Category: Drugs Announcements

#MedSafetyWeek 2020 Day 5

Ngayong panahon ng pandemya, maging alerto sa mga posibleng side effect mula sa mga gamot at i-report ito sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 4

Ang gamot ay maaring mag-interact sa iba pang gamot, pagkain, at ibang mga produkto. Ugaliing basahin ang patient leaflet ng gamot at mag-report sa FDA kung ikaw ay may naranasang side effect (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 3

Siguraduhing tanungin ang inyong mga pasyente sa anumang side effect na maaring naranasan nila mula pag-inom ng gamot.

I-report ang mga side effect sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Sa paggawa nito, ikaw ay nakatutulong tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 2

Ang bawat report ay mahalaga. Kung sa iyong palagay ikaw ay nakararanas ng panibagong side effect mula sa inyong mga gamot, i-report ito sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

Read more:-> Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

FDA-Advisory-No.2020-1841-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. CSPC® Shuxuening Zhusheye 5mL
2. Lihuapai ATP [as reflected in the secondary packaging]
Adenosine Disodium Triphosphate Tablets
Sanlinsuanxiangan’erna Pian [as reflected in the package insert]
3. Levofloxacin Hydrochloride Tablets 0.1g
4. Zhenyuan® Clarithromycin Tablets 0.25g

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

 Attachment:-> FDA-Advisory-No.2020-1841-A

AMENDMENT OF THE MECHANICS FOR THE POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

 

  1. BACKGROUND

The 2020 National Consciousness Week Against Counterfeit Medicines (NCWACM) will be celebrated by the Food and Drug Administration (FDA) on 16 to 20 November 2020 with the theme, “Sa Gitna ng Pandemya, Magtulungan Laban sa Pekeng Medisina”. The celebration aims to raise more awareness that counterfeit medicines still thrive especially in this time of COVID-19 and to relay the continuous efforts of our partners in combating these counterfeit medicines. In this regard, the Technical Working Group (TWG) of the 2020 NCWACM has lined-up a program and set of activities to engage our partners, stakeholders, and the general public which includes the Poster-Making Contest to allow the general public to showcase their creativity while participating in our cause amidst the pandemic.

  1. ISSUE

On 01 to 02 October 2020, all FDA Personnel were invited through e-mail to participate in the preliminary judging of the 68 submitted poster entries for the Poster-Making Competition. Thereafter, the shortlisted entries/finalists were uploaded on the Facebook page of the FDA Philippines last 03 October 2020 for online voting of each poster entry/finalist by the general public through “Likes”/thumbs-up and/or “Share” with said voting open until 18 October 2020, 11:59 PM.

When shortlisted entries/finalists were uploaded on Facebook, the TWG received complaints (see attached for example) from other participants that some contestants seem to use online bot to gain more shares of their entries.

  1. FINDINGS/COMMENTS/ANALYSIS

The TWG discussed these complaints and the expertise of the Information Communication and Technology Management Division (ICTMD) was requested on how to address these issues, and it was relayed by the ICTMD that it is challenging to detect if an online bot was used. Therefore, the TWG decided to remove the “Shares” in the counting of points to determine the top six (6) winners which shall become official properties of the FDA. It must be noted that the “Share” is equal to three (3) points while the “Like” is only for one (1) point. Attached is the original mechanics of the poster making competition and the following are the revisions for the said contest mechanics:

  • Revise No. 6 to “The finalists shall be uploaded to the FDA Facebook for online voting and online voting shall be open on 03 to 18 October 2020 only. A system shall be used for the awarding of points to each entry wherein ONLY a “Like”/thumbs-up shall be counted and every “Like”/thumbs-up shall be equal to 1 point. Other reactions, e.g., heart, care, etc., shall not be given any points and the winners shall be determined from the likes garnered on the entries posted on the FDA Facebook.

Also, an announcement shall be released on the Facebook page of the FDA Philippines and appropriate notice through e-mail shall be sent to all finalists regarding the revision of the mechanics of the poster making competition.

  1. RECOMMENDATION

For fair competition, the TWG recommends the following:

  • Allow the revision of the mechanics;
  • Permit the posting of the announcement on the Facebook page of the FDA Philippines regarding the revised mechanics of the Poster-Making Competition for public dissemination.

