PFDA released two consecutive guidelines, FDA Circular No. 2020-0024 and FDA Circular No. 2020-0026, to update existing regulation for the transactions allowed during the quarantine period and to finalize previously drafted regulation for the new normal operations.

Under FDA Circular No. 2020-0024, the following guidelines were mentioned:

  1.       1) License to Operate (LTO) applications were resumed but priority will be given to establishments that will cater products related to COVID-19. 
  2.       2) Certificate expiry and Product Renewal: An automatic 4 months extension was granted to LTOs, CPRs and CPNs expiring on 01-Jul-20 to 31-Dec-20. During importation and securing clearances  with Bureau of Customs, a copy of the circular must be attached after the LTO or CPR/CPN expiry. 
  3.       3) PFDA Payments: Over-the-counter payments were suspended. Applicants must use other payment channels such as On-Coll payment or online payment.  
  4.       4) Certificate Release: Copies of certificates will be sent to registered e-mail address of the authorized representative per company while the hard copies will be mailed to respective company office.

FDA Circular No. 2020-0026, on the other hand, provide the specific details initially mentioned by 2020-024.  In this document, online transactions became the mode of transacting with PFDA until further notice. All face-to-face transactions were suspended until further notice.  Here are the other guidelines discussed in this announcement:

      1) Specific details on the e-mail format for inquiries, applications and compliances were also given. 

      2) Renewal, amendment and correction of CPRs were also resumed. However, for ever company, renewal applications are limited to 5 per week while amendment and correction is 2 per week. 

      3) Non-COVID-19-related CMDR applications will only be entertained starting September 17.

Both guidance effectively repeals the previously released FDA Circular No. 2020-006 and its amendments.


FDA Circular No. 2020-024

FDA Circular No. 2020-026