Certificate Extension Granted
Last February, PFDA released to FDA Circular No. 2020-024-A or the “Amendment to FDA Circular No. 2020-024-Updated Guidelines for Application of Authorizations with The Food and Drug Administration in Light of The Community Quarantine Declarations.” With the continuing restrictions brought about by the COVID-19 pandemic, the validity of authorizations, LTOs, and CPRs, expiring between January 1- June 30, 2020, has been extended with an additional 4 months from the original expiry of the authorizations. The extension will be only valid if the application for renewal is filed within the given extension period.
As such, manufacturers and importers with authorizations covered by the circular can continue to import, distribute and market medical device products to the Philippines within the extension period. In addition to the certificate, the following shall be used as supporting documents for transactions with Customs:
- - copy of this FDA Circular 2020-024-A
- - PFDA acknowledgment receipt of the renewal application
- - official receipt of the renewal application
FDA Circular 2020-024-A also clarified that authorizations’ validity can only be extended once. If the authorization validity was already extended by PFDA Circular No. 2020-024, it is no longer covered by the present circular. Beyond the extended validity, application submissions will incur surcharges on top of the renewal fees if filed within 120 days after the extended expiry. Beyond 120 days from extended validity, applications will be subject to initial filing with corresponding initial fees and surcharges.
The remaining provisions of FDA Circular No. 2020-024 still hold. Included in this is the priority reviewing of health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and PPE of COVID-19, and essential medicine.
OTHER PFDA Important Announcements
- - Updated Payment Methods to PFDA
- The Landbank Link.Biz Portal is an online platform that can now be utilized by customers to pay for PFDA fees. The source accounts can be any of the following:
1. LANDBANK ATM Savings Account
2. LANDBANK VISA Debit Cards
3. LANDBANK Current Account with ATM Access
4. BancNet-Member Banks ATM Cards
5. International Credit/Debit/Prepaid Cards
6. Globe GCash
7. Cash Payments via 7/11 and Bayad Center
Only payments from Landbank account will be credited in real-time. All other payments will be processed the next banking day. This provides FDA clients an alternative payment mode in addition to Oncol payments that can only be made via over-the-counter transactions in any Landbank branch. Fund transfer option to FDA special fund is no longer accepted.
- - Updated PFDA Citizen’s Charter
- PFDA has already uploaded the latest version of Citizen’s Charter. A citizen’s charter outlines the commitment of an organization to provide quality service to its stakeholders. This document outlines the requirements, PFDA fees, expected reviewing, and turn-around time of various transactions in PFDA. Some important transactions are enumerated in Table 1:
-
PFDA Transaction (Medical Device)
Fee in PhP
Turn-around time
CMDN Initial application
7575
20 working days
CMDL application
510
7 working days
CMDR Class B initial application
7575
60 working days
CMDR Class C and D initial application
7575
90 working days
CMDN/CMDR/IVD Renewal
5050
20 working days
IVD Initial
1515
(Additional 1010 for pregnancy kits
90 working days depending on the NRL evaluation time
Variation CPR/CPN/IVD (Amendment)
510
30 working days
Extension of shelf-life
1010
Brand name change
2525
- Table 1: PFDA Transactions as per latest PFDA Citizen’s Charter
References:
FDA Circular No. 2020-024A