Attachment:->  2020 NCWACM Poster Making Contest-Revision of Mechanics for Online Voting

 

 

ANNOUNCEMENT || POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

  1. BACKGROUND

By virtue of the Republic Act No. 8203 otherwise known as the “Special Law on Counterfeit Drugs” issued on the 19th of November 1996, this was established to:
1) protect and promote the right to health of the people and instill health consciousness among them as provided in Section 15 Article 11 of the constitution; and 2) to further declare the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

  1. ISSUE

On 15 June 2010, Presidential Proclamation No. 2082 was issued to declare the third week of November of every year as the “National Consciousness Week against Counterfeit Medicines”. As such, it’s directed for the: 1) planning, coordination, and implementation of comprehensive public awareness programs and activities on counterfeit medicines through a collaborative inter-agency and multi-sectoral effort at all levels, and 2) to particularly ensure widespread and expeditious public information about the proliferation and dangers of counterfeit medicines.

In this regard, the FDA through the Center for Drug Regulation and Research shall be spearheading the 2020 NCWACM with the theme, “Sa Gitna ng Pandemya, Magtulungan Laban sa Pekeng Medisina” through a virtual celebration, i.e., webinar. Also, it was decided that to engage the general public, an online poster making contest is recommended.

  1. FINDINGS/COMMENTS/ANALYSIS

In line with the abovementioned proposed poster making contest, the technical working group for the observance of the 2020 NCWACM proposes the following:

  1. The contest is open to all ages.
    1. The poster must illustrate, interpret, and emphasize the theme of the 2020 NCWACM.
    2. The poster must be in PNG format, 24 x 36 size, and with 4000 pixels by 6000 pixels.
    3. All entries must be submitted on 25 to 30 September 2020 only to [email protected] with the subject of e-mail as “2020 NCWACM Poster” and the body of the e-mail containing your full name, complete address, and contact details.
    4. There shall be a preliminary judging of all the submitted entries by the FDA through dissemination of the google form link through e-mail using the following criteria:
    • Relevance to the theme: 30%
    • Creativity & Presentation: 30%
    • Originality: 30%
    • Compliance with Requirements: 10%
    1. The finalists shall be uploaded to the FDA Facebook for online voting and online voting shall be open on 03 to 18 October 2020 only. A system shall be used for the awarding of points to each entry wherein one (1) point shall be given for every “Like” or thumbs-up and three (3) points for every “Share” of the entry;
    2. The top six (6) entries shall be awarded with the following prizes:
    • Grand Prize (One Entry) = 15,000
    • 1st Runner-Up = 12,000
    • 2nd Runner-Up = 10,000
    • 3rd Runner-Up = 8,000
    • 4th Runner Up = 5,000
    • 5th Runner Up = 3,000

     

    Furthermore, the top six (6) entries shall become the properties of Food and Drug Administration, which shall be used as Information, Education, and Communication (IEC) materials.

    1. RECOMMENDATION

     

    1. To launch an online poster making competition to allow the general public to showcase their creativity while participating in our cause amidst the pandemic.
    2. To allow the posting of the announcement for poster making contest in the FDA website and FDA Facebook.

 

Attachment:->  POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

Extension of comments for Draft FDA Circular on Interim Guidelines for the Issuance of Foreign cGMP Clearance

Please be informed that the CDRR is extending the deadline from 10 June 2020 at 3:00PM to 11 June 2020 at 5:00pm of soliciting for comments from the concerned stakeholders on the draft FDA Circular entitled:  Interim Guidelines for the Issuance of Current Good Manufacturing Practice (cGMP) Clearance to Foreign Drug Manufacturers

Comments may be submitted by email to: [email protected] not later than 11 June 2020 (Thursday) at 5:00PM using the following format:

Name of Company/Organization:
Contact information
Telephone number: Email address:
Section Comments Input/Recommendation/
Suggested text (if any)

In sending your comments, please use the subject: [Comments] Interim Guidelines for FcGMP Clearance

Thank you.

Attachment:-> Extension of comments for Interim Guidelines for FcGMP Clearance

Media Announcement of Seapharma International, Inc. on the Recall of Affected Batches of Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)

SUMMARY

Reason for Announcement: Out-of-Specification (Failed Assay) in the Laboratory Analyses
Marketing Authorization Holder (MAH): Seapharma International, Inc.
Product Description: Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)
Registration Number: DRP-6090 & DR-XY44331

The stated MAH released their media announcement (see attached) on their voluntary recall of the aforementioned drug products. The said press release was also uploaded in their official website/account at https://www.facebook.com/112180080343640/posts/114987580062890/?d=n.

For more information and inquiries, please e-mail us at [email protected]. To inform us on the continuous sale or distribution of recalled health products, kindly report through the online reporting facility, eReport, at http://www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> Media Announcement-Prilsea 10 and Prilsea 20

/ In Drugs Announcements / By Administrator / Comments Off on Media Announcement of Seapharma International, Inc. on the Recall of Affected Batches of Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)

List of Authorized Biosimilars (as of 1 January 2019)

The first regulation on pharmaceuticals was in 1989 this include registration of vaccines. In 2001 the specific regulation of vaccines and biological products was signed into law, this provides guidance on how to register vaccines and biologicals in the country. Through the years we have seen a number of developments and innovations in the field of biologicals. However, their cost has often been high which limits the access of patients in developing countries. The expiration of patents of innovative biological products has ushered in a new phase in biological product development in which a product may be considered “similar” to the innovator. This resulted in the issuance of guidelines on “biosimilar” or “similar biotherapeutic” products in 2014.

Since then the FDA has licensed four (4) biosimilar products namely:

  • Insulin Glargine (Basaglar) 100 IU / mL
  • Insulin Glargine (Basaglar Kwikpen) 100 IU / mL
  • Filgrastim (Zarzio) 30 MU / 0.5 mL
  • Rituximab (Truxima) 500mg / 50 mL
No. COMPANY REGISTRATION NUMBER ACTIVE SUBSTANCE BRAND NAME PHARMACOLOGIC CATEGORY STRENGTH FORM MANUFACTURER PACKAGING
1 ELI LILLY (PHILIPPINES), INC. BRP-058 Insulin Glargine Basaglar Antidiabetic 100 Units/mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
2 ELI LILLY (PHILIPPINES), INC. BRP-059 Insulin Glargine Basaglar Kwikpen Antidiabetic 100 Units/ mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
3 Sandoz Philippines Corporation BR-1198 Filgrastim Zarzio Immunostimulant, colony stimulating factor 30 MU/0.5mL Solution for Injection / Infusion IDT Biologika GmbH, Germany Pre-filled syringe (type I glass) with injection needle (stainless steel), with a needle safety guard, containing 0.5mL solution (box of 5’s)
4 Celltrion Healthcare Philippines Inc. BR-083 Rituximab Truxima Antineoplastic 500 mg/50 mL Concentrate for Solution  for Infusion Celltrion Incorporated (Plant 2), Korea 50 mL Type I borosilicate glass vial with rubber stopper and flip-off seal (Box of 1’s)

CDRR Officers of the Day for 9-11 and 13 December 2019

In view of the Performance Review and other FDA activities scheduled on 9-11,13 December-2019, please be- informed that there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Walk-in clients may also opt to approach the Public Assistance desk located in the FDAC.

For your information and guidance.

Attachment:->CDRR Officers of the Day for 9-11 and 13 December 2019

 

children birthday backdrops/birthday backdrops for photography/backdrop for boys birthday party

#MedSafetyWeek (28 November 2019)

New problems in a patient on multiple medications may be side effects or interactions. Is your patient taking too many products? Review their prescriptions and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

#MedSafetyWeek (27 November 2019)

Sometimes you need to take more than one medicine for long-term or complex conditions. Be vigilant about side effects! Report them here:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

#MedSafetyWeek (26 November 2019)

Some medicines should not to be taken with other medicines or with certain foods. Always read the leaflet and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

 

CDRR Officers of the Day for 1-2 October 2019

The Center for Drug Regulation and Research (CDRR) will be Having its Operational Planning on 1-2 October 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected] and we will respond accordingly.

For your information and guidance.

National Consciousness Week Against Counterfeit Medicines 2019

Heads Up Poster Makers!

Be part of the National Consciousness Week Against Counterfeit Medicines 2019 Poster Making Contest with a THEME:

” PAMBANSANG REGULASYON PAGTIBAYIN, PEKENG GAMOT SUGPUIN “

For the Registration Form, kindly download the attachment below…

Attachment-> : Registration Form

CDRR Officers of the Day for 17-19 July 2019

The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly.

For your information and guidance.