual process of making vinegar.

Please be informed that the venue of the Unified Licensing Seminar (ULS – RVIII) on 21 May 2019 will be in TACLOBAN XYZ CORPORATION HOTEL XYZ, P. ZAMORA ST. TACLOBAN CITY

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

• Course Assessment Slip
• Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RVIII) ON 21 MAY 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – CAR) on 21 & 22 May 2019 will be in CITYLIGHT HOTEL, 245 Upper General Luna Road, Baguio City

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

• Course Assessment Slip
• Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

PH FDA QUALIFIES AS 5th ASEAN LISTED INSPECTION SERVICE – The Philippine Food and Drug Administration (FDA) has successfully qualified as the 5th ASEAN Listed Inspection Service with the completion of the onsite audit by the Panel of Experts last month. It is now preparing to summit its intent to apply for membership to the prestigious Pharmaceutical Inspection Co-operation Scheme (PIC/S). Shown in the photo are: FDA Director General Nela Charade G. Puno (2nd from Right) in the committee meeting in Geneva, Switzerland to signify FDA’s intent to submit its application for membership. With her are (from left): FDA OIC Deputy Director-General for Field regulatory Operations Office Atty. Emilio L. Polig Jr., current PIC/S Chairman Boon Meow Hoe (Singapore/HSA); and incoming PIC/S chairman Ms. Anne Hayes.

PRESS RELEASE

MAY 12, 2019

The Food and Drug Administration (FDA) is set to adopt and implement stricter safety and quality standards for vinegar products being sold in the market today, following reports that most of these products are made from synthetic raw materials that may pose health hazards.

The Food and Drug Administration (FDA) is reiterating its warning to the public against the administration, sale, and consumption of the anti-hypertension drug product, Losartan Potassium + Hydrochlorothiazide 100mg/25mg Tablet, Director General Nela Charade G. Puno said.

The FDA particularly warns on the drug manufactured by Lek Pharmaceuticals dd, Ljubljana in Slovenia, on a particular batch/lot  which is being voluntarily recalled by Sandoz Inc., per the recent public advisory released by the United States (US) FDA.

The Active Pharmaceutical Ingredient (API), Losartan, manufactured by Zhejiang Huahai Pharmaceuticals Co. Ltd. in Linhai, China, was reported to contain trace amount of the impurity, N-nitrosodiethylamine (NDEA).

The said impurity was classified as a probable human carcinogen as per the World Health Organization (WHO) International Agency for Research on Cancer (IARC). Such is the categorization due to limited evidence of carcinogenicity in humans.

Losartan Potassium + Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.

Although limited to a certain batch/lot (Lot No. JB8912), the FDA is currently monitoring the subject drug product through heightened Post Marketing Surveillance (PMS) operations. It is coordinating with its Market Authorization Holder or MAH for its immediate recall in the Philippines, pending confirmation of their safety for public consumption.

Puno warns retail drug outlets, and other dealers of pharmaceutical products against the sale of this affected lot of Losartan + Hydrochlorothiazide 100mg/25mg Tablet.

FDA initially issued the warning last November 2018 but reitrated the advisory again because of the proliferation of tainted Losartan in the market.

“For everyone’s protection, I am calling on the public to report the sale or distribution of the subject drug product despite the issuance of this Advisory. Kindly email us via [email protected].,” Puno requested.

For more information and inquiries, please e-mail  [email protected] or call the  FDA Action Center hotline (02) 821-1162.

Please be informed that the Unified Licensing Seminar for Region VII (ULS-RVII) scheduled on 7 & 8 May 2019 in Cebu shall be in CEBU PALM GRASS HOTEL.

• VENUE          : CEBU PALM GRASS HOTEL
• ADDRESS     : 68 GEN. JUNQUERA ST. KALUBIHAN CEBU CITY, CEBU

All course registrants who received Course Assessment Slip for the Unified Licensing Seminar are advised to immediately send their proof of payment to confirm your slot for ULS-RVII on 7 & 8 May 2019, otherwise your application will be automatically removed in the e-nroll system.

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

SEMINAR VENUE FOR UNIFIED LICENSING SEMINAR FOR REGION VII (ULS-RVII) IN CEBU ON 7-8 MAY 2019

***SYSTEM MAINTENANCE ADVISORY***

Please be informed that the 13 ASEAN Modules and GMP Modules for Cosmetics Manufacturers and Traders (GMP-CMT) scheduled on 24-25 April 2019 shall be held at CRIMSON HOTEL.

• VENUE          : CRIMSON HOTEL
• ADDRESS     : 2609 Civic Drive Filinvest City Alabang, Muntinlupa City

All course registrants who received Course Assessment Slip for the 13 ASEAN Modules and GMP Modules for Cosmetics Manufacturers and Traders but have not received the Course Confirmation Slip are advised to send their proof of payment and bank validated Training Assessment Slip until Friday, 12 April 2019 to confirm their slot for the training.

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

SEMINAR VENUE FOR 13 ASEAN MODULES AND GMP MODULES FOR COSMETICS MANUFACTURERS AND TRADERS (GMP-CMT) SEMINAR ON 24-25 APRIL 2